Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Jun. 30, 2017 | Aug. 08, 2017 | |
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, 2017 | |
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 | 35,742,655 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2017 | Sep. 30, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 66,563 | $ 39,833 |
Accounts receivable | 4,577 | 4,336 |
Unbilled accounts receivable | 260 | 346 |
Inventories, net | 2,521 | 2,424 |
Prepaid expenses and other current assets | 1,133 | 1,341 |
Total current assets | 75,054 | 48,280 |
Restricted cash | 666 | 666 |
Property and equipment, net | 12,451 | 11,147 |
Intangible assets, net | 7,356 | 7,057 |
TOTAL ASSETS | 95,527 | 67,150 |
Current liabilities: | ||
Accounts payable | 5,404 | 2,737 |
Accrued expenses and other current liabilities | 4,925 | 4,271 |
Long-term debt, current portion | 54 | 77 |
Capital lease obligations, current portion | 72 | |
Recall liability, current portion | 160 | 460 |
Deferred contract revenues, current portion | 121 | 355 |
Total current liabilities | 10,664 | 7,972 |
Long-term debt, net of current portion | 52,040 | 50,966 |
Recall liability, net of current portion | 1,808 | 1,859 |
Deferred contract revenues, net of current portion | 3,500 | 3,500 |
Total liabilities | 68,012 | 64,297 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, par value of $0.001 per share, 150,000,000 shares authorized; 35,739,278 and 22,391,631 shares issued and outstanding as of June 30, 2017 and September 30, 2016 | 36 | 22 |
Additional paid-in capital | 229,817 | 170,319 |
Accumulated deficit | (202,338) | (167,488) |
Total stockholders’ equity | 27,515 | 2,853 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 95,527 | $ 67,150 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2017 | Sep. 30, 2016 |
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 | 35,739,278 | 22,391,631 |
Common stock, shares outstanding | 35,739,278 | 22,391,631 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenues: | ||||
Product revenues | $ 5,906 | $ 7,264 | $ 16,301 | $ 18,930 |
Contract research and development revenues | 1,936 | 1,983 | 5,320 | 4,228 |
Other revenues | 267 | 1,359 | 801 | 1,947 |
Total revenues | 8,109 | 10,606 | 22,422 | 25,105 |
Costs and operating expenses: | ||||
Cost of product revenues | 3,935 | 4,626 | 10,892 | 12,924 |
Cost of contract research and development revenues | 2,977 | 2,742 | 7,891 | 8,601 |
Research and development expenses | 9,122 | 5,516 | 22,650 | 15,566 |
General and administrative expenses | 3,284 | 3,116 | 9,288 | 9,106 |
Amortization of intangible assets | 159 | 168 | 514 | 489 |
Loss on disposal of equipment | 6 | 6 | 2 | |
Total costs and operating expenses | 19,483 | 16,168 | 51,241 | 46,688 |
Loss from operations | (11,374) | (5,562) | (28,819) | (21,583) |
Interest income | 77 | 54 | 149 | 142 |
Interest expense | (2,087) | (1,984) | (6,178) | (5,932) |
Loss before income taxes | (13,384) | (7,492) | (34,848) | (27,373) |
Income tax expense | 2 | 3 | ||
Net loss and comprehensive loss | $ (13,384) | $ (7,492) | $ (34,850) | $ (27,376) |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.43) | $ (0.34) | $ (1.30) | $ (1.23) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted (in shares) | 31,457,702 | 22,321,581 | 26,784,678 | 22,254,849 |
STATEMENT OF STOCKHOLDERS' EQUI
STATEMENT OF STOCKHOLDERS' EQUITY - 9 months ended Jun. 30, 2017 - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2016 | $ 22 | $ 170,319 | $ (167,488) | $ 2,853 |
Balance (in shares) at Sep. 30, 2016 | 22,391,631 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of common stock in connection with February 2017 public offering, net of issuance costs | $ 7 | 18,507 | 18,514 | |
Issuance of common stock in connection with February 2017 public offering, net of issuance costs (in shares) | 6,666,667 | |||
Issuance of common stock in connection with May 2017 public offering, net of issuance costs | $ 7 | 37,615 | 37,622 | |
Issuance of common stock in connection with May 2017 public offering, net of issuance costs (in shares) | 6,440,000 | |||
Issuance of common stock under Employee Stock Purchase Plan | 436 | 436 | ||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 134,855 | |||
Issuance of common stock upon exercise of stock options | 229 | 229 | ||
Issuance of common stock upon exercise of stock options (in shares) | 98,625 | |||
Restricted stock units vested (in shares) | 7,500 | |||
Stock-based compensation expense | 2,711 | 2,711 | ||
Net loss and comprehensive loss | (34,850) | (34,850) | ||
Balance at Jun. 30, 2017 | $ 36 | $ 229,817 | $ (202,338) | $ 27,515 |
Balance (in shares) at Jun. 30, 2017 | 35,739,278 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss and comprehensive loss | $ (34,850) | $ (27,376) |
Adjustments to reconcile net loss to net cash used by operating activities: | ||
Depreciation and amortization of property and equipment | 801 | 1,375 |
Loss on disposal of equipment | 6 | 2 |
Amortization of intangible assets | 514 | 489 |
Noncash amortized debt issue costs on long-term debt and capital leases | 273 | 155 |
Noncash amortized discount on long-term debt and capital leases | 12 | 15 |
Stock-based compensation expense | 2,711 | 2,540 |
Issuance of payment-in-kind notes in lieu of cash interest payments | 1,369 | 1,326 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (241) | 370 |
Unbilled accounts receivable | 86 | 295 |
Inventories | (97) | 72 |
Prepaid expenses and other current assets | 208 | (92) |
Accounts payable | 2,530 | (748) |
Accrued expenses and other current liabilities | 110 | (196) |
Deferred contract revenues | (234) | 158 |
Recall liability | (351) | (558) |
Net cash used by operating activities | (27,153) | (22,173) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (1,974) | (1,056) |
Payments for patents and licensing rights | (813) | (724) |
Change in restricted cash | (666) | |
Net cash used by investing activities | (2,787) | (2,446) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net of issuance costs | 56,136 | |
Payment of transaction costs associated with issuance of long-term debt | (200) | |
Principal payments on long-term debt | (58) | (53) |
Principal payments on capital lease obligations | (73) | (610) |
Proceeds from exercise of stock options | 229 | 170 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 436 | 488 |
Net cash provided (used) by financing activities | 56,670 | (205) |
NET INCREASE/( DECREASE) IN CASH AND CASH EQUIVALENTS | 26,730 | (24,824) |
CASH AND CASH EQUIVALENTS - Beginning of period | 39,833 | 72,218 |
CASH AND CASH EQUIVALENTS - End of period | 66,563 | 47,394 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 4,524 | 4,434 |
Cash paid for income taxes | 4 | 3 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Property and equipment purchases included in accounts payable | 310 | $ 65 |
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, 2017 | |
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, 2017, statements of operations and comprehensive loss for the three and nine months ended June 30, 2017 and 2016, statement of stockholders’ equity for the nine months ended June 30, 2017, and statements of cash flows for the nine months ended June 30, 2017 and 2016 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, 2017, its results of operations for the three and nine months ended June 30, 2017 and 2016, and its cash flows for the nine months ended June 30, 2017 and 2016. 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, 2017 are not necessarily indicative of the results to be expected for the year ending September 30, 2017 or for any future annual or interim period. The balance sheet as of September 30, 2016 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, 2016 included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on December 20, 2016. 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, 2016. Liquidity With the exception of fiscal 2013, the Company has incurred losses from operations since fiscal 2006 and has an accumulated deficit of $202.3 million as of June 30, 2017. The Company has financed its operations primarily through the proceeds from the sale of equity securities, and various debt and capital lease financings. The Company believes that its existing cash and cash equivalents will not be sufficient to fund operations in compliance with its debt covenants as currently planned through the next 12 months, which raises substantial doubt about the Company’s ability to continue as a going concern. The Company has based this belief on assumptions and estimates that may prove to be wrong, and the Company could spend its available financial resources less or more rapidly than currently expected. The Company will continue to require additional sources of cash to develop product candidates and to fund development and commercialization operations. Management intends to seek additional capital through collaborative or other funding arrangements with partners, equity and/or debt financings, or through other sources of financing. The Company is also pursuing alternatives to its current debt covenants, including refinancing the existing debt. In the event that additional financing is required from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may be required to significantly delay, scale back or discontinue one or more of the product development programs or commercialization efforts or other aspects of the Company’s business plans, and its business, operating results and financial condition would be adversely affected. The Company is currently in compliance with the covenants under the Company’s term loan agreement with CRG, a structured debt and equity investment management firm. However, the Company anticipates that, based on its current operating plan for products and services currently under contract, and without securing additional sources of external funding, its current cash and cash equivalent balances will not be sufficient to maintain compliance with the minimum liquidity financial covenant through the next 12 months or the minimum annual revenue covenant of $50.0 million for the 12 months ending June 30, 2018. Failure to meet either covenant would be considered an event of default on the Company’s debt obligation, and could result in the acceleration of the Company’s existing indebtedness, causing the outstanding principal of approximately $52.5 million, plus an early prepayment premium and an additional fee, to be immediately due and payable to CRG. As of June 30, 2017, the prepayment premium was 7.5% and the additional fee was 1.0%. The Company may not have sufficient cash and cash equivalents to repay all of the outstanding debt in full if repayment of such debt were accelerated. Due to these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed financial statements as of June 30, 2017 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to secure new sources of revenue, obtain additional equity and/or debt financing or refinancing, generate operating efficiencies, reduce expenditures and amend or obtain a waiver on the financial covenants of the existing term loan agreement with CRG. The unaudited condensed financial statements as of June 30, 2017 do not include any adjustments that might result from the outcome of this uncertainty. 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 the three and nine months ended June 30, 2017, three partners accounted for 96% and 93% of the Company’s revenues and three partners accounted for 97% of accounts receivable as of June 30, 2017. For the three and nine months ended June 30, 2016, three partners accounted for 84% and 85% of the Company’s revenues. As of September 30, 2016, four partners accounted for 84% of accounts receivable. Restricted Cash The Company’s restricted cash consists solely of cash maintained in a separate deposit account used to secure a letter of credit issued by a bank to a former landlord pursuant to a terminated lease agreement. The Company has classified the restricted cash as noncurrent on the condensed balance sheet. Comprehensive Income (Loss) For the three and nine months ended June 30, 2017 and 2016, 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. Reclassifications The Company reclassified certain balances in the condensed statements of cash flows for prior periods to conform to current presentation. The reclassifications did not impact total cash flows from operating, investing or financing activities. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2017 | |
Fair Value Measurements | |
Fair Value Measurements | 2. Fair Value Measurements Financial assets and liabilities are recorded at fair value. Except as noted below, the carrying values of the Company’s financial instruments, including cash equivalents, accounts receivable, and accounts payable, approximated their fair values due to the short period of time to maturity or repayment. Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset, or an exit price that would be paid to transfer a liability, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level I —Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level II —Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level III —Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The Company did not have any transfers between Levels I, II and III of the fair value hierarchy during the nine months ended June 30, 2017. 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, 2017 Level I Level II Level III Total Financial Assets: Money market funds $ 67,664 $ — $ — $ 67,664 As of September 30, 2016 Level I Level II Level III Total Financial Assets: Money market funds $ 39,950 $ — $ — $ 39,950 The Company did not have Level II or Level III liabilities as of June 30, 2017 and September 30, 2016. The carrying values of the Company’s long-term debt reflects the principal amount, adjusted for any unamortized debt issuance costs and discount. The following financial liabilities have carrying values that differ from their fair value as estimated by the Company based on market quotes for instruments with similar terms and remaining maturities (Level III valuation) (in thousands): As of June 30, 2017 Carrying Fair Value Value Difference Long-term debt $ 52,094 $ 52,971 $ 877 As of September 30, 2016 Carrying Fair Value Value Difference Long-term debt $ 51,043 $ 51,649 $ 606 |
Inventories
Inventories | 9 Months Ended |
Jun. 30, 2017 | |
Inventories | |
Inventories | 3. Inventories Inventories consist of the following (in thousands): As of June 30, As of September 30, 2017 2016 Raw materials $ 1,430 $ 1,307 Work in process 366 411 Finished goods 725 706 Total inventories $ 2,521 $ 2,424 |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Jun. 30, 2017 | |
Long-Term Debt. | |
Long-Term Debt | 4. Long-Term Debt Outstanding long-term debt consists of the following (dollars in thousands): As of June 30, As of September 30, 2017 2016 Term loan agreement expiring June 30, 2019, less unamortized issuance costs of $817 and $544 and unamortized discount of $31 and $43 as of June 30, 2017 and September 30, 2016. See terms of the agreement below. $ 51,654 $ 50,546 Notes payable to lessor for tenant improvements. The note calls for monthly payments of principal and interest of $3 at an interest rate of 7% and is due September 2017 9 34 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 431 463 Total 52,094 51,043 Less current portion 54 77 Long-term portion $ 52,040 $ 50,966 On July 13, 2012, the Company completed a $35.0 million term loan agreement with CRG, a structured debt and equity investment management firm. In August 2012 and December 2012, the Company drew down $29.0 million and $6.0 million under this agreement. On November 14, 2014, the agreement was amended to, among other things, increase the principal amount available under the term loan by $10.0 million, extend the interest-only period to June 30, 2018, and extend the maturity from June 30, 2017 to June 30, 2019. The amended agreement provides for a maximum borrowing of $45.0 million, excluding PIK notes, as defined below. The amended agreement requires interest to be paid quarterly at a simple annual rate of 15%, and all outstanding principal be repaid in four equal quarterly payments beginning on June 30, 2018, with interest continuing to accrue on the unpaid principal at a simple annual rate of 15%. In addition, the amended agreement contains a provision whereby the Company can, at each quarterly payment due date prior to June 30, 2018, choose to convert that portion of each quarterly interest obligation equal to 3.5% of the then-outstanding principal into additional notes (payment-in-kind (“PIK”) notes). Amounts outstanding under the term loan agreement are collateralized by all of the Company’s assets. The amended agreement also provides for an early prepayment premium, the amount of which varies with the date on which prepayment is made, if the Company chooses to repay principal prior to June 30, 2018 or upon other specified events, including a change of control. On December 4, 2014, the Company borrowed the remaining $10.0 million of principal provided for in the amended agreement. As of June 30, 2017 and September 30, 2016, the Company had converted $7.5 million and $6.1 million of interest into PIK notes, each of which added to the then-outstanding principal and is included in the balances shown as of those dates. As of June 30, 2017, the principal amount outstanding under the term loan agreement, including all PIK notes, was $52.5 million. The term loan agreement was amended in December 2016 to modify the financial covenants for minimum annual revenues (beginning with the 12 months ended June 30, 2017) in exchange for a fee equal to 1.0% of the aggregate principal amount of all loans and PIKs advanced by CRG to the Company under the term loan agreement. This fee will be due upon the loan maturity date of June 30, 2019 or upon the earlier acceleration of the loan pursuant to its terms. Based on the current loan balance and projected PIK borrowings, this fee is expected to be approximately $0.5 million. The Company has been in continuous compliance with the financial covenants since the inception of the loan. |
Contingencies
Contingencies | 9 Months Ended |
Jun. 30, 2017 | |
Contingencies | |
Contingencies | 5. Contingencies The Company may be subject to legal proceedings and litigation arising in the ordinary course of business. Management is not aware of any legal matters in which the final disposition is expected to have a material effect on the business, except as noted below. On September 23, 2016, a complaint was filed against the Company by LBA Realty Fund III-Company VII, LLC, a Delaware Limited Liability Company (the “Landlord”), in the Superior Court of California, County of Alameda, LBA Realty Fund III-Company VII, LLC vs. Corium International, Inc. , alleging breach of contract with respect to the lease agreement dated February 12, 2016 between the Landlord and the Company. The complaint alleges that the Company breached the lease when the Company provided written notice to the Landlord to terminate the lease on July 29, 2016 and seeks damages in excess of $10.0 million as well as declaratory relief. On or about November 16, 2016, the Company filed its answer generally denying the allegations and setting forth its defenses. At the same time, the Company filed a cross-complaint seeking compensatory damages, among other relief, for the Landlord’s material breaches with respect to the lease agreement. The parties are currently engaged in discovery. The parties have also participated in an initial mediation, and may participate in further mediation after further discovery has taken place. A Case Management Conference has been scheduled for January 23, 2018. A trial date of May 11, 2018 has been set. At this time, the Company is unable to assess whether any loss or adverse effect on the Company’s financial condition is reasonably possible as a result of this lawsuit or to estimate the range of any potential losses. Accordingly, the Company has not accrued any liability associated with this complaint. The Company does not believe that this lawsuit has any merit, and plans to defend vigorously against this claim, while prosecuting its cross-complaint. |
Collaboration and Partner Arran
Collaboration and Partner Arrangements | 9 Months Ended |
Jun. 30, 2017 | |
Collaboration and Partner Arrangements. | |
Collaboration and Partner Arrangements | 6. 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, 2017 2016 2017 2016 Mayne $ 2,207 $ — $ 4,411 $ — Teva — 2,708 — 5,504 Endo / Par — 1,853 363 5,445 P&G 4,406 4,392 12,519 10,294 Agile 1,154 767 4,014 2,182 Other 342 886 1,115 1,680 Total revenues $ 8,109 $ 10,606 $ 22,422 $ 25,105 Included in total revenues above are royalties and profit sharing, which totaled $0.1 million and $0.7 million for the three and nine months ended June 30, 2017, compared to $0.5 million and $1.7 million for the corresponding periods in 2016. In March 2017, Mayne acquired the marketing rights to the Fentanyl Transdermal Delivery System, or Fentanyl TDS, manufactured by the Company. This product is an AB-rated generic equivalent to Duragesic ® , indicated for the management of pain in opioid-tolerant patients. On April 25, 2017, the Company and P&G entered into a commercial supply agreement (the “P&G Supply Agreement”), effective May 1, 2017. Pursuant to the P&G Supply Agreement, the Company will continue to produce and supply to P&G oral care products that are sold under the brand name Crest Whitestrips, at specified pricing levels. The P&G Supply Agreement will remain in effect until March 31, 2022, absent early termination for material uncured breach. |
Warrants
Warrants | 9 Months Ended |
Jun. 30, 2017 | |
Warrants | |
Warrants | 7. 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 2013. The warrants were recorded as equity instruments at the date of their issuances based on the terms of the warrants. As of June 30, 2017 and September 30, 2016, warrants to purchase 51,386 shares of common stock, on an as‑converted basis, were outstanding with a weighted-average exercise price of $9.26 per share. All of the common stock warrants are exercisable at any time up to ten years from issuance. These warrants expire at various dates between December 2020 and November 2021. The fair value of these warrants was recorded in stockholders’ equity upon issuance. |
Convertible Preferred Stock, Co
Convertible Preferred Stock, Common Stock and Stockholders' Equity | 9 Months Ended |
Jun. 30, 2017 | |
Convertible Preferred Stock, Common Stock and Stockholders' Equity - Convertible Preferred Stock | |
Convertible Preferred Stock, Common Stock and Stockholders' Equity | 8. 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, 2017 and September 30, 2016 with a par value of $0.001 per share. No preferred stock was outstanding as of those dates. Common Stock In May 2017, the Company completed an underwritten public offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-208800) of 6,440,000 shares of common stock, including 840,000 shares sold upon full exercise of the underwriters' option to purchase additional shares of common stock, at a public offering price of $6.25 per share. The Company received net proceeds of $37.6 million after deducting underwriting discounts and commissions and other issuance costs and expenses of $2.6 million. In February 2017, the Company completed an underwritten public offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-204025) of 6,666,667 shares of common stock at a public offering price of $3.00 per share. The Company received net proceeds of $18.5 million after deducting underwriting discounts and commissions and other issuance costs and expenses of $1.5 million. The Company was authorized to issue up to 150.0 million shares of common stock as of June 30, 2017 and September 30, 2016 with a par value of $0.001 per share. As of June 30, 2017, there were 35,739,278 shares of common stock outstanding and as of September 30, 2016, there were 22,391,631 shares of common stock outstanding. Controlled Equity Offering In December 2015, the Company entered into a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co., as agent (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell, from time to time through Cantor Fitzgerald, shares of its common stock, par value $0.001 per share, with aggregate proceeds of up to $20.0 million. The offer and sale of these shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-204025) filed by the Company with the SEC on May 8, 2015 and declared effective by the SEC on May 21, 2015, as supplemented by a prospectus supplement dated and filed with the SEC on December 30, 2015. The Company will pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from any shares of common stock sold by Cantor Fitzgerald. The Company has not sold any shares of common stock under this sales agreement. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Jun. 30, 2017 | |
Stock-Based Compensation | |
Stock-Based Compensation | 9. Stock-Based Compensation Equity Incentive Plans As of June 30, 2017 and September 30, 2016, 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 currently can issue shares. 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 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 up to 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 10, 2017 and January 11, 2016, the Company’s board of directors authorized an increase of 902,298 and 888,776 shares to be added to the total number of shares of common stock issuable under the 2014 Plan. As of June 30, 2017 and September 30, 2016, the Company had reserved 5,326,153 and 4,529,980 shares of common stock for issuance pursuant to the 2014 Plan. As of June 30, 2017 and September 30, 2016, the Company had 1,165,519 and 1,192,476 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, 2017 is as follows: Weighted Weighted Stock Average Remaining Aggregate Options Exercise Contractual Intrinsic Value Outstanding Price Life (Years) (In thousands) Balance - September 30, 2016 3,307,504 $ 4.69 6.57 $ 5,538 Options granted 868,450 $ 4.54 Options exercised (98,625) $ 2.33 Options forfeited / cancelled (19,195) $ 7.00 Balance - June 30, 2017 4,058,134 $ 4.70 6.72 $ 12,074 Options exercisable - June 30, 2017 2,696,450 $ 4.16 5.71 $ 9,359 Options vested and expected to vest - June 30, 2017 3,926,337 $ 4.67 6.65 $ 11,794 All outstanding stock options under the Corium Plans as of June 30, 2017 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, 2017 were estimated using the Black-Scholes option-pricing model with the following assumptions: Nine Months Ended June 30, 2017 Expected term (in years) - Risk-free interest rate % - % Expected volatility % - % Expected dividend rate % Expected Term — The expected term represents the period that the stock-based awards are expected to be outstanding before exercise or cancellation. As the Company's historical share exercise experience has not yet provided a reasonable basis upon which to estimate expected term because of a lack of sufficient data points, the Company estimated the expected term by using the midpoint between the vesting commencement date and the contractual expiration period of the stock-based awards. Risk-Free Interest Rate — The risk-free interest rate is based on the constant maturity yields of U.S. Treasury notes with remaining maturities similar to the expected term. Expected Volatility — Because the Company has limited information on the volatility of its common stock due to 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, 2017 is as follows: Weighted Average Number of Grant Date Shares Fair Value Nonvested - September 30, 2016 30,000 $ 7.94 Granted 80,000 4.59 Vested and released (7,500) 7.94 Forfeited — — Nonvested - June 30, 2017 102,500 $ 5.33 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 can be increased by up to 1% of the number of shares of common stock and common stock equivalents outstanding as of the preceding December 31, or a lesser number agreed to by the Company’s board of directors. On January 10, 2017 and January 11, 2016, the Company’s board of directors reserved an additional 267,565 and 257,631 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. As of June 30, 2017 and September 30, 2016, there were 636,399 and 503,689 shares of common stock available for issuance pursuant to the 2014 ESPP. For the three and nine months ended June 30, 2017, the Company recorded stock-based compensation expense related to the 2014 ESPP of $60,000 and $224,000, compared to $79,000 and $217,000 for the corresponding periods in 2016. For the nine months ended June 30, 2017 and 2016, the Company issued 134,855 and 126,471 shares of common stock to employees related to the 2014 ESPP. The fair value of the purchase rights granted under the 2014 ESPP for each of the two year offering periods beginning May 20, 2016, November 20, 2016 and May 20, 2017 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, 2017 Fair value of common stock $ – $ Grant price $ – $ Expected term (in years) – Expected volatility % – % Risk-free interest rate % – % Expected dividend rate % Fair Value of Common Stock — The fair market value of the Company’s common stock on the first day of each offering period, or $3.79, $4.82 and $6.54 for the offering periods commencing May 20, 2016, November 20, 2016 and May 20, 2017. Grant Price — 85% of the fair market value of the Company’s common stock on the first day of each two year offering period, or $3.22, $4.10 and $5.56 for the offering periods commencing May 20, 2016, November 20, 2016 and May 20, 2017. 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, 2017 and 2016 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, 2017 2016 2017 2016 Cost of product revenues $ 93 $ 92 $ 300 $ 255 Cost of contract research and development revenues 61 54 169 146 Research and development 174 177 501 517 General and administrative 592 569 1,741 1,622 Total stock-based compensation $ 920 $ 892 $ 2,711 $ 2,540 As of June 30, 2017, there was a total of $5.3 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 2.3 years. |
Product Recall Liability
Product Recall Liability | 9 Months Ended |
Jun. 30, 2017 | |
Product Recall Liability | |
Product Recall Liability | 10. Product Recall Liability In fiscal 2008 and fiscal 2010, Allergan, plc, formerly known as Actavis, Inc. (“Actavis”) issued two voluntary recalls of certain lots and strengths of Fentanyl TDS manufactured by the Company and sold and distributed at that time by Actavis in the United States. The Company and Actavis negotiated financial settlements for these two recalls, and the Company accrued amounts related to these settlements in fiscal 2009 and 2011. These recall liabilities were subsequently reduced through various mechanisms per the terms of the settlement agreements. In October 2012, the Company reached a revised settlement related to the two recalls, which provided for a total and combined remaining liability of $5.0 million as of the settlement date. The revised liability will be repaid through quarterly payments in arrears based on a percentage of the average of the total net revenues recorded by the Company in those prior periods related to Fentanyl TDS, 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, 2017, the Company made settlement payments to Actavis of $0.1 million and $0.3 million compared to $0.2 million and $0.6 million for the corresponding periods in 2016. The outstanding balance of the recall liability was $2.0 million and $2.3 million as of June 30, 2017 and September 30, 2016. |
Net Loss and Net Loss per Share
Net Loss and Net Loss per Share Attributable to Common Stockholders | 9 Months Ended |
Jun. 30, 2017 | |
Net Loss and Net Loss per Share Attributable to Common Stockholders | |
Net Loss and Net Loss per Share Attributable to Common Stockholders | 11. Net Loss and Net Loss per Share Attributable to Common Stockholders The following table sets forth the computation of the Company's basic and diluted net loss per share attributable to common stockholders during the three months ended June 30, 2017 and 2016 (in thousands, except share and per share data): Three Months Ended Nine Months Ended June 30, June 30, 2017 2016 2017 2016 Basic and diluted net loss per share Net loss attributable to common stockholders, basic and diluted $ (13,384) $ (7,492) $ (34,850) $ (27,376) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 31,457,702 22,321,581 26,784,678 22,254,849 Net loss per share attributable to common stockholders, basic and diluted $ (0.43) $ (0.34) $ (1.30) $ (1.23) The following shares of common stock equivalents outstanding at the end of each period 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, 2017 2016 2017 2016 Stock options to purchase common stock 4,058,134 3,375,820 4,058,134 3,375,820 Unvested restricted stock unit awards 102,500 30,000 102,500 30,000 Shares authorized under the 2014 ESPP 636,399 503,689 636,399 503,689 Common stock warrants 51,386 51,386 51,386 51,386 |
Income Taxes
Income Taxes | 9 Months Ended |
Jun. 30, 2017 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The Company did not record a provision for Federal income taxes for the nine months ended June 30, 2017 because it expects to generate a net operating loss for the year ending September 30, 2017. The income tax expense of $2,000 and $3,000 for the nine months ended June 30, 2017 and 2016 represents minimum statutory payments due in the states in which the Company is subject to taxation. The Company’s deferred tax assets continue to be fully offset by a valuation allowance. |
Segment and Enterprise-Wide Inf
Segment and Enterprise-Wide Information | 9 Months Ended |
Jun. 30, 2017 | |
Segment and Enterprise-Wide Information | |
Segment and Enterprise-Wide Information | 13. 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, 2017 | |
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, 2017, statements of operations and comprehensive loss for the three and nine months ended June 30, 2017 and 2016, statement of stockholders’ equity for the nine months ended June 30, 2017, and statements of cash flows for the nine months ended June 30, 2017 and 2016 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, 2017, its results of operations for the three and nine months ended June 30, 2017 and 2016, and its cash flows for the nine months ended June 30, 2017 and 2016. 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, 2017 are not necessarily indicative of the results to be expected for the year ending September 30, 2017 or for any future annual or interim period. The balance sheet as of September 30, 2016 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, 2016 included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on December 20, 2016. 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, 2016. |
Liquidity | Liquidity With the exception of fiscal 2013, the Company has incurred losses from operations since fiscal 2006 and has an accumulated deficit of $202.3 million as of June 30, 2017. The Company has financed its operations primarily through the proceeds from the sale of equity securities, and various debt and capital lease financings. The Company believes that its existing cash and cash equivalents will not be sufficient to fund operations in compliance with its debt covenants as currently planned through the next 12 months, which raises substantial doubt about the Company’s ability to continue as a going concern. The Company has based this belief on assumptions and estimates that may prove to be wrong, and the Company could spend its available financial resources less or more rapidly than currently expected. The Company will continue to require additional sources of cash to develop product candidates and to fund development and commercialization operations. Management intends to seek additional capital through collaborative or other funding arrangements with partners, equity and/or debt financings, or through other sources of financing. The Company is also pursuing alternatives to its current debt covenants, including refinancing the existing debt. In the event that additional financing is required from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may be required to significantly delay, scale back or discontinue one or more of the product development programs or commercialization efforts or other aspects of the Company’s business plans, and its business, operating results and financial condition would be adversely affected. The Company is currently in compliance with the covenants under the Company’s term loan agreement with CRG, a structured debt and equity investment management firm. However, the Company anticipates that, based on its current operating plan for products and services currently under contract, and without securing additional sources of external funding, its current cash and cash equivalent balances will not be sufficient to maintain compliance with the minimum liquidity financial covenant through the next 12 months or the minimum annual revenue covenant of $50.0 million for the 12 months ending June 30, 2018. Failure to meet either covenant would be considered an event of default on the Company’s debt obligation, and could result in the acceleration of the Company’s existing indebtedness, causing the outstanding principal of approximately $52.5 million, plus an early prepayment premium and an additional fee, to be immediately due and payable to CRG. As of June 30, 2017, the prepayment premium was 7.5% and the additional fee was 1.0%. The Company may not have sufficient cash and cash equivalents to repay all of the outstanding debt in full if repayment of such debt were accelerated. Due to these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed financial statements as of June 30, 2017 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to secure new sources of revenue, obtain additional equity and/or debt financing or refinancing, generate operating efficiencies, reduce expenditures and amend or obtain a waiver on the financial covenants of the existing term loan agreement with CRG. The unaudited condensed financial statements as of June 30, 2017 do not include any adjustments that might result from the outcome of this uncertainty. |
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 the three and nine months ended June 30, 2017, three partners accounted for 96% and 93% of the Company’s revenues and three partners accounted for 97% of accounts receivable as of June 30, 2017. For the three and nine months ended June 30, 2016, three partners accounted for 84% and 85% of the Company’s revenues. As of September 30, 2016, four partners accounted for 84% of accounts receivable. |
Restricted Cash | Restricted Cash The Company’s restricted cash consists solely of cash maintained in a separate deposit account used to secure a letter of credit issued by a bank to a former landlord pursuant to a terminated lease agreement. The Company has classified the restricted cash as noncurrent on the condensed balance sheet. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) For the three and nine months ended June 30, 2017 and 2016, 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. |
Reclassifications | Reclassifications The Company reclassified certain balances in the condensed statements of cash flows for prior periods to conform to current presentation. The reclassifications did not impact total cash flows from operating, investing or financing activities. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
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, 2017 Level I Level II Level III Total Financial Assets: Money market funds $ 67,664 $ — $ — $ 67,664 As of September 30, 2016 Level I Level II Level III Total Financial Assets: Money market funds $ 39,950 $ — $ — $ 39,950 |
Summary of the changes in the fair value of the Company's Level III financial liabilities, which are measured on a recurring basis | The following financial liabilities have carrying values that differ from their fair value as estimated by the Company based on market quotes for instruments with similar terms and remaining maturities (Level III valuation) (in thousands): As of June 30, 2017 Carrying Fair Value Value Difference Long-term debt $ 52,094 $ 52,971 $ 877 As of September 30, 2016 Carrying Fair Value Value Difference Long-term debt $ 51,043 $ 51,649 $ 606 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Inventories | |
Schedule of Inventories | Inventories consist of the following (in thousands): As of June 30, As of September 30, 2017 2016 Raw materials $ 1,430 $ 1,307 Work in process 366 411 Finished goods 725 706 Total inventories $ 2,521 $ 2,424 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Long-Term Debt. | |
Schedule of the entity's outstanding debt | Outstanding long-term debt consists of the following (dollars in thousands): As of June 30, As of September 30, 2017 2016 Term loan agreement expiring June 30, 2019, less unamortized issuance costs of $817 and $544 and unamortized discount of $31 and $43 as of June 30, 2017 and September 30, 2016. See terms of the agreement below. $ 51,654 $ 50,546 Notes payable to lessor for tenant improvements. The note calls for monthly payments of principal and interest of $3 at an interest rate of 7% and is due September 2017 9 34 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 431 463 Total 52,094 51,043 Less current portion 54 77 Long-term portion $ 52,040 $ 50,966 |
Collaboration and Partner Arr24
Collaboration and Partner Arrangements (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
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, 2017 2016 2017 2016 Mayne $ 2,207 $ — $ 4,411 $ — Teva — 2,708 — 5,504 Endo / Par — 1,853 363 5,445 P&G 4,406 4,392 12,519 10,294 Agile 1,154 767 4,014 2,182 Other 342 886 1,115 1,680 Total revenues $ 8,109 $ 10,606 $ 22,422 $ 25,105 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
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, 2016 3,307,504 $ 4.69 6.57 $ 5,538 Options granted 868,450 $ 4.54 Options exercised (98,625) $ 2.33 Options forfeited / cancelled (19,195) $ 7.00 Balance - June 30, 2017 4,058,134 $ 4.70 6.72 $ 12,074 Options exercisable - June 30, 2017 2,696,450 $ 4.16 5.71 $ 9,359 Options vested and expected to vest - June 30, 2017 3,926,337 $ 4.67 6.65 $ 11,794 |
Schedule of valuation assumptions used for stock options | Nine Months Ended June 30, 2017 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, 2016 30,000 $ 7.94 Granted 80,000 4.59 Vested and released (7,500) 7.94 Forfeited — — Nonvested - June 30, 2017 102,500 $ 5.33 |
Schedule of valuation assumptions used for ESPP | As of June 30, 2017 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 income (loss) | Employee stock-based compensation expense for the three and nine months ended June 30, 2017 and 2016 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, 2017 2016 2017 2016 Cost of product revenues $ 93 $ 92 $ 300 $ 255 Cost of contract research and development revenues 61 54 169 146 Research and development 174 177 501 517 General and administrative 592 569 1,741 1,622 Total stock-based compensation $ 920 $ 892 $ 2,711 $ 2,540 |
Net Loss and Net Loss per Sha26
Net Loss and Net Loss per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Jun. 30, 2017 | |
Net Loss and Net Loss per Share Attributable to Common Stockholders | |
Schedule of computation of the Company's basic and diluted net loss per share attributable to common stockholders | The following table sets forth the computation of the Company's basic and diluted net loss per share attributable to common stockholders during the three months ended June 30, 2017 and 2016 (in thousands, except share and per share data): Three Months Ended Nine Months Ended June 30, June 30, 2017 2016 2017 2016 Basic and diluted net loss per share Net loss attributable to common stockholders, basic and diluted $ (13,384) $ (7,492) $ (34,850) $ (27,376) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 31,457,702 22,321,581 26,784,678 22,254,849 Net loss per share attributable to common stockholders, basic and diluted $ (0.43) $ (0.34) $ (1.30) $ (1.23) |
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, 2017 2016 2017 2016 Stock options to purchase common stock 4,058,134 3,375,820 4,058,134 3,375,820 Unvested restricted stock unit awards 102,500 30,000 102,500 30,000 Shares authorized under the 2014 ESPP 636,399 503,689 636,399 503,689 Common stock warrants 51,386 51,386 51,386 51,386 |
Organization, Description of 27
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, 2017USD ($)item | Jun. 30, 2016item | Jun. 30, 2017USD ($)item | Jun. 30, 2016item | Jun. 30, 2018USD ($) | Sep. 30, 2016USD ($)item | Dec. 31, 2016 | |
Liquidity | |||||||
Accumulated deficit | $ | $ (202,338) | $ (202,338) | $ (167,488) | ||||
Prepayment premium on long term debt (as a percent) | 7.50% | 7.50% | |||||
Percentage fee (as a percent) | 1.00% | 1.00% | |||||
Forecast | |||||||
Liquidity | |||||||
Minimum annual revenue covenant amount | $ | $ 50,000 | ||||||
Term loan agreement expiring on June 30, 2019 | |||||||
Liquidity | |||||||
Percentage fee (as a percent) | 1.00% | ||||||
Principal amount outstanding | $ | $ 52,500 | $ 52,500 | |||||
Revenues. | Customer concentration | Three partners | |||||||
Concentration of credit risk | |||||||
Number of partners | item | 3 | 3 | 3 | 3 | |||
Concentration risk percentage | 96.00% | 84.00% | 93.00% | 85.00% | |||
Accounts receivable | Credit concentration | Three partners | |||||||
Concentration of credit risk | |||||||
Number of partners | item | 3 | ||||||
Concentration risk percentage | 97.00% | ||||||
Accounts receivable | Credit concentration | Four partners | |||||||
Concentration of credit risk | |||||||
Number of partners | item | 4 | ||||||
Concentration risk percentage | 84.00% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring basis - Money market funds - USD ($) $ in Thousands | Jun. 30, 2017 | Sep. 30, 2016 |
Financial Assets | ||
Total financial assets | $ 67,664 | $ 39,950 |
Level I | ||
Financial Assets | ||
Total financial assets | $ 67,664 | $ 39,950 |
Fair Value Measurements (Level
Fair Value Measurements (Level III Valuation) (Details) - Level III - USD ($) $ in Thousands | Jun. 30, 2017 | Sep. 30, 2016 |
Carrying Value | ||
Fair value measurements | ||
Long-term debt | $ 52,094 | $ 51,043 |
Fair Value | ||
Fair value measurements | ||
Long-term debt | 52,971 | 51,649 |
Difference | ||
Fair value measurements | ||
Long-term debt | $ 877 | $ 606 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Sep. 30, 2016 |
Inventories | ||
Raw materials | $ 1,430 | $ 1,307 |
Work in process | 366 | 411 |
Finished goods | 725 | 706 |
Total inventories | $ 2,521 | $ 2,424 |
Long-Term Debt - Outstanding (D
Long-Term Debt - Outstanding (Details) | Dec. 04, 2014USD ($) | Nov. 14, 2014USD ($) | Dec. 31, 2012USD ($) | Aug. 31, 2012USD ($) | Jun. 30, 2017USD ($)installment | Sep. 30, 2016USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2017USD ($)installment | Dec. 31, 2016 | Jul. 13, 2012USD ($) |
Long-term Debt | ||||||||||
Carrying value of long-term debt | $ 52,094,000 | $ 51,043,000 | $ 51,043,000 | $ 52,094,000 | ||||||
Less current portion | 54,000 | 77,000 | 77,000 | 54,000 | ||||||
Long-term debt, net of current portion | $ 52,040,000 | 50,966,000 | 50,966,000 | $ 52,040,000 | ||||||
Percentage fee (as a percent) | 1.00% | 1.00% | ||||||||
Term loan agreement expiring on June 30, 2019 | ||||||||||
Long-term Debt | ||||||||||
Carrying value of long-term debt | $ 51,654,000 | 50,546,000 | 50,546,000 | $ 51,654,000 | ||||||
Unamortized issuance costs | 817,000 | 544,000 | 544,000 | 817,000 | ||||||
Unamortized discount | $ 31,000 | 43,000 | 43,000 | $ 31,000 | ||||||
Interest rate (as a percent) | 15.00% | 15.00% | ||||||||
Face amount | $ 45,000,000 | $ 35,000,000 | ||||||||
Increase in principal amount | $ 10,000,000 | |||||||||
Amount drawn | $ 6,000,000 | $ 29,000,000 | ||||||||
Proceeds from issuance of long-term debt | $ 10,000,000 | |||||||||
Number of quarterly installments for repayment of outstanding principal | installment | 4 | 4 | ||||||||
Percentage of cash payment the entity can defer by converting interest due into additional notes | 3.50% | |||||||||
Principal amount outstanding | $ 52,500,000 | $ 52,500,000 | ||||||||
Percentage fee (as a percent) | 1.00% | |||||||||
Anticipated loan fee | 500,000 | 500,000 | ||||||||
Notes payable due April 2017 | ||||||||||
Long-term Debt | ||||||||||
Carrying value of long-term debt | 9,000 | 34,000 | $ 34,000 | $ 9,000 | ||||||
Monthly payments of principal and interest | $ 3,000 | $ 3,000 | ||||||||
Interest rate (as a percent) | 7.00% | 7.00% | 7.00% | 7.00% | ||||||
Notes payable due in November 2024 | ||||||||||
Long-term Debt | ||||||||||
Carrying value of long-term debt | $ 431,000 | $ 463,000 | $ 463,000 | $ 431,000 | ||||||
Monthly payments of principal and interest | $ 6,000 | $ 6,000 | ||||||||
Interest rate (as a percent) | 7.00% | 7.00% | 7.00% | 7.00% | ||||||
Pik notes | ||||||||||
Long-term Debt | ||||||||||
Portion of interest due converted into additional notes | $ 6,100,000 | $ 7,500,000 |
Contingencies (Details)
Contingencies (Details) - LBA Realty Fund III Company VII LLC - USD ($) $ in Millions | Sep. 23, 2016 | Jun. 30, 2017 |
Litigation | ||
Loss contingency accrual | $ 0 | |
Minimum | ||
Litigation | ||
Damages sought | $ 10 |
Collaboration and Partner Arr33
Collaboration and Partner Arrangements (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Collaboration and partner arrangements | ||||
Total revenues | $ 8,109 | $ 10,606 | $ 22,422 | $ 25,105 |
Royalties and profit sharing | 100 | 500 | 700 | 1,700 |
Mayne | ||||
Collaboration and partner arrangements | ||||
Total revenues | 2,207 | 4,411 | ||
Teva | ||||
Collaboration and partner arrangements | ||||
Total revenues | 2,708 | 5,504 | ||
Endo/Par | ||||
Collaboration and partner arrangements | ||||
Total revenues | 1,853 | 363 | 5,445 | |
P&G | ||||
Collaboration and partner arrangements | ||||
Total revenues | 4,406 | 4,392 | 12,519 | 10,294 |
Agile | ||||
Collaboration and partner arrangements | ||||
Total revenues | 1,154 | 767 | 4,014 | 2,182 |
Other | ||||
Collaboration and partner arrangements | ||||
Total revenues | $ 342 | $ 886 | $ 1,115 | $ 1,680 |
Warrants (Details)
Warrants (Details) - Common stock warrants - $ / shares | 9 Months Ended | |
Jun. 30, 2017 | Sep. 30, 2016 | |
Warrants | ||
Warrants outstanding (in shares) | 51,386 | 51,386 |
Weighted-average exercise price (in dollars per share) | $ 9.26 | $ 9.26 |
Maximum | ||
Warrants | ||
Warrant term | 10 years |
Convertible Preferred Stock, 35
Convertible Preferred Stock, Common Stock and Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 07, 2017 | May 31, 2017 | Dec. 31, 2015 | Jun. 30, 2017 | Sep. 30, 2016 |
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 | |||||
Shares sold | 6,666,667 | 6,440,000 | 35,739,278 | 22,391,631 | |
Price of shares sold ( in dollars per share) | $ 3 | $ 6.25 | |||
Proceeds from issuance of common stock, net of issuance costs | $ 18,500 | $ 37,600 | $ 56,136 | ||
Underwriting discounts, commissions and issuance costs | $ 1,500 | $ 2,600 | |||
Common shares par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Common stock, shares outstanding | 35,739,278 | 22,391,631 | |||
Cantor Fitzgerald | |||||
Common Stock | |||||
Shares sold | 0 | ||||
Common shares par value (in dollars per share) | $ 0.001 | ||||
Aggregate proceeds amount authorized from Controlled Equity Offering Sales Agreement | $ 20,000 | ||||
Shares sold, commission percentage | 3.00% | ||||
Underwriters' Option | |||||
Common Stock | |||||
Shares sold | 840,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options (Details) $ / shares in Units, $ in Thousands | Jan. 10, 2017shares | Jan. 11, 2016shares | Mar. 19, 2014shares | Jun. 30, 2017USD ($)plan$ / sharesshares | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)plan$ / sharesshares | Jun. 30, 2016USD ($) | Sep. 30, 2016USD ($)plan$ / sharesshares |
Stock-Based Compensation | ||||||||
Number of plans | plan | 3 | 3 | 3 | |||||
Allocated Share-based Compensation Expense | $ | $ 920 | $ 892 | $ 2,711 | $ 2,540 | ||||
Stock options | ||||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Risk-free interest rate, minimum | 2.00% | |||||||
Risk-free interest rate, maximum | 2.31% | |||||||
Expected volatility, minimum | 76.00% | |||||||
Expected volatility, maximum | 79.00% | |||||||
Expected dividend rate (as a percent) | 0.00% | |||||||
Stock options | Minimum | ||||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Expected term (in years) | 5 years 3 months 7 days | |||||||
Stock options | Maximum | ||||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Expected term (in years) | 6 years 9 months 7 days | |||||||
2014 Plan | ||||||||
Stock-Based Compensation | ||||||||
Term of the plan | 10 years | |||||||
Number of shares of common stock reserved under plan for issuance to employees | 1,000,000 | |||||||
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 | 902,298 | 888,776 | ||||||
Corium Plans | ||||||||
Stock-Based Compensation | ||||||||
Number of shares of common stock reserved under plan for issuance to employees | 5,326,153 | 5,326,153 | 4,529,980 | |||||
Shares of common stock available for grant | 1,165,519 | 1,165,519 | 1,192,476 | |||||
Corium Plans | Stock options | ||||||||
Stock-Based Compensation | ||||||||
Vesting period | 4 years | |||||||
Stock Options Outstanding | ||||||||
Balance at the beginning of the period (in shares) | 3,307,504 | |||||||
Granted (in shares) | 868,450 | |||||||
Options exercised (in shares) | (98,625) | |||||||
Options forfeited / cancelled (in shares) | (19,195) | |||||||
Balance at the end of the period (in shares) | 4,058,134 | 4,058,134 | 3,307,504 | |||||
Options exercisable at the end of the period (in shares) | 2,696,450 | 2,696,450 | ||||||
Options vested and expected to vest at the end of the period (in shares) | 3,926,337 | 3,926,337 | ||||||
Weighted Average Exercise Price | ||||||||
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 4.69 | |||||||
Options granted (in dollars per share) | $ / shares | 4.54 | |||||||
Options exercised (in dollars per share) | $ / shares | 2.33 | |||||||
Options forfeited / cancelled (in dollars per share) | $ / shares | 7 | |||||||
Balance at the end of the period (in dollars per share) | $ / shares | $ 4.70 | 4.70 | $ 4.69 | |||||
Options exercisable at the end of the period (in dollars per share) | $ / shares | 4.16 | 4.16 | ||||||
Options vested and expected to vest at the end of the period (in dollars per share) | $ / shares | $ 4.67 | $ 4.67 | ||||||
Weighted Average Remaining Contractual Life | ||||||||
Balance | 6 years 8 months 19 days | |||||||
Balance | 6 years 6 months 26 days | |||||||
Options exercisable at the end of the period | 5 years 8 months 16 days | |||||||
Options vested and expected to vest at the end of the period | 6 years 7 months 24 days | |||||||
Aggregate Intrinsic Value | ||||||||
Balance at the beginning of the period | $ | $ 5,538 | |||||||
Balance at the end of the period | $ | $ 12,074 | 12,074 | $ 5,538 | |||||
Options exercisable at the end of the period | $ | 9,359 | 9,359 | ||||||
Options vested and expected to vest at the end of the period | $ | $ 11,794 | $ 11,794 | ||||||
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 | 9 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Stock-Based Compensation | |
Vesting period | 4 years |
Maximum | |
Stock-Based Compensation | |
Term of the plan | 10 years |
Corium Plans | |
Number of Shares | |
Nonvested at the beginning of the period (in shares) | shares | 30,000 |
Granted (in shares) | shares | 80,000 |
Vested and released (in shares) | shares | (7,500) |
Nonvested at the end of the period (in shares) | shares | 102,500 |
Weighted Average Grant Date Fair Value | |
Nonvested at the beginning of the period (in dollars per share) | $ / shares | $ 7.94 |
Granted (in dollars per share) | $ / shares | 4.59 |
Vested and released (in dollars per shares) | $ / shares | 7.94 |
Nonvested at the end of the period (in dollars per share) | $ / shares | $ 5.33 |
Stock-Based Compensation - 2014
Stock-Based Compensation - 2014 Employee Stock Purchase Plan (Details) | May 20, 2017$ / shares | Jan. 10, 2017shares | Nov. 20, 2016$ / shares | May 20, 2016$ / shares | Jan. 11, 2016shares | Mar. 19, 2014shares | Jun. 30, 2017USD ($)$ / sharesshares | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)$ / sharesshares | Jun. 30, 2016USD ($)shares | May 20, 2017item$ / shares | Sep. 30, 2016shares |
2014 Employee Stock Purchase Plan | ||||||||||||
Stock-based compensation | $ | $ 920,000 | $ 892,000 | $ 2,711,000 | $ 2,540,000 | ||||||||
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 | 636,399 | 636,399 | 503,689 | ||||||||
Stock-based compensation | $ | $ 60,000 | $ 79,000 | $ 224,000 | $ 217,000 | ||||||||
Additional shares authorized | shares | 267,565 | 257,631 | ||||||||||
Offering period | 2 years | 2 years | 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 | ||||||||||||
Fair value of common stock | $ 6.54 | $ 4.82 | $ 3.79 | $ 6.54 | ||||||||
Grant Price | $ 5.56 | $ 4.10 | $ 3.22 | |||||||||
Expected volatility, minimum | 70.00% | |||||||||||
Expected volatility, maximum | 98.00% | |||||||||||
Risk-free interest rate, minimum | 0.77% | |||||||||||
Risk-free interest rate, maximum | 1.28% | |||||||||||
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 | 134,855 | 126,471 | ||||||||||
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 | $ 3.79 | $ 3.79 | ||||||||||
Grant Price | $ 3.22 | |||||||||||
Expected term (in years) | 6 months | |||||||||||
2014 Employee Stock Purchase Plan | Maximum | ||||||||||||
Assumptions used in estimating weighted average fair value of the shares expected to be purchased | ||||||||||||
Fair value of common stock | $ 6.54 | $ 6.54 | ||||||||||
Grant Price | $ 5.56 | |||||||||||
Expected term (in years) | 2 years |
Stock-Based Compensation - St39
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Employee stock-based compensation expense | ||||
Stock-based compensation | $ 920 | $ 892 | $ 2,711 | $ 2,540 |
Additional Disclosure | ||||
Unrecognized employee compensation cost, net of estimated forfeitures | 5,300 | $ 5,300 | ||
Weighted-average period over which unrecognized compensation cost is expected to be recognized | 2 years 3 months 18 days | |||
Cost of product revenues | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 93 | 92 | $ 300 | 255 |
Cost of contract research and development revenues | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 61 | 54 | 169 | 146 |
Research and development | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 174 | 177 | 501 | 517 |
General and administrative | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | $ 592 | $ 569 | $ 1,741 | $ 1,622 |
Product Recall Liability (Detai
Product Recall Liability (Details) $ in Millions | 3 Months Ended | 9 Months Ended | 36 Months Ended | |||||
Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Sep. 30, 2011item | Sep. 30, 2010item | Sep. 30, 2016USD ($) | Oct. 31, 2012USD ($) | |
Product recall liability | ||||||||
Payment of settlement liability | $ | $ 0.1 | $ 0.2 | $ 0.3 | $ 0.6 | ||||
Recall liability | $ | $ 2 | $ 2 | $ 2.3 | $ 5 | ||||
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 Sha41
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, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
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 | $ (13,384) | $ (7,492) | $ (34,850) | $ (27,376) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 31,457,702 | 22,321,581 | 26,784,678 | 22,254,849 |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.43) | $ (0.34) | $ (1.30) | $ (1.23) |
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 | 4,058,134 | 3,375,820 | 4,058,134 | 3,375,820 |
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 | 102,500 | 30,000 | 102,500 | 30,000 |
Shares authorized under the 2014 ESPP | ||||
Anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | ||||
Number of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | 636,399 | 503,689 | 636,399 | 503,689 |
Common stock warrants | ||||
Anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | ||||
Number of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | 51,386 | 51,386 | 51,386 | 51,386 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Income Taxes | ||
Income tax expense | $ 2 | $ 3 |
Segment and Enterprise-Wide I43
Segment and Enterprise-Wide Information (Details) | 9 Months Ended |
Jun. 30, 2017item | |
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 |