Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2020 | Nov. 30, 2020 | Mar. 31, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Sep. 30, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | SRDX | ||
Security Exchange Name | NASDAQ | ||
Entity Registrant Name | Surmodics, Inc | ||
Entity Central Index Key | 0000924717 | ||
Current Fiscal Year End Date | --09-30 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Title of 12(b) Security | Common Stock, $0.05 par value | ||
Entity File Number | 0-23837 | ||
Entity Incorporation, State or Country Code | MN | ||
Entity Tax Identification Number | 41-1356149 | ||
Entity Address, Address Line One | 9924 West 74th Street | ||
Entity Address, City or Town | Eden Prairie | ||
Entity Address, State or Province | MN | ||
Entity Address, Postal Zip Code | 55344 | ||
City Area Code | 952 | ||
Local Phone Number | 500-7000 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Common Stock, Shares Outstanding | 13,676,110 | ||
Entity Public Float | $ 219 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 30,785 | $ 30,361 |
Available-for-sale securities | 30,313 | 24,931 |
Accounts receivable, net of allowances of $130 and $200 as of September 30, 2020 and 2019, respectively | 7,675 | 8,993 |
Contract assets — royalties and license fees | 6,108 | 8,210 |
Inventories, net | 5,966 | 4,501 |
Income tax receivable | 2,391 | 558 |
Prepaids and other | 3,370 | 3,866 |
Total Current Assets | 86,608 | 81,420 |
Property and equipment, net | 30,103 | 29,748 |
Deferred income taxes | 7,315 | 6,176 |
Intangible assets, net | 13,283 | 14,226 |
Goodwill | 27,185 | 26,171 |
Other assets | 4,269 | 2,124 |
Total Assets | 168,763 | 159,865 |
Current Liabilities: | ||
Accounts payable | 1,515 | 2,085 |
Accrued liabilities: | ||
Compensation | 6,630 | 4,581 |
Accrued other | 5,547 | 4,790 |
Deferred revenue | 5,200 | 5,553 |
Contingent consideration | 3,200 | |
Total Current Liabilities | 18,892 | 20,209 |
Deferred revenue, less current portion | 10,796 | 11,628 |
Other long-term liabilities | 8,020 | 5,512 |
Total Liabilities | 37,708 | 37,349 |
Commitments and Contingencies (Note 11) | ||
Stockholders’ Equity: | ||
Series A preferred stock — $.05 par value, 450 shares authorized; no shares issued and outstanding | ||
Common stock — $.05 par value, 45,000 shares authorized; 13,672 and 13,504 shares issued and outstanding, as of September 30, 2020 and 2019, respectively | 684 | 675 |
Additional paid-in capital | 15,369 | 10,740 |
Accumulated other comprehensive income | 3,174 | 396 |
Retained earnings | 111,828 | 110,705 |
Total Stockholders’ Equity | 131,055 | 122,516 |
Total Liabilities and Stockholders’ Equity | $ 168,763 | $ 159,865 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 |
Statement Of Financial Position [Abstract] | ||
Allowances (accounts receivable) | $ 130 | $ 200 |
Series A preferred stock, par value | $ 0.05 | $ 0.05 |
Series A preferred stock, shares authorized | 450,000 | 450,000 |
Series A preferred stock, shares issued | 0 | 0 |
Series A preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.05 | $ 0.05 |
Common stock, shares authorized | 45,000,000 | 45,000,000 |
Common stock, shares issued | 13,672,000 | 13,504,000 |
Common stock, shares outstanding | 13,672,000 | 13,504,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue: | |||
Total revenue | $ 94,864 | $ 100,077 | $ 81,336 |
Operating costs and expenses: | |||
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Product costs | $ 15,317 | $ 13,639 | $ 13,997 |
Research and development | 50,188 | 52,885 | 40,973 |
Selling, general and administrative | 28,392 | 23,950 | 24,111 |
Acquired in-process research and development | 890 | 7,888 | |
Acquired intangible asset amortization | 2,218 | 2,405 | 2,491 |
Contingent consideration (gain) expense | (161) | 675 | |
Total operating costs and expenses | 96,115 | 93,608 | 90,135 |
Operating (loss) income | (1,251) | 6,469 | (8,799) |
Other (expense) income: | |||
Investment income, net | 656 | 1,097 | 851 |
Interest expense | (133) | (152) | |
Foreign exchange (loss) gain | (248) | 134 | 239 |
(Loss) gain on strategic investments and other | (478) | 10 | 177 |
Other (expense) income | (203) | 1,089 | 1,267 |
(Loss) income before income taxes | (1,454) | 7,558 | (7,532) |
Income tax benefit | 2,577 | 34 | 3,075 |
Net income (loss) | $ 1,123 | $ 7,592 | $ (4,457) |
Basic net income (loss) per share: | $ 0.08 | $ 0.57 | $ (0.34) |
Diluted net income (loss) per share: | $ 0.08 | $ 0.55 | $ (0.34) |
Weighted average number of shares outstanding: | |||
Basic | 13,552 | 13,389 | 13,157 |
Diluted | 13,812 | 13,779 | 13,157 |
Product Sales [Member] | |||
Revenue: | |||
Total revenue | $ 44,317 | $ 40,219 | $ 37,953 |
Royalties and License Fees [Member] | |||
Revenue: | |||
Total revenue | 40,634 | 48,458 | 35,424 |
Research, Development and Other [Member] | |||
Revenue: | |||
Total revenue | $ 9,913 | $ 11,400 | $ 7,959 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net income (loss) | $ 1,123 | $ 7,592 | $ (4,457) |
Other comprehensive income (loss): | |||
Net changes related to available-for-sale securities, net of tax | (10) | 64 | (38) |
Foreign currency translation adjustments | 2,788 | (2,386) | (661) |
Other comprehensive income (loss) | 2,778 | (2,322) | (699) |
Comprehensive income (loss) | $ 3,901 | $ 5,270 | $ (5,156) |
Consolidated Statement of Share
Consolidated Statement of Shareholders' Equity - USD ($) $ in Thousands | Total | Revision of Prior Period Change in Accounting Principle Adjustment [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Retained Earnings [Member] | Retained Earnings [Member]Revision of Prior Period Change in Accounting Principle Adjustment [Member] |
Beginning balance at Sep. 30, 2017 | $ 111,557 | $ 655 | $ 5,413 | $ 3,417 | $ 102,072 | ||
Beginning balance, shares at Sep. 30, 2017 | 13,095,000 | ||||||
Net income (loss) | (4,457) | (4,457) | |||||
Other comprehensive income (loss), net of tax | (699) | (699) | |||||
Issuance of common stock | 340 | $ 7 | 333 | ||||
Issuance of common stock, shares | 137,000 | ||||||
Common stock options exercised, net | $ 1,749 | $ 22 | 1,727 | ||||
Common stock options exercised, net, shares | 450,000 | 440,000 | |||||
Purchase of common stock to pay employee taxes | $ (4,687) | $ (14) | (4,673) | ||||
Purchase of common stock to pay employee taxes, shares | (274,000) | ||||||
Stock-based compensation | 4,807 | 4,807 | |||||
Ending balance at Sep. 30, 2018 | 108,610 | $ 5,498 | $ 670 | 7,607 | 2,718 | 97,615 | $ 5,498 |
Ending balance, shares at Sep. 30, 2018 | 13,398,000 | ||||||
Accounting Standards Update [Extensible List] | us-gaap:AccountingStandardsUpdate201409Member | us-gaap:AccountingStandardsUpdate201409Member | |||||
Net income (loss) | 7,592 | 7,592 | |||||
Other comprehensive income (loss), net of tax | (2,322) | (2,322) | |||||
Issuance of common stock | 441 | $ 7 | 434 | ||||
Issuance of common stock, shares | 141,000 | ||||||
Common stock options exercised, net | $ 282 | $ 1 | 281 | ||||
Common stock options exercised, net, shares | 13,000 | 12,000 | |||||
Purchase of common stock to pay employee taxes | $ (2,662) | $ (3) | (2,659) | ||||
Purchase of common stock to pay employee taxes, shares | (47,000) | ||||||
Stock-based compensation | 5,077 | 5,077 | |||||
Ending balance at Sep. 30, 2019 | 122,516 | $ 675 | 10,740 | 396 | 110,705 | ||
Ending balance, shares at Sep. 30, 2019 | 13,504,000 | ||||||
Net income (loss) | 1,123 | 1,123 | |||||
Other comprehensive income (loss), net of tax | 2,778 | 2,778 | |||||
Issuance of common stock | 500 | $ 8 | 492 | ||||
Issuance of common stock, shares | 149,000 | ||||||
Common stock options exercised, net | $ 1,115 | $ 3 | 1,112 | ||||
Common stock options exercised, net, shares | 125,000 | 64,000 | |||||
Purchase of common stock to pay employee taxes | $ (2,430) | $ (2) | (2,428) | ||||
Purchase of common stock to pay employee taxes, shares | (45,000) | ||||||
Stock-based compensation | 5,453 | 5,453 | |||||
Ending balance at Sep. 30, 2020 | $ 131,055 | $ 684 | $ 15,369 | $ 3,174 | $ 111,828 | ||
Ending balance, shares at Sep. 30, 2020 | 13,672,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | ||
Operating Activities: | ||||
Net income (loss) | $ 1,123 | $ 7,592 | $ (4,457) | |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||||
Depreciation and amortization | 7,263 | 7,312 | 6,431 | |
Stock-based compensation | 5,453 | 5,077 | 4,807 | |
Payment of contingent consideration obligations in excess of acquisition-date value | (608) | (2,041) | ||
Contingent consideration (gain) expense | (161) | 675 | ||
Acquired in-process research and development | 890 | 7,888 | ||
Deferred taxes | [1] | (1,139) | (1,088) | (2,277) |
Losses (gains) on strategic investments | 479 | (7) | (177) | |
Provision for bad debts | 73 | 160 | 85 | |
Noncash lease expense | 246 | |||
Impairment losses on intangible assets | 259 | |||
Unrealized foreign exchange gain | (148) | |||
Other | 5 | (9) | 45 | |
Change in operating assets and liabilities | ||||
Accounts receivable and contract asset | [1] | 3,461 | (1,630) | (1,773) |
Inventories | (1,377) | (543) | (513) | |
Prepaids and other | 410 | (2,131) | (1,584) | |
Accounts payable | (483) | (765) | 155 | |
Accrued liabilities | 1,847 | (2,187) | 5,086 | |
Income taxes | [1] | (1,558) | 822 | (842) |
Deferred revenue | [1] | (1,185) | (3,512) | 20,651 |
Net cash provided by operating activities | 14,010 | 8,038 | 34,052 | |
Investing Activities: | ||||
Purchases of property and equipment | (3,671) | (5,998) | (9,092) | |
Cash proceeds from sale of property and equipment | 10 | |||
Purchases of available-for-sale securities | (59,917) | (44,973) | (81,536) | |
Sales and maturities of available-for-sale securities | 54,522 | 61,458 | 71,951 | |
Acquisition of in-process research and development (Note 11) | (750) | (5,000) | ||
Cash received from strategic investments | 7 | 177 | ||
Net cash (used in) provided by investing activities | (9,066) | 9,754 | (23,500) | |
Financing Activities: | ||||
Issuance of common stock | 1,615 | 723 | 2,089 | |
Payments for taxes related to net share settlement of equity awards | (2,534) | (2,688) | (4,557) | |
Payment of deferred financing costs | (137) | |||
Payment of contingent consideration obligations | (2,592) | (9,064) | (925) | |
Payments for acquisition of in-process research and development (Note 11) | (1,000) | |||
Net cash used in financing activities | (4,648) | (11,029) | (3,393) | |
Effect of exchange rate changes on cash | 128 | (70) | (25) | |
Net change in cash and cash equivalents | 424 | 6,693 | 7,134 | |
Cash and Cash Equivalents: | ||||
Beginning of year | 30,361 | 23,668 | 16,534 | |
End of year | 30,785 | 30,361 | 23,668 | |
Supplemental Information: | ||||
Cash paid for income taxes | 30 | 193 | 914 | |
Noncash financing and investing activities: | ||||
Acquisition of property and equipment and intangible assets, net of refundable credits in other current assets and liabilities | 1,306 | 202 | 632 | |
Right-of-use assets and property and equipment obtained in exchange for new operating lease liabilities | $ 1,181 | |||
Acquisition of in-process research and development in other long-term liabilities | 140 | 2,888 | ||
Accrual of employee taxes on common stock exercises | $ 104 | 130 | ||
Acquisition of property and equipment in long-term deferred rent | $ 1,200 | |||
[1] | For the fiscal year ended September 30, 2018, amounts presented are net of impact from adoption of ASC Topic 606. |
Description
Description | 12 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Description | 1. Description Surmodics, Inc. and subsidiaries (“Surmodics,” the “Company,” “we,” “us,” “our” and other like terms) is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic (“IVD”) immunoassay tests and microarrays. Surmodics is pursuing development and commercialization of highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development, and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. Basis of Presentation The consolidated financial statements include all accounts and wholly-owned subsidiaries and have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”). All intercompany transactions have been eliminated. The Company operates on a fiscal year ending on September 30. The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Ultimate results could differ from those estimates. Certain reclassifications have been made to the prior year's consolidated financial statements to conform to the current year presentation. Risk and Uncertainties The COVID-19 pandemic is having, and will likely continue to have, an adverse effect on our business, results of operations, financial condition, and cash flows, and its future impacts remain highly uncertain and unpredictable. The Company has considered the disruptions caused by COVID-19, including lower than forecasted sales and customer demand and macroeconomic factors, that may impact its estimates. The Company has assessed the potential impact of the pandemic on certain accounting matters including, but not limited to, estimated sales-based royalties revenue; allowance for doubtful accounts; inventory reserves; and the valuation of goodwill, intangible assets, other long-lived assets and investments, as of September 30, 2020 and through the date of this Annual Report on Form 10-K. As of the date of issuance of these consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company's financial condition, liquidity or results of operations is uncertain. For further information, refer to “Risk Factors” in Part II, Item 1A of this Annual Report on Form 10-K. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Select Balance Sheet Information | 12 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Select Balance Sheet Information | 2. Summary of Significant Accounting Policies and Select Balance Sheet Information Cash and Cash Equivalents Cash and cash equivalents consist of financial instruments with maturities of three months or less at the Company’s acquisition date of the security and are stated at cost which approximates fair value and may include money market instruments, certificates of deposit, repurchase agreements and commercial paper instruments. Accounts Receivable, Net We grant credit to customers in the normal course of business and maintain an allowance for doubtful accounts which reflects our estimate of uncollectible accounts as of the balance sheet date. We consider various factors in establishing, monitoring, and adjusting the allowance for credit losses including the aging of the accounts and aging trends, the historical level of charge-offs, and specific exposures related to particular customers. Investments Investments consisted of commercial paper and corporate bond securities and are classified as available-for-sale as of September 30, 2020 and 2019. Available-for-sale debt securities are reported at fair value with unrealized gains and losses, net of tax, excluded from the consolidated statements of operations and reported in the consolidated statements of comprehensive income (loss) and as a separate component of stockholders’ equity in the consolidated balance sheets, except for other-than-temporary impairments, which are reported as a charge to current earnings as they occur. A loss would be recognized when there is an other-than-temporary impairment in the fair value of any individual security classified as available-for-sale, with the associated net unrealized loss reclassified out of accumulated other comprehensive income with a corresponding adjustment to other (expense) income. This adjustment would result in a new cost basis for the investment. No such adjustments occurred during fiscal 2020, 2019 or 2018. Interest earned on debt securities, including amortization of premiums and accretion of discounts, is included in other (expense) income. Realized gains and losses from the sales of available-for-sale debt securities, which are included in other (expense) income, are determined using the specific identification method. The amortized cost, unrealized holding gains and losses, and fair value of available-for-sale securities were as follows: September 30, 2020 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 30,313 $ 19 $ (19 ) $ 30,313 Total $ 30,313 $ 19 $ (19 ) $ 30,313 September 30, 2019 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 24,918 $ 13 $ — $ 24,931 Total $ 24,918 $ 13 $ — $ 24,931 There were no held-to-maturity debt securities as of September 30, 2020 or 2019. There were no realized gains or losses on sales of available-for-sale securities for fiscal 2020, 2019 or 2018. Inventories Inventories are principally stated at the lower of cost or market using the specific identification method and include direct labor, materials and overhead, with cost of product sales determined on a first-in, first-out basis. Inventories consisted of the following components: September 30, (In thousands) 2020 2019 Raw materials $ 3,758 $ 2,034 Work-in process 817 892 Finished products 1,391 1,575 Total $ 5,966 $ 4,501 Property and Equipment Property and equipment are stated at cost, less any impairment, and are depreciated using the straight-line method over the estimated useful lives of the assets. The Company recorded depreciation expense of $4.8 million, $4.7 million and $3.7 million in fiscal 2020, 2019 and 2018, respectively. The September 30, 2020 and 2019 balances in construction-in-progress include the cost of equipment and building improvements not yet placed in service in the Company’s Ballinasloe, Ireland and Eden Prairie, Minnesota facilities. As assets are placed in service, construction-in-progress is transferred to the specific property and equipment categories and depreciated over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the term of the lease or the estimated useful life of the asset. Expenditures for maintenance and repairs and minor renewals and betterments that do not extend or improve the life of the respective assets are expensed as incurred. Property and equipment consisted of the following components: Useful Life September 30, (Dollars in thousands) (Years) 2020 2019 Land N/A $ 4,419 $ 4,415 Laboratory fixtures and equipment 3 to 12 28,600 25,467 Buildings and improvements 3 to 20 25,638 24,513 Leasehold improvements 3 to 10 4,836 4,836 Office furniture and equipment 3 to 10 7,334 6,476 Construction-in-progress 2,238 2,030 Less: Accumulated depreciation (42,962 ) (37,989 ) Property and equipment, net $ 30,103 $ 29,748 Other Assets Other assets consisted of the following: September 30, (In thousands) 2020 2019 ViaCyte, Inc. $ — $ 479 Operating lease right-of-use assets 2,508 — Other noncurrent assets 1,761 1,645 Other assets, net $ 4,269 $ 2,124 The Company has invested a total of $5.3 million in ViaCyte, Inc. (“ViaCyte”), a privately-held California-based biotechnology firm that is developing a treatment for diabetes using coated islet cells, the cells that produce insulin in the human body. As of September 30, 2019, the balance of the investment of $0.5 million, which was net of previously recorded other-than-temporary impairments of $4.8 million, was accounted for under the cost method and represented less than a 1% ownership interest. The Company does not exert significant influence over ViaCyte’s operating or financial activities. The total carrying value of cost method investments is reviewed quarterly for changes in circumstances or the occurrence of events that suggest the Company’s investment may not be recoverable. The carrying value of cost method investments is not adjusted if there are no identified events or changes in circumstances that may have a material adverse effect on the fair value of the investment. In fiscal 2020, the Company recorded a $0.5 million other-than-temporary impairment loss based on a ViaCyte financing transaction during the period and market valuations to reduce the carrying value of the investment in ViaCyte to zero. The valuation methodology for determining the decline in value of the ViaCyte investment was based on Level 3 inputs that required management judgment (Note 5). Operating lease right-of-use assets as of September 30, 2020 are recorded in accordance with ASC Topic 842, which we adopted as of October 1, 2019. Other noncurrent assets include a receivable related to refundable Irish research and development tax credits and prepaid expenses related to our ongoing clinical trials. Intangible Assets Intangible assets consisted of the following: September 30, 2020 (Dollars in thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 18,213 $ (12,451 ) $ 5,762 Developed technology 11.5 9,685 (4,200 ) 5,485 Non-compete 5.0 230 (230 ) — Patents and other 14.7 3,321 (1,865 ) 1,456 Total definite-lived intangible assets 31,449 (18,746 ) 12,703 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 32,029 $ (18,746 ) $ 13,283 September 30, 2019 (Dollars in thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 17,374 $ (10,661 ) $ 6,713 Developed technology 11.5 9,490 (3,196 ) 6,294 Non-compete 5.0 230 (196 ) 34 Patents and other 16.5 2,321 (1,716 ) 605 Total definite-lived intangible assets 29,415 (15,769 ) 13,646 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 29,995 $ (15,769 ) $ 14,226 The Company recorded amortization expense of $2.5 million, $2.6 million and $2.7 million in fiscal 2020, 2019 and 2018, respectively. Based on the intangible assets in service as of September 30, 2020, estimated amortization expense for each of the next five fiscal years is as follows: (In thousands) 2021 $ 2,488 2022 2,448 2023 1,843 2024 1,750 2025 1,712 Future amortization amounts presented above are estimates. Actual future amortization expense may be different as a result of future acquisitions, impairments, changes in amortization periods, foreign currency exchange rates or other factors. The Company defines in-process research and development (“IPR&D”) as the value of technology acquired for which the related projects have substance and are incomplete. IPR&D acquired in a business combination is recognized at fair value and is capitalized as an indefinite-lived intangible asset until completion or abandonment of the IPR&D project. Upon completion of the development project (generally when regulatory approval to market the product is obtained), an impairment assessment is performed prior to amortizing the asset over its estimated useful life. In cases where the IPR&D projects are abandoned, the related IPR&D assets are written off. The Company assesses indefinite-lived assets for impairment annually in the fourth quarter and whenever an event occurs or circumstances change that would indicate that the carrying amount may be impaired. Similar to the goodwill impairment assessment, the indefinite-lived assets impairment assessment requires the Company to make several estimates about fair value, most of which are based on projected future cash flows. The Company performs its annual assessment of indefinite-lived intangible assets for impairment as of July 1 st of each fiscal year. In fiscal 2020, the annual assessment date for impairment was changed to July 1 st from the August 31 st date used in fiscal 2019 and prior years. After completing the fiscal 20 19 impairment analys is , the fair value of certain IPR&D and trade name assets were deemed to be less than their carrying value, due to decreases in estimated future revenue associated with the assets. Accordingly, in fiscal 2019 , impairment losses on indefinite-lived intangible assets totaling $ 0.3 million were recorded in research and development expense in the consolidated statements of operations . No impairment charges were recorded in fiscal 2020 and 2018 as there were no indicators of impairment associated with indefinite-lived intangible assets. The valuation methodology for determining the decline in value of the indefinite-lived intangible assets in fiscal 2019 was based on Level 3 inputs that require management judgment (Note 5) . Goodwill Goodwill represents the excess of the purchase price of an acquired business over the fair value assigned to the assets purchased and liabilities assumed. Goodwill is not amortized but is subject, at a minimum, to annual tests for impairment in accordance with accounting guidance for goodwill. The carrying amount of goodwill is evaluated annually, and between annual evaluations if events occur or circumstances change indicating that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. The Company’s reporting units are the In Vitro Diagnostics and Medical Device operating segments. Inherent in the determination of fair value of the reporting units are certain estimates and judgments, including the interpretation of current economic indicators and market valuations, as well as the Company’s strategic plans with regard to its operations. The Company performs its annual assessment of goodwill for impairment as of July 1 st st st The impairment assessment is reliant on forecasted cash flows, as well as the selected discount rate when a quantitative assessment is necessary, which are inherently subjective and require significant management estimates. Differences in the reporting units’ actual future operating results compared to these forecasted estimates could materially affect the estimation of the fair value of the reporting units. Goodwill was not impaired in either reporting unit based on the outcome of the fiscal 2020 annual impairment test which utilized a quantitative assessment. Goodwill in the Medical Device reporting unit represents the gross value from the acquisitions of Creagh Medical, Ltd. (“Creagh Medical”) and NorMedix, Inc. (“NorMedix”), which were completed in fiscal 2016. Goodwill in the In Vitro Diagnostics reporting unit represents the gross value from the acquisition of BioFX Laboratories, Inc. in 2007. Changes in the carrying amount of goodwill by reportable segment were as follows: (In thousands) In Vitro Diagnostics Medical Device Total Balance as of September 30, 2018 $ 8,010 $ 19,022 $ 27,032 Foreign currency translation adjustment — (861 ) (861 ) Balance as of September 30, 2019 8,010 18,161 26,171 Foreign currency translation adjustment — 1,014 1,014 Balance as of September 30, 2020 $ 8,010 $ 19,175 $ 27,185 Valuation of Long-lived Assets The Company periodically evaluates whether events and circumstances have occurred that may affect the estimated useful life or the recoverability of the remaining balance of long-lived assets, such as property and equipment, right-of-use assets, and definite-lived intangible assets. If such events or circumstances were to indicate that the carrying amount of these assets may not be recoverable, the Company would estimate the future cash flows expected to result from the use of the assets and their eventual disposition. If the sum of the expected future cash flows (undiscounted and without interest charges) were less than the carrying amount of the assets, the Company would recognize an impairment charge to reduce such assets to their fair value. In fiscal 2020, 2019 and 2018, there were no impairment charges relating to the Company’s long-lived assets as there were no events or circumstances that occurred that affected the recoverability of such assets. Accrued Other Liabilities Accrued other liabilities consisted of the following: September 30, (In thousands) 2020 2019 Accrued professional fees $ 239 $ 434 Accrued clinical study expense 2,206 2,163 Accrued purchases 647 679 Acquisition of in-process research and development and intangible assets 1,148 989 Due to customers 321 19 Construction-in-progress 272 — Operating lease liability, current portion 436 — Deferred rent, current portion — 130 Other 278 376 Total accrued other liabilities $ 5,547 $ 4,790 Revenue Recognition Adoption of ASC Topic 606 in Fiscal 2019 Effective in fiscal 2019 (October 1, 2018), the Company adopted Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers The adoption of ASC Topic 606 in fiscal 2019 resulted in cumulative-effect adjustments to opening retained earnings, contract assets, deferred tax assets and income tax receivable as summarized below: (In thousands) September 30, 2018, As Reported Adjustments for Adoption of Topic 606 October 1, 2018 Opening Balance Assets Contract assets - royalties and license fees $ — $ 6,904 $ 6,904 Deferred income taxes 6,304 (1,215 ) 5,089 Income tax receivable 1,152 (390 ) 762 Liabilities and Stockholders' Equity Deferred revenue, current portion 9,646 (18 ) 9,628 Deferred revenue, less current portion 11,247 (181 ) 11,066 Retained earnings 97,615 5,498 103,113 The impact of adoption of ASC Topic 606 to the Company’s consolidated statements of operations for fiscal 2019 was an increase in royalties and license fee revenue of $1.3 million, as well as reduced income tax benefit of $0.3 million. Revenue is recognized when control of the promised goods or services is transferred to our customers in an amount that reflects the consideration we expect to be entitled to receive in exchange for those goods or services. The Company primarily sells or licenses its products, technologies and services to other medical device and diagnostics companies. Taxes collected from customers and remitted to governmental authorities that are imposed on, and concurrent with, a specific revenue producing transaction are excluded from revenue. For contracts that have an original duration of one year or less, the Company uses the practical expedient applicable to such contracts and does not adjust the transaction price for the time value of money. Performance Obligations We derive our revenue from three primary sources: • Product revenues from the sale of chemical components within our IVD segment, including stabilization products, substrates, surface coatings, and antigens to the diagnostic and biomedical research markets; the sale of reagent chemicals to licensees within our Medical Device segment; and the sale of medical devices and related products (such as balloons and catheters) to original equipment manufacturer (“OEM”) suppliers and distributors within our Medical Device segment; • Royalties and license fees from licensing our proprietary surface modification coating and medical device technologies to our medical device manufacturers within our Medical Device segment; and • Research and development fees generated from contract coating services within our Medical Device segment and new product development and testing within our Medical Device and IVD segments. The Company recognizes revenue when control is transferred to the customer. The transfer of control varies by revenue classification and is described below. Product Sales . Revenue from product sales is recognized at the point in time control of the products is transferred, generally upon shipment based upon the standard contract terms. Shipping and handling activities are considered to be fulfillment activities rather than promised services and are not, therefore, considered to be separate performance obligations. The Company’s sales terms provide no right of return outside of a standard warranty policy, and returns are generally not significant. Payment terms for product sales are generally set at 30-45 days after shipment Royalties . Royalties revenue consists of sales-based and recurring minimum royalties earned under licenses of our surface modification coating technologies. Performance obligations under these licenses, which consist of the right to use the Company’s proprietary technology, are satisfied at a point in time corresponding with delivery of the underlying technology rights to the customer, which is generally upon transfer of the licensed technology to the customer. Sales-based royalties revenue represents variable consideration under the license agreements and is recognized in the period a customer sells products incorporating the Company’s licensed technologies. The Company estimates sales-based royalties revenue earned but unpaid at each reporting period using the expected value method based on historical sales information, adjusted for known changes such as product launches and patent expirations. The Company also considers macroeconomic factors affecting the medical device market. The Company's license arrangements also often provide for recurring fees (minimum royalties), which the Company recognizes at the later of the satisfaction of the underlying performance obligation or upon renewal of the contract, which generally occurs on a quarterly basis. Sales-based and minimum royalties are generally due within 45 days after the end of each quarter. License Fees . For distinct license performance obligations, upfront license fees are recognized when the Company satisfies the underlying performance obligation. This generally occurs upon transfer of the right to use the Company’s licensed technology to the customer, with the exception of the license of the Company’s SurVeil™ drug-coated balloon (the “ DCB”) disclosed below. Certain license arrangements include contingent milestone payments, which are due following achievement by our customers of specified sales or regulatory milestones. Contingent milestone payment terms vary by contract. The Company has generally fulfilled its performance obligation prior to achievement of these milestones. However, because of the uncertainty of the milestone achievement, and/or the dependence on sales of our customers, variable consideration for contingent milestones is fully constrained and excluded from the contract price until the milestone is achieved by our customer, to the extent collectability is reasonably certain. The Company has a collaborative arrangement contract with Abbott Vascular, Inc. (“Abbott”) disclosed in Note 4 (the “Abbott Agreement”). Under the Abbott Agreement, the Company has received payments totaling $45.8 million, which consisted of the following: $25 million upfront fee in fiscal 2018, $10 million milestone payment in fiscal 2019 upon completion of enrollment in the TRANSCEND clinical trial, and $10.8 million milestone payment in fiscal 2020 upon receipt of Conformité Européenne Mark (“CE Mark”) approval prerequisite for commercialization of the SurVeil The Company consisting of: (i) $15 million upon successful completion of the clinical study report of the TRANSCEND pivotal trial demonstrating safety and clinical non-inferiority with the control device and (ii) $30 million upon premarket approval of our SurVeil DCB by the U.S. Food and Drug Administration (“FDA”). The performance obligation identified in this arrangement includes delivery of our licensed technology and completion of research and development activities, primarily clinical trial activities (together, “R&D and Clinical Activities”). These promises are not distinct performance obligations because the product necessary for completion of the R&D and Clinical Activities is currently only able to be manufactured by the Company due to the exclusive proprietary know-how and certain regulatory requirements associated with the manufacture of the product. SurVeil using the cost-to-cost method which measures progress based on costs incurred to date relative to the expected total cost of the services, as the Company believes this represents a faithful depiction of the satisfaction of its performance obligation. Revenue from the upfront fee and contingent clinical and regulatory milestone payments, once the underlying contingencies are achieved, is recognized within royalties and license fees in the consolidated statements of operations as the clinical and regulatory activities are performed on a proportional performance basis. Performance is measured based on actual costs incurred relative to the expected total cost of the underlying activities, most notably the completion of the TRANSCEND clinical trial. A significant component of the cost of this trial is the cost of the Company’s outsourced clinical trial clinical research organization (“CRO”) consultants, which is estimated based on executed statements of work, project budgets, and patient enrollment timing, among other factors. A significant change to the Company’s estimate of the costs to complete the TRANSCEND clinical trial could have a material effect on the Company’s results of operations. Significant judgment is used to estimate total revenue and cost at completion for this contract. To account for the Abbott Agreement, the Company applied the guidance in ASC Topic 808 (Collaborative Arrangements) as the parties are active participants and are exposed to significant risks and rewards dependent on commercial success of the collaborative activity. See Note 4 “Collaborative Arrangements” for further disclosures related to the Abbott Agreement. Research and Development . The Company performs research and development (“R&D”) activities as a service to customers, which are typically charged to customers on a time-and-materials basis. Generally, revenue for R&D services is recorded over time as the services are provided to the customer in the amount to which the Company has the right to invoice. These services are generally charged to the customer as they are provided. Payment terms for R&D services are generally set at 30-45 days. Contract Assets, Deferred Revenue and Remaining Performance Obligations Contract assets are generally short in duration given the nature of products produced and services provided by the Company. Contract assets consist of sales-based and minimum royalties revenue earned for which unconditional right to payment does not exist as of the balance sheet date. These assets are comprised of estimated sales-based royalties earned, but not yet reported by the Company’s customers, minimum royalties on non-cancellable contracts, and contingent milestones earned, but not yet billable based on the terms of the contract. The decrease in contract assets from September 30, 2019 to September 30, 2020 resulted primarily from changes in sales-based and minimum royalties earned, but not collected at each balance sheet date, notably due to the expiration of our fourth-generation hydrophilic coating patents in fiscal 2020 and the impact of COVID-19. The Company records a contract liability, or deferred revenue, when there is an obligation to provide a product or service to the customer, and payment is received or due in advance of performance, or when payment is received for a period outside the contract term. The Company’s deferred revenue as of September 30, 2020 and 2019 is primarily related to the upfront and milestone payments received pursuant to the Abbott Agreement (Note 4). Remaining performance obligations include deferred revenue and amounts the Company expects to receive for goods and services that have not yet been delivered or provided under existing, noncancellable contracts. For contracts that have an original duration of one year or less, the Company has elected the practical expedient applicable to such contracts and does not disclose the transaction price for remaining performance obligations at the end of each reporting period or the expecting timing of recognition of related revenue. As of September 30, 2020, the estimated revenue expected to be recognized in future periods totaled approximately $15.9 million related to performance obligations that are unsatisfied for executed contracts with an original duration of one year or more. This revenue is entirely related to the R &D and Clinical Activities performance obligation in the Abbott Agreement from the upfront payment and milestone payments and excludes revenue from potential contingent milestone payments that may be received in the future performance obligation Concentrations The Company has licenses and supply agreements with a diverse base of customers, and certain customers have multiple products using the Company’s technology. Abbott and its affiliates and Medtronic plc (“Medtronic”) are our largest customers, comprising 19% and 14%, respectively, of our consolidated revenue for both fiscal 2020 and 2019. These same customers each comprised 11% and 16%, respectively, of our consolidated revenue for fiscal 2018. Abbott has several separately licensed products, including the SurVeil DCB license, which generate royalties and license fee revenue for Surmodics. Revenue from the SurVeil DCB license represented 13%, 13% and 5% of total revenue for fiscal 2020, 2019 and 2018, respectively. Medtronic has several separately licensed products that generate royalties revenue for Surmodics, none of which represented more than 5% of our consolidated revenue for fiscal 2020 The Company’s licensing agreements with many of its customers, including most of its significant customers, cover many licensed products that each separately generates royalties revenue. This structure reduces the potential risk to the Company’s operations that may result from reduced sales (or the termination of a license) of a single product for any specific customer. The Company believes that the credit risk related to marketable securities is limited due to the adherence to an investment policy and that credit risk related to accounts receivable is limited due to a large customer base. Stock-based Compensation We measure the cost of employee services received in exchange for the award of equity instruments based on the fair value of the award at the date of grant. Share-based payments are expensed based on their grant-date fair values on a straight-line basis over the requisite service period of the total award, less estimated forfeitures based on historical experience. Shares awarded under the Company’s stock-based compensation plans, with the exception of restricted stock awards, are not considered issued or outstanding common stock of the Company until they vest and the shares are released. New awards and forfeitures of unvested restricted stock result in an increase (decrease), respectively, in common stock issued and outstanding. Income Taxes We record a tax benefit (provision) for the anticipated tax consequences of the reported results of operations. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is provided when it is more likely than not that some portion, or all, of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in this assessment. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in earnings in the period that includes the enactment date of such change. Research and Development R&D expenses include costs associated with the design, development, testing, enhancement and regulatory approval of the Company’s products. R&D expenses include employee compensation (including stock-based compensation), internal and external costs associated with our regulatory compliance and quality assurance functions, the costs of product used in development and clinical trials, consulting expenses, and facilities overhead. The Company also incurs significant R&D expenses to operate clinical trials. R&D costs are expensed as incurred. Certain R&D costs are related to customer contracts, and the related revenue is recognized as described in “Revenue Recognition” above. Costs associated with customer-related R&D include specific project direct labor and materials expenses, as well as an allocation of overhead costs based on direct labor costs. Clinical Trial Costs. The Company sponsors clinical trials intended to obtain the necessary clinical data required to obtain approval from various regulatory agencies to market medical devices developed by the Company. Costs associated with clinical trials include trial design and management expenses, clinical site reimbursements and third-party fees, among other costs. The Company’s clinical trials are administered by third-party CROs. These CROs generally bill monthly for certain services performed, as well as upon achievement of certain milestones. The Company monitors patient enrollment, the progress of clinical studies, and related activities through internal reviews of data reported to the Company by the CROs and correspondence with the CROs. We periodically evaluates our estimates to determine if adjustments are necessary or appropriate based on information received. These estimates often require significant judgement on the part of the Company’s management. Government Funding . The Company is eligible to receive reimbursement for certain qualifying R&D expenditures under a grant from the Industrial Development Agency of Ireland (“IDA”). Reimbursements are recognized as a reduction of R&D expense when there is reasonable assurance that the funding will be received and conditions associated with the funding are met. The Company recorded reimbursements from IDA grants of $0.8 million, $0.7 million and $0.8 million in fiscal 2020, 2019 and 2018, respectively, as a reduction of R&D expense. Net Income (Loss) Per Share Data Basic net income (loss) per common share is calculated by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted income per common share is computed by dividing net income by the weighted average number of common and common |
Revenue
Revenue | 12 Months Ended |
Sep. 30, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue | 3. Revenue The following table presents the Company’s revenues disaggregated by product classification and by reportable segment: Fiscal Year (In thousands) 2020 2019 2018 Medical Device Product sales $ 21,608 $ 18,617 $ 17,200 Royalties 28,614 34,781 30,606 License fees 12,020 13,678 4,818 Research, development and other 9,159 11,277 7,889 Total Revenue — Medical Device 71,401 78,353 60,513 In Vitro Diagnostics Product sales 22,709 21,390 20,789 Other 754 334 34 Total Revenue — In Vitro Diagnostics 23,463 21,724 20,823 Total Revenue $ 94,864 $ 100,077 $ 81,336 |
Collaborative Arrangement
Collaborative Arrangement | 12 Months Ended |
Sep. 30, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborative Arrangement | 4. Collaborative Arrangement On February 26, 2018, the Company entered into an agreement with Abbott whereby Abbott has exclusive worldwide commercialization rights for Surmodics' SurVeil TM SurVeil SurVeil SurVeil Under the Abbott Agreement, the Company has received payments totaling $45.8 million which consist of the following: $25 million upfront fee in fiscal 2018, $10 million milestone payment in fiscal 2019, and $10.8 million milestone payment in fiscal 2020. The Company may receive up to $45 million of additional contingent milestone payments, pursuant to the terms of the Abbott Agreement, consisting of: (i) $15 million upon successful completion of the clinical study report of the TRANSCEND pivotal trial demonstrating safety and clinical non-inferiority with the control device and (ii) $30 million upon premarket approval of our SurVeil Revenue recognized from the Abbott Agreement totaled $12.0 million, $13.5 million and $4.4 million in fiscal 2020, 2019 and 2018, respectively. As of September 30, 2020, the Company had recognized total license fee revenue of $29.9 million from the Abbott Agreement. Revenue recognized from the Abbott Agreement, which was included in the respective beginning of fiscal year balances of deferred revenue on the consolidated balance sheets, totaled $5.0 million and $8.4 million for fiscal 2020 and 2019, respectively. As of September 30, 2020 and 2019, deferred revenue from the upfront and milestone payments received of $15.9 million and $17.1 million, respectively, was recorded in the consolidated balance sheets. See Note 2 for further information regarding revenue recognition for the Abbott Agreement. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The accounting guidance on fair value measurements defines fair value, establishes a framework for measuring fair value under GAAP, and expands disclosures about fair value measurements. The guidance is applicable for all financial assets and financial liabilities and for all nonfinancial assets and nonfinancial liabilities recognized or disclosed at fair value in the consolidated financial statements on a recurring basis (at least annually). Fair value is defined as the exchange price that would be received from selling an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and also considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions and risk of nonperformance. Fair Value Hierarchy Assets and liabilities carried at fair value are classified and disclosed in one of the following three categories: Level 1 — Quoted (unadjusted) prices in active markets for identical assets or liabilities. Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active markets; 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 asset or liability. Level 3 — Unobservable inputs to the valuation methodology that are supported by little or no market activity and that are significant to the measurement of the fair value of the assets or liabilities. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques, as well as significant management judgment or estimation. In valuing Level 3 assets and liabilities, the Company is required to maximize the use of quoted market prices and minimize the use of unobservable inputs. In valuing assets and liabilities, the Company is required to maximize the use of quoted market prices and minimize the use of unobservable inputs. In instances where the inputs used to measure fair value fall into different levels of the fair value hierarchy, the fair value measurement has been determined based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular item to the fair value measurement in its entirety requires judgment, including the consideration of inputs specific to the asset or liability. The Company did not have any Level 1 assets as of September 30, 2020 or 2019. The Company’s Level 2 assets as of September 30, 2020 and 2019 consisted of cash equivalents (money market funds and commercial paper instruments) and available-for-sale debt securities (commercial paper instruments and corporate bonds). Cash equivalents are carried at historical cost which is a reasonable estimate of fair value because of the relatively short time between origination of the instrument and its expected realization. Available-for-sale securities are valued based on quoted vendor prices in active markets underlying the securities. Fair market values for cash equivalents and available-for-sale debt securities are based on quoted vendor prices and broker pricing where all significant inputs are observable. To ensure the accuracy of quoted vendor prices and broker pricing, the Company performs regular reviews of investment returns to industry benchmarks and sample tests of individual securities to validate quoted vendor prices with other available market data. The Company’s Level 3 liabilities consisted of contingent consideration liabilities arising from business and asset acquisitions as of September 30, 2019. The fair value of contingent consideration liabilities was determined based on discounted cash flow analyses that included revenue estimates, probability of strategic milestone achievement and a discount rate, which are considered significant unobservable inputs as of the acquisition dates and as of September 30, 2019. The Company did not significantly change its valuation techniques from prior periods. There were no transfers of assets or liabilities to or from amounts measured using Level 3 fair value measurements during fiscal 2020 or 2019. Assets and Liabilities Measured at Fair Value on a Recurring Basis Assets and liabilities measured at fair value on a recurring basis by level of the fair value hierarchy were as follows: September 30, 2020 (In thousands) Quoted Prices in Active Markets for Identical Instruments (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Fair Value Assets Cash equivalents $ — $ 18,634 $ — $ 18,634 Available-for-sale securities — 30,313 — $ 30,313 Total assets $ — $ 48,947 $ — $ 48,947 September 30, 2019 (In thousands) Quoted Prices in Active Markets for Identical Instruments (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Fair Value Assets Cash equivalents $ — $ 24,375 $ — $ 24,375 Available-for-sale securities — 24,931 — $ 24,931 Total assets $ — $ 49,306 $ — $ 49,306 Liabilities Contingent consideration $ — $ — $ 3,200 $ 3,200 Total liabilities $ — $ — $ 3,200 $ 3,200 Changes in the contingent consideration liabilities measured at fair value using Level 3 inputs were as follows: (In thousands) Contingent consideration liability at September 30, 2018 $ 14,466 Additions — Fair value adjustments (415 ) Settlements (10,979 ) Interest accretion 254 Foreign currency translation (126 ) Contingent consideration liability at September 30, 2019 3,200 Additions — Fair value adjustments — Settlements (3,200 ) Interest accretion — Foreign currency translation — Contingent consideration liability at September 30, 2020 $ — As of September 30, 2019, contingent consideration liabilities consisted of $3.2 million related to the fiscal 2016 acquisition of NorMedix which was paid in fiscal 2020. As of September 30, 2018, contingent consideration liabilities totaled $14.5 million, of which $3.4 million was noncurrent, and related to the fiscal 2016 acquisitions of Creagh Medical and NorMedix. The contingency period for the NorMedix acquisition ended September 30, 2019. Based on the milestones achieved during the contingency period, the Company paid the NorMedix shareholders $3.2 million in fiscal 2020. The contingency period for the Creagh Medical contingent consideration obligation ended September 30, 2018. Based on the milestones achieved during the contingency period, the Company paid Creagh Medical shareholders $11.0 million in fiscal 2019. The Creagh Medical obligation was discounted using the Company’s annualized cost of debt for the three-month period between September 30, 2019 and the expected settlement date, or 2.3%. Probability of completion for the redefined milestones was reflected in the estimated fair value of the NorMedix contingent consideration obligation as of September 30, 2018. For the revenue-based milestones, the Company discounted forecasted revenue by The €9.6 million (approximately $11.0 million September 30, 2018) $0.1 Assets and Liabilities Measured at Fair Value on a Non- r ecurring Basis We measure certain assets at fair value on a nonrecurring basis, primarily goodwill, intangible assets, and long-lived assets, as well as cost method equity investments recorded within other assets on the consolidated balance sheets. These assets were initially measured and recognized at amounts equal to the fair value determined as of the date of acquisition or purchase and subject to changes in value only for foreign currency translation and impairment. See Note 2 for additional information on impairment assessments and related Level 3 inputs for goodwill, indefinite-lived intangible assets, long-lived assets, and cost method equity investments. Assets and Liabilities Not Measured at Fair Value Certain financial instruments are not measured at fair value but are recorded at carrying amounts approximating fair value based on their short-term nature. The carrying value of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximated fair value as of September 30, 2020 and 2019. |
Debt
Debt | 12 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Debt | 6. Debt On September 14, 2020, the Company entered into a secured revolving credit facility pursuant to a Loan and Security Agreement (the "Loan Agreement") with Bridgewater Bank (the “Bank”). The Loan Agreement provides for availability under a secured revolving line of credit of up to $25 million (the "Loan"). The outstanding balance on the Loan was zero at September 30, 2020. Availability under the Loan is subject to a borrowing base that equals 80% of the margin value of securities collateral that has been pledged to the Bank. The Loan will initially mature on September 14, 2021, but the maturity date may be extended by the Company for up to two extension periods of twelve months subject to certain conditions set forth in the Loan Agreement. The Company's obligations under the Loan Agreement are secured by substantially all of the Company’s and its material subsidiaries' assets, other than intellectual property, real estate and foreign assets, including equity in foreign subsidiaries. The Company has also pledged the stock of certain of its subsidiaries to secure such obligations. Interest under the Loan Agreement accrues at a rate per annum equal to the greater of (i) 3.25% per annum and (ii) the 90-day interest rate yield for U.S. Government Treasury Securities plus 2.75% per annum. A facility fee is payable on unused commitments at a rate of 0.075% quarterly. The Loan Agreement contains affirmative and negative covenants customary for a transaction of this type which, among other things, require the Company to meet certain financial tests, including (i) minimum liquidity, (ii) minimum current ratio, (iii) minimum adjusted EBITDA, and (iv) minimum tangible net worth. The Loan Agreement also contains covenants which, among other things, limit the Company's ability to incur additional debt, make certain investments, create or permit certain liens, create or permit restrictions on the ability of subsidiaries to pay dividends or make other distributions, consolidate or merge and engage in other activities customarily restricted in such agreements, in each case subject to exceptions permitted by the Loan Agreement. The Loan Agreement also contains customary events of default, the occurrence of which would permit the Bank to terminate its commitment and accelerate the Loan. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Repurchase of Common Stock Shares are repurchased from time to time to support the Company’s stock-based compensation programs and to return capital to stockholders. The Company accounts for repurchases of common stock using the par value method. On November 6, 2015 and November 5, 2014, the Company’s Board of Directors authorized the repurchase of up to $20.0 million and $30.0 million, respectively, of the Company’s outstanding common stock in open-market purchases, privately negotiated transactions, block trades, accelerated share repurchase transactions, tender offers or by any combination of such methods. The authorizations have no fixed expiration date. As of September 30, 2020, million remained available to the Company for the purchase of its common stock under outstanding authorizations. |
Stock-based Compensation Plans
Stock-based Compensation Plans | 12 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation Plans | 8. Stock-based Compensation Plans The Company has stock-based compensation plans under which it grants stock options, restricted stock awards, restricted stock units and deferred stock units. Stock-based compensation expense was reported as follows in the consolidated statements of operations: Fiscal Year (In thousands) 2020 2019 2018 Product costs $ 119 $ 135 $ 69 Research and development 896 876 801 Selling, general and administrative 4,438 4,066 3,937 Total stock-based compensation expense $ 5,453 $ 5,077 $ 4,807 As of September 30, 2020, approximately $7.4 million of total unrecognized compensation costs related to non-vested awards is expected to be recognized over a weighted average period of approximately 2.2 years. Under the 2019 Equity Incentive Plan (“2019 Plan”), the Company is authorized to issue 1,100,000 shares, plus the number of shares pursuant to any awards granted under the 2009 Equity Incentive Plan (“2009 Plan”) that were outstanding on the effective date of the 2019 Plan that expire, are cancelled or forfeited, or are settled for cash. As of September 30, 2020, there were approximately 839,000 shares available for future equity awards under the 2019 Plan, including stock options, restricted stock, restricted stock units, and deferred stock units. Stock Option Awards The Company grants non-qualified stock options at fair market value on the grant date to certain key employees and members of the Board. The Company uses the Black-Scholes option pricing model to determine the fair value of stock options as of the date of each grant. Stock option fair value assumptions and the weighted average fair value of stock options granted were as follows: Fiscal Year 2020 2019 2018 Stock option fair value assumptions: Risk-free interest rates 1.41 % 2.75 % 2.18 % Expected life (years) 4.6 4.5 4.8 Expected volatility 39 % 34 % 33 % Dividend yield — % — % — % Weighted average grant date fair value of stock options granted $ 14.13 $ 17.89 $ 10.91 The risk-free interest rate assumption is based on the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the awards. The expected life of options granted is determined based on the Company’s experience. Expected volatility is based on the Company’s stock price movement over a period approximating the expected term. Based on management’s judgment, dividend yields are expected to be zero for the expected life of the options. With respect to members of the Board, non-qualified stock options generally become exercisable on a monthly pro-rata basis within the one-year As of September 30, 2020, the aggregate intrinsic value of the option shares outstanding and option shares exercisable was $6.8 million and $5.8 million, respectively. As of September 30, 2020, the weighted average remaining contractual life of options outstanding and options exercisable was 4.3 years and 3.2 years, respectively. The total pre-tax intrinsic value of options exercised was $2.0 million, $0.3 million and $12.1 million in fiscal 2020, 2019 and 2018, respectively. The intrinsic value represents the difference between the exercise price and the fair market value of the Company’s common stock on the last day of the respective fiscal year end. Stock option activity was as follows: (In thousands, except per share data) Number of Shares Weighted Average Exercise Price Options outstanding at September 30, 2017 1,002 $ 21.54 Granted 270 34.08 Exercised (450 ) 19.46 Forfeited and expired (111 ) 30.18 Options outstanding at September 30, 2018 711 26.28 Granted 179 55.09 Exercised (13 ) 22.03 Forfeited and expired (6 ) 42.28 Options outstanding at September 30, 2019 871 32.18 Granted 299 41.06 Exercised (125 ) 22.89 Forfeited and expired (105 ) 41.69 Options outstanding at September 30, 2020 940 35.18 Options vested and exercisable at September 30, 2020 472 $ 28.65 Restricted Stock Awards The Company has entered into restricted stock agreements with certain key employees, covering the issuance of common stock (“Restricted Stock”). Restricted Stock generally vests at a 33% rate on each of the first three anniversaries following the grant date. Restricted Stock is released to employees if they are employed by the Company at the end of the vesting period. Restricted Stock is valued based on the market value of the shares as of the date of grant with the value allocated to expense evenly over the vesting period. As of September 30, 2020 and 2019, the weighted average grant date fair value of outstanding, unvested Restricted Stock totaled $3.9 million and $4.0 million, respectively. The stock-based compensation table above includes Restricted Stock expenses recognized related to these awards, which totaled $2.0 million, $1.7 million and $1.0 million in fiscal 2020, 2019 and 2018, respectively. Restricted Stock activity was as follows: (In thousands, except per share data) Number of Shares Weighted Average Grant Price Unvested restricted stock awards at September 30, 2017 68 $ 23.98 Granted 56 34.38 Vested (29 ) 23.78 Forfeited (10 ) 29.10 Unvested restricted stock awards at September 30, 2018 85 30.30 Granted 45 56.05 Vested (39 ) 28.61 Forfeited (1 ) 47.86 Unvested restricted stock awards at September 30, 2019 90 43.69 Granted 67 41.40 Vested (43 ) 38.74 Forfeited (14 ) 44.76 Unvested restricted stock awards at September 30, 2020 100 $ 44.16 Restricted Stock Units and Deferred Stock Units The Company has entered into restricted stock unit agreements with certain key employees in foreign jurisdictions and members of the Board, covering the issuance of common stock (“RSUs”). With respect to employees, RSUs generally vest at a 33% rate on each of the first three anniversaries following the grant date, and RSUs are settled in shares and issued to the employees if they are employed by the Company at the end of the vesting period. With respect to members of the Board, RSUs vest on a monthly pro-rata basis within the one-year period following the date of grant, and RSUs are settled in shares and generally issued upon termination of service as a Board member. RSUs are valued based on the market value of the shares as of the date of grant with the value allocated to expense evenly over the vesting period. The Company awarded approximately 18,000, 12,000 and 22,000 RSUs in fiscal 2020, 2019 and 2018 respectively. As of September 30, 2020 and 2019, outstanding RSUs (including unvested units and vested units not yet settled) totaled approximately 65,000 and 62,000 units, respectively, with a weighted average grant date fair value of $2.5 million and $2.8 million, respectively. The stock-based compensation table above includes RSU expenses recognized related to these awards, which totaled $0.6 million, $0.6 million and $0.5 million in fiscal 2020, 2019 and 2018, respectively. Directors may elect to receive their annual fees for services to the Board in deferred stock units (“DSUs”). DSUs are fully vested and expensed upon grant at the market value of the shares on the grant date. DSUs are settled in shares and issued to the Director upon termination of service as a Board member. As of September 30, 2020 and 2019, outstanding, fully vested DSUs totaled approximately 33,000 and 30,000 units, respectively, with a weighted average grant date fair value of $1.3 million and $1.4 million, respectively. The stock-based compensation table above includes DSU expenses recognized related to these awards, which totaled $0.1 million per year in fiscal 2020, 2019 and 2018. Performance Share Awards In fiscal 2017 and prior years, the Company entered into performance share agreements with certain key employees covering the issuance of common stock (“Performance Shares”). The Organization and Compensation Committee of the Board of Directors (the “Committee”) established cumulative revenue and cumulative earnings before interest, income taxes, depreciation and amortization (“EBITDA”) for the applicable three-year 1999 Employee Stock Purchase Plan Under the amended 1999 Employee Stock Purchase Plan (“ESPP”), the Company is authorized to issue up to 600,000 shares of common stock. All full-time and part-time U.S. employees can elect to have up to 10% of their annual compensation withheld, with annual limit of $25,000, to purchase the Company’s common stock at purchase prices defined within the provisions of the ESPP. ESPP share awards are valued based on the value of the discount feature plus the fair value of the optional features as of the date of grant using the Black-Scholes valuation model. The value of these share awards is allocated to expense evenly over each six-month purchase period. Employee contributions to the ESPP included in accrued liabilities on the consolidated balance sheets totaled $0.1 million or less as of both September 30, 2020 and 2019. The stock-based compensation table above includes expenses recognized related to the ESPP, which totaled $0.2 million for fiscal 2020 and $0.1 million or less for both fiscal 2019 and 2018. |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes Income taxes in the accompanying consolidated statements of operations were as follows: Fiscal Year (In thousands) 2020 2019 2018 Current (benefit) provision: U.S. Federal $ (1,570 ) $ 1,355 $ (890 ) U.S. State 42 192 51 International 90 41 41 Total current (benefit) provision (1,438 ) 1,588 (798 ) Deferred (benefit) provision: U.S. Federal (1,336 ) (1,505 ) (2,006 ) U.S. State 197 (117 ) (271 ) International — — — Total deferred benefit (1) (1,139 ) (1,622 ) (2,277 ) Total income tax benefit $ (2,577 ) $ (34 ) $ (3,075 ) (1) Both the current and deferred benefit include the impact of the adoption of ASC Topic 606 in fiscal 2019, which reduced deferred income taxes and income taxes receivable by $1.2 million and $0.4 million, respectively, as of adoption (Note 2). The following is a reconciliation of the difference between amounts calculated at the statutory U.S. federal income tax rate of 21%, 21% and 24.5% for fiscal 2020, 2019 and 2018, respectively, and the Company’s effective tax rate: Fiscal Year (In thousands) 2020 2019 2018 Amount at statutory U.S. federal income tax rate $ (305 ) $ 1,587 $ (1,845 ) Change because of the following items: State income taxes, net of federal benefit (551 ) (452 ) (724 ) U.S. Federal and foreign research and development credits (1,571 ) (2,464 ) (1,710 ) Foreign and state rate differential 212 156 371 Valuation allowance change 825 671 960 Stock-based compensation (1) (81 ) (163 ) (2,063 ) Contingent consideration (gain) expense and related foreign currency revaluation — (61 ) 142 U.S. Federal and state rate change 17 44 1,582 Tax reserve change 609 770 158 Foreign-derived income deduction (88 ) (150 ) — Impact of CARES Act (1,700 ) — — Other 56 28 54 Income tax benefit $ (2,577 ) $ (34 ) $ (3,075 ) (1) Includes non-deductible stock-based compensation. In March 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted and included significant business tax provisions. In particular, the CARES Act modified the rules associated with net operating losses (“NOLs”) and made technical corrections to tax depreciation methods for qualified improvement property. Under the temporary provisions of CARES Act, NOL carryforwards and carrybacks may offset 100% of taxable income for taxable years beginning before 2021. In addition, NOLs arising in 2018, 2019 and 2020 taxable years may be carried back to each of the preceding five years to generate a refund. In fiscal 2020, the income tax benefit includes a discrete tax benefit of $1.7 million as a result of our ability under the CARES Act to carry back NOLs incurred to periods when the statutory tax rate was 35% versus our current tax rate of 21%. In December 2017, the Tax Cuts and Jobs Act (“TCJA”) tax legislation was signed into law, which reduced the U.S. federal statutory tax rate from 35% to 21%, among other changes. As of September 30, 2019, the Company had fully completed its accounting for the tax effects of the enactment of the TCJA. The fiscal 2018 income tax benefit includes discrete tax expense of $1.6 million from the revaluation of the Company’s net deferred tax assets based on the enacted tax rate of 21%, compared to the previous rate of 35%. U.S. tax law requires that taxpayers with a fiscal year beginning before and ending after the effective date of a rate change calculate a blended tax rate for the year based on the pro rata number of days in the year before and after such effective date. As a result, for fiscal 2018, our U.S. federal income tax rate was 24.5%. Excess tax benefits related to stock-based compensation expense are recorded within income tax benefit in the consolidated statements of operations and totaled $0.4 million, $0.5 million and $2.0 million for fiscal 2020, 2019 and 2018, respectively. The components of deferred income taxes consisted of the following and result from differences in the recognition of transactions for income tax and financial reporting purposes: September 30, (In thousands) 2020 2019 Depreciable assets $ (1,964 ) $ (905 ) Deferred revenue 2,029 1,554 Accruals and reserves 1,858 585 Stock-based compensation 2,232 2,213 Impaired strategic investments 1,767 1,666 NOL carryforwards 3,526 3,308 U.S. Federal and State R&D credits 3,216 2,394 Other 897 689 Valuation allowance (6,246 ) (5,328 ) Total deferred tax assets $ 7,315 $ 6,176 As of September 30, 2020 and 2019, deferred tax asset valuation allowances totaled $6.2 million and $5.3 million, respectively. The valuation allowances were primarily related to other-than-temporary impairment losses on strategic investments, state R&D credit carryforwards, and NOL carryforwards of Creagh Medical. As of September 30, 2020, the Company had federal and state R&D credit carryforwards of $3.2 million that will begin expiring in fiscal 2029 and U.S. federal and state NOL carryforwards of $0.1 million and $0.2 million tax-effected, respectively, that will begin expiring in fiscal 2034 and fiscal 2022, respectively. Ireland NOL carryforward tax assets totaled $3.2 million as of September 30, 2020, much of which was acquired as part of the Creagh Medical acquisition in fiscal 2016, and have an unlimited carryforward period. The U.S. federal and Minnesota NOLs acquired as part of the NorMedix acquisition are subject to the Internal Revenue Code Section 382 limitation rules. Unrecognized tax benefits are the differences between a tax position taken, or expected to be taken in a tax return, and the benefit recognized for accounting purposes pursuant to accounting guidance. The following is a reconciliation of the changes in unrecognized tax benefits, excluding interest and penalties: Fiscal Year (In thousands) 2020 2019 2018 Unrecognized tax benefits, beginning balance $ 2,323 $ 1,559 $ 1,481 Increases in tax positions for prior years 58 278 61 Decreases in tax positions for prior years (1 ) (2 ) — Increases in tax positions for current year 664 735 735 Settlements with taxing authorities — — (613 ) Lapse of the statute of limitations (173 ) (247 ) (105 ) Unrecognized tax benefits, ending balance $ 2,871 $ 2,323 $ 1,559 The total amount of unrecognized tax benefits excluding interest and penalties that, if recognized, would affect the effective tax rate was $2.7 million, $2.1 million and $1.4 million as of September 30, 2020, 2019 and 2018, respectively. Currently, the Company does not expect the liability for unrecognized tax benefits to change significantly in the next 12 months and has classified the above balances on the consolidated balance sheets in other long-term liabilities. Interest and penalties related to unrecognized tax benefits are recorded in income tax expense. As of September 30, 2020, 2019 and 2018, the gross amount accrued for interest and penalties on unrecognized tax benefits was $0.6 million, $0.5 million and $0.4 million, respectively. The Company files income tax returns, including returns for its subsidiaries, in the U.S. federal jurisdiction and in various state jurisdictions, as well as several non-U.S. jurisdictions. Uncertain tax positions are related to tax years that remain subject to examination. U.S. federal income tax returns for years prior to fiscal 2017 are no longer subject to examination by federal tax authorities. For tax returns for state and local jurisdictions, the Company is no longer subject to examination for tax years generally before fiscal 2009. For tax returns for non-U.S. jurisdictions, the Company is no longer subject to income tax examination for years prior to 2014. Additionally, the Company has been indemnified of liability for any taxes relating to Creagh Medical and NorMedix for periods prior to the respective acquisition dates, pursuant to the terms of the related share purchase agreements. As of September 30, 2020 and 2019, there were no undistributed earnings in foreign subsidiaries. |
Defined Contribution Plans
Defined Contribution Plans | 12 Months Ended |
Sep. 30, 2020 | |
Compensation And Retirement Disclosure [Abstract] | |
Defined Contribution Plans | 10. Defined Contribution Plans The Company has a 401(k) retirement and savings plan for the benefit of qualifying U.S. employees, and a defined contribution Personal Retirement Savings Account plan for the benefit of qualifying Ireland employees. For U.S. employees, the Company matches 50% of employee contributions on the first 6% of eligible compensation. For Ireland employees, the Company makes contributions of up to 8% of eligible compensation on employee contributions of up to 6% of eligible compensation. Expense recognized for Company contributions to defined contribution plans totaled $1.0 million, $0.9 million and $0.7 million in fiscal 2020, 2019 and 2018, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Sep. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies Litigation. From time to time, the Company may become involved in various legal actions involving its operations, products and technologies, including intellectual property and employment disputes. The outcomes of these legal actions are not within the Company’s complete control and may not be known for prolonged periods of time. In some actions, the claimants seek damages as well as other relief, including injunctions barring the sale of products that are the subject of the lawsuit, which if granted, could require significant expenditures or result in lost revenue. The Company records a liability in the consolidated financial statements for these actions when a loss is known or considered probable and the amount can be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate, the minimum amount of the range is accrued. If a loss is possible but not known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. In most cases, significant judgment is required to estimate the amount and timing of a loss to be recorded On January 17, 2018, the Company entered into a settlement agreement fully resolving the previously disclosed litigation involving Merit Medical Systems, Inc. (“Merit”) and NorMedix. In April 2018, a customer notified the Company that it believed it had overpaid hydrophilic coating royalties to the Company from January 2009 through December 2017. During fiscal 2018, the Company recorded $1.0 million in selling, general and administrative expenses related to this claim. During fiscal 2019, the Company settled this claim and made a payment to the customer totaling $0.4 million, resulting in a reduction of selling, general and administrative expenses of $0.6 million in fiscal 2019. InnoCore Technologies BV. In 2006, the Company entered into a license agreement whereby Surmodics obtained an exclusive license to a drug-delivery coating for licensed products within the vascular field which included peripheral, coronary and neurovascular biodurable stent products. The license requires an annual, minimum payment of approximately $0.2 million (at the Euro to U.S. dollar exchange rate of as of September 30, 2020) until the last patent expires, which is currently estimated to be May 2027. The total minimum future payments associated with this license are approximately $1.7 million. The license is currently utilized with one of Surmodics’ drug-delivery technology customers. Clinical Trials. The Company has engaged CRO consultants to assist with the administration of its ongoing clinical trials. The Company has executed separate contracts with two CROs for services rendered in connection with the TRANSCEND pivotal clinical trial for the DCB, including pass-through expenses paid by the CROs, of up to $30 million in the aggregate. As of September 30, 2020, an estimated $10 million remains to be paid on these contracts, which may vary depending on actual pass-through expenses incurred to execute the trial. The Company estimates that the total cost of the TRANSCEND clinical trial will be in the range of $35 million to $40 million from inception to completion. In the event the Company were to terminate any trial, it may incur certain financial penalties, which would become payable to the CRO for costs to wind down the terminated trial. Asset Acquisitions. In fiscal 2019, the Company acquired certain intellectual property assets to support ongoing development of the Company’s medical device pipeline and paid the sellers $0.8 million. In addition, the Company is obligated to pay up to $1.3 million of additional consideration upon achievement of certain strategic milestones within a contingency period ending in 2022, of which $0.2 million is guaranteed to be paid in fiscal 2021. In fiscal 2019, the Company recorded a charge totaling $0.9 million related to this acquisition in acquired in-process research and development expense on the consolidated statements of operations. In fiscal 2018, the Company acquired certain intellectual property assets of Embolitech, LLC (the “Embolitech Transaction”). As part of the Embolitech Transaction, the Company paid the sellers $5.0 million in fiscal 2018 and $1.0 million in fiscal 2020. The Company is obligated to pay additional installments totaling $3.5 million in several installments in fiscal 2021 through fiscal 2024, including $1.0 million as a result of the achievement of a contingent milestone in fiscal 2020, which is payable in fiscal 2021. These payments may be accelerated upon the occurrence of certain sales and regulatory milestones. An additional $1.0 million payment is contingent upon the achievement of a certain regulatory milestone within a contingency period ending in 2033. In fiscal 2018, the Company recorded a charge totaling $7.9 million related to this acquisition in acquired in-process research and development expense on the consolidated statement of operations. As of September 30, 2020, $1.1 million and $2.2 million related to these asset acquisitions was recorded in other accrued liabilities and other long-term liabilities, respectively, on the consolidated balance sheets. As of September 30, 2019, $1.0 million and $2.1 million related to these asset acquisitions was recorded in other accrued liabilities and other long-term liabilities, respectively, on the consolidated balance sheets. |
Reportable Segment Information
Reportable Segment Information | 12 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Reportable Segment Information | 12. Reportable Segment Information Operating segments are components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, who is the Company’s Chief Executive Officer, in deciding how to allocate resources and in assessing performance. We operate two reportable segments: • Medical Device: Surface modification coating technologies to improve access, deliverability, and predictable deployment of medical devices; drug-delivery coating technologies to provide site-specific drug-delivery from the surface of a medical device, with end markets that include coronary, peripheral, neuro-vascular and structural heart, among others; and the design, development and manufacture of interventional medical devices, primarily balloons and catheters, including drug-coated balloons, for peripheral arterial disease treatment and other applications; and • In Vitro Diagnostics: Design, development and manufacture of component products and technologies for diagnostic immunoassay as well as molecular test and biomedical research applications, with products that include protein stabilization reagents, substrates, surface coatings and antigens. Segment revenue, operating (loss) income, and depreciation and amortization were as follows: Fiscal Year (In thousands) 2020 2019 2018 Revenue: Medical Device $ 71,401 $ 78,353 $ 60,513 In Vitro Diagnostics 23,463 21,724 20,823 Total revenue $ 94,864 $ 100,077 $ 81,336 Operating (loss) income: Medical Device $ (3,246 ) $ 4,794 $ (8,478 ) In Vitro Diagnostics 11,771 10,620 8,619 Total segment operating (loss) income 8,525 15,414 141 Corporate (9,776 ) (8,945 ) (8,940 ) Total operating (loss) income $ (1,251 ) $ 6,469 $ (8,799 ) Depreciation and amortization: Medical Device $ 6,223 $ 5,811 $ 5,376 In Vitro Diagnostics 483 464 394 Corporate 557 1,037 661 Total depreciation and amortization $ 7,263 $ 7,312 $ 6,431 The Corporate category includes expenses that are not fully allocated to Medical Device and In Vitro Diagnostics segments. These Corporate costs are related to administrative corporate functions, such as executive management, corporate accounting, legal, human resources and Board of Directors. Corporate may also include expenses, such as litigation, which are not specific to a segment and thus not allocated to the operating segments. Asset information by segment is not presented because the Company does not provide its chief operating decision maker assets by segment, as the data is not readily available. Revenue from customers that equaled or exceeded 10% of total revenue was as follows: Fiscal Year 2020 2019 2018 Abbott 19 % 19 % 11 % Medtronic 14 % 14 % 16 % The revenue from the customers listed is derived from two primary sources: licensing and product sales (primarily in the Medical Device segment). Revenue by geographic region was as follows: Fiscal Year 2020 2019 2018 Domestic 78 % 81 % 79 % Foreign 22 % 19 % 21 % Long-lived assets by country, including property and equipment and intangible assets net of accumulated depreciation and amortization, respectively, were as follows: September 30, (In thousands) 2020 2019 U.S. $ 25,273 $ 24,450 Ireland 18,113 19,524 |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Sep. 30, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (Unaudited) | 13. Quarterly Financial Data (Unaudited) The following is a summary of the unaudited quarterly results: (In thousands, except per share data) First Quarter Second Quarter Third Quarter Fourth Quarter Fiscal Year 2020 Total revenue $ 22,616 $ 22,822 $ 26,883 $ 22,543 Operating (loss) income (266 ) (156 ) 1,164 (1,993 ) Net income (loss) 148 1,462 2,459 (2,946 ) Basic net income (loss) per share (1): 0.01 0.11 0.18 (0.22 ) Diluted net income (loss) per share (1): 0.01 0.11 0.18 (0.22 ) Fiscal Year 2019 Total revenue $ 22,241 $ 22,676 $ 24,344 $ 30,816 Operating income 712 865 1,017 3,875 Net income 1,310 1,262 1,466 3,554 Basic net income per share (1): 0.10 0.09 0.11 0.27 Diluted net income per share (1): 0.09 0.09 0.11 0.26 (1) The sum of the quarterly net income (loss) per share amounts may not equal the annual income per share total because of changes in the weighted average number of shares outstanding that occurred during the year. In the second quarter of fiscal 2020, the Company recorded an impairment charge of $0.5 million to reduce the value of its strategic investment in ViaCyte to zero. In the second quarter of fiscal 2020, the Company recorded a $1.8 million discrete tax benefit as a result of our ability under the CARES Act, which was enacted in March 2020, to carry back NOLs incurred to prior periods when the statutory rate was 35% versus the current tax rate of 21%. In the third quarter of fiscal 2020, the Company achieved a regulatory milestone related to its agreement with Abbott, which resulted in the receipt of a $ 10.8 million payment, of which $ 6.7 million was recognized as revenue for the quarter. In the third quarter of fiscal 2019, the Company recorded royalties revenue from the extension of a customer license agreement totaling $1.0 million. In the fourth quarter of fiscal 2019, the Company acquired certain technology assets resulting in a $0.9 million charge. In the fourth quarter of fiscal 2019, the Company achieved a clinical milestone related to its agreement with Abbott, which resulted in the receipt of a $10.0 million payment, of which $5.1 million was recognized as revenue for the quarter. |
Schedule of Valuation and Quali
Schedule of Valuation and Qualifying Accounts | 12 Months Ended |
Sep. 30, 2020 | |
Valuation And Qualifying Accounts [Abstract] | |
Schedule of Valuation and Qualifying Accounts | Surmodics, Inc. Schedule II – Valuation and Qualifying Accounts (In thousands) Balance at Beginning of Fiscal Year Additions: Charges to Income Deductions: Other Changes (Debit) Credit Balance at End of Fiscal Year Allowance for doubtful accounts: Fiscal year ended September 30, 2018 $ 230 $ 64 $ (147 ) (a) $ 147 Fiscal year ended September 30, 2019 147 188 (135 ) (a) 200 Fiscal year ended September 30, 2020 200 73 (143 ) (a) 130 (a) Primarily consists of uncollectible accounts written off, less recoveries. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Select Balance Sheet Information (Policies) | 12 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of financial instruments with maturities of three months or less at the Company’s acquisition date of the security and are stated at cost which approximates fair value and may include money market instruments, certificates of deposit, repurchase agreements and commercial paper instruments. |
Accounts Receivable, Net | Accounts Receivable, Net We grant credit to customers in the normal course of business and maintain an allowance for doubtful accounts which reflects our estimate of uncollectible accounts as of the balance sheet date. We consider various factors in establishing, monitoring, and adjusting the allowance for credit losses including the aging of the accounts and aging trends, the historical level of charge-offs, and specific exposures related to particular customers. |
Investments | Investments Investments consisted of commercial paper and corporate bond securities and are classified as available-for-sale as of September 30, 2020 and 2019. Available-for-sale debt securities are reported at fair value with unrealized gains and losses, net of tax, excluded from the consolidated statements of operations and reported in the consolidated statements of comprehensive income (loss) and as a separate component of stockholders’ equity in the consolidated balance sheets, except for other-than-temporary impairments, which are reported as a charge to current earnings as they occur. A loss would be recognized when there is an other-than-temporary impairment in the fair value of any individual security classified as available-for-sale, with the associated net unrealized loss reclassified out of accumulated other comprehensive income with a corresponding adjustment to other (expense) income. This adjustment would result in a new cost basis for the investment. No such adjustments occurred during fiscal 2020, 2019 or 2018. Interest earned on debt securities, including amortization of premiums and accretion of discounts, is included in other (expense) income. Realized gains and losses from the sales of available-for-sale debt securities, which are included in other (expense) income, are determined using the specific identification method. The amortized cost, unrealized holding gains and losses, and fair value of available-for-sale securities were as follows: September 30, 2020 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 30,313 $ 19 $ (19 ) $ 30,313 Total $ 30,313 $ 19 $ (19 ) $ 30,313 September 30, 2019 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 24,918 $ 13 $ — $ 24,931 Total $ 24,918 $ 13 $ — $ 24,931 There were no held-to-maturity debt securities as of September 30, 2020 or 2019. There were no realized gains or losses on sales of available-for-sale securities for fiscal 2020, 2019 or 2018. |
Inventories | Inventories Inventories are principally stated at the lower of cost or market using the specific identification method and include direct labor, materials and overhead, with cost of product sales determined on a first-in, first-out basis. Inventories consisted of the following components: |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less any impairment, and are depreciated using the straight-line method over the estimated useful lives of the assets. The Company recorded depreciation expense of $4.8 million, $4.7 million and $3.7 million in fiscal 2020, 2019 and 2018, respectively. The September 30, 2020 and 2019 balances in construction-in-progress include the cost of equipment and building improvements not yet placed in service in the Company’s Ballinasloe, Ireland and Eden Prairie, Minnesota facilities. As assets are placed in service, construction-in-progress is transferred to the specific property and equipment categories and depreciated over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the term of the lease or the estimated useful life of the asset. Expenditures for maintenance and repairs and minor renewals and betterments that do not extend or improve the life of the respective assets are expensed as incurred. Property and equipment consisted of the following components: Useful Life September 30, (Dollars in thousands) (Years) 2020 2019 Land N/A $ 4,419 $ 4,415 Laboratory fixtures and equipment 3 to 12 28,600 25,467 Buildings and improvements 3 to 20 25,638 24,513 Leasehold improvements 3 to 10 4,836 4,836 Office furniture and equipment 3 to 10 7,334 6,476 Construction-in-progress 2,238 2,030 Less: Accumulated depreciation (42,962 ) (37,989 ) Property and equipment, net $ 30,103 $ 29,748 |
Other Assets | Other Assets Other assets consisted of the following: September 30, (In thousands) 2020 2019 ViaCyte, Inc. $ — $ 479 Operating lease right-of-use assets 2,508 — Other noncurrent assets 1,761 1,645 Other assets, net $ 4,269 $ 2,124 The Company has invested a total of $5.3 million in ViaCyte, Inc. (“ViaCyte”), a privately-held California-based biotechnology firm that is developing a treatment for diabetes using coated islet cells, the cells that produce insulin in the human body. As of September 30, 2019, the balance of the investment of $0.5 million, which was net of previously recorded other-than-temporary impairments of $4.8 million, was accounted for under the cost method and represented less than a 1% ownership interest. The Company does not exert significant influence over ViaCyte’s operating or financial activities. The total carrying value of cost method investments is reviewed quarterly for changes in circumstances or the occurrence of events that suggest the Company’s investment may not be recoverable. The carrying value of cost method investments is not adjusted if there are no identified events or changes in circumstances that may have a material adverse effect on the fair value of the investment. In fiscal 2020, the Company recorded a $0.5 million other-than-temporary impairment loss based on a ViaCyte financing transaction during the period and market valuations to reduce the carrying value of the investment in ViaCyte to zero. The valuation methodology for determining the decline in value of the ViaCyte investment was based on Level 3 inputs that required management judgment (Note 5). Operating lease right-of-use assets as of September 30, 2020 are recorded in accordance with ASC Topic 842, which we adopted as of October 1, 2019. Other noncurrent assets include a receivable related to refundable Irish research and development tax credits and prepaid expenses related to our ongoing clinical trials. |
Intangible Assets | Intangible Assets Intangible assets consisted of the following: September 30, 2020 (Dollars in thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 18,213 $ (12,451 ) $ 5,762 Developed technology 11.5 9,685 (4,200 ) 5,485 Non-compete 5.0 230 (230 ) — Patents and other 14.7 3,321 (1,865 ) 1,456 Total definite-lived intangible assets 31,449 (18,746 ) 12,703 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 32,029 $ (18,746 ) $ 13,283 September 30, 2019 (Dollars in thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 17,374 $ (10,661 ) $ 6,713 Developed technology 11.5 9,490 (3,196 ) 6,294 Non-compete 5.0 230 (196 ) 34 Patents and other 16.5 2,321 (1,716 ) 605 Total definite-lived intangible assets 29,415 (15,769 ) 13,646 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 29,995 $ (15,769 ) $ 14,226 The Company recorded amortization expense of $2.5 million, $2.6 million and $2.7 million in fiscal 2020, 2019 and 2018, respectively. Based on the intangible assets in service as of September 30, 2020, estimated amortization expense for each of the next five fiscal years is as follows: (In thousands) 2021 $ 2,488 2022 2,448 2023 1,843 2024 1,750 2025 1,712 Future amortization amounts presented above are estimates. Actual future amortization expense may be different as a result of future acquisitions, impairments, changes in amortization periods, foreign currency exchange rates or other factors. The Company defines in-process research and development (“IPR&D”) as the value of technology acquired for which the related projects have substance and are incomplete. IPR&D acquired in a business combination is recognized at fair value and is capitalized as an indefinite-lived intangible asset until completion or abandonment of the IPR&D project. Upon completion of the development project (generally when regulatory approval to market the product is obtained), an impairment assessment is performed prior to amortizing the asset over its estimated useful life. In cases where the IPR&D projects are abandoned, the related IPR&D assets are written off. The Company assesses indefinite-lived assets for impairment annually in the fourth quarter and whenever an event occurs or circumstances change that would indicate that the carrying amount may be impaired. Similar to the goodwill impairment assessment, the indefinite-lived assets impairment assessment requires the Company to make several estimates about fair value, most of which are based on projected future cash flows. The Company performs its annual assessment of indefinite-lived intangible assets for impairment as of July 1 st of each fiscal year. In fiscal 2020, the annual assessment date for impairment was changed to July 1 st from the August 31 st date used in fiscal 2019 and prior years. After completing the fiscal 20 19 impairment analys is , the fair value of certain IPR&D and trade name assets were deemed to be less than their carrying value, due to decreases in estimated future revenue associated with the assets. Accordingly, in fiscal 2019 , impairment losses on indefinite-lived intangible assets totaling $ 0.3 million were recorded in research and development expense in the consolidated statements of operations . No impairment charges were recorded in fiscal 2020 and 2018 as there were no indicators of impairment associated with indefinite-lived intangible assets. The valuation methodology for determining the decline in value of the indefinite-lived intangible assets in fiscal 2019 was based on Level 3 inputs that require management judgment (Note 5) . |
Goodwill | Goodwill Goodwill represents the excess of the purchase price of an acquired business over the fair value assigned to the assets purchased and liabilities assumed. Goodwill is not amortized but is subject, at a minimum, to annual tests for impairment in accordance with accounting guidance for goodwill. The carrying amount of goodwill is evaluated annually, and between annual evaluations if events occur or circumstances change indicating that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. The Company’s reporting units are the In Vitro Diagnostics and Medical Device operating segments. Inherent in the determination of fair value of the reporting units are certain estimates and judgments, including the interpretation of current economic indicators and market valuations, as well as the Company’s strategic plans with regard to its operations. The Company performs its annual assessment of goodwill for impairment as of July 1 st st st The impairment assessment is reliant on forecasted cash flows, as well as the selected discount rate when a quantitative assessment is necessary, which are inherently subjective and require significant management estimates. Differences in the reporting units’ actual future operating results compared to these forecasted estimates could materially affect the estimation of the fair value of the reporting units. Goodwill was not impaired in either reporting unit based on the outcome of the fiscal 2020 annual impairment test which utilized a quantitative assessment. Goodwill in the Medical Device reporting unit represents the gross value from the acquisitions of Creagh Medical, Ltd. (“Creagh Medical”) and NorMedix, Inc. (“NorMedix”), which were completed in fiscal 2016. Goodwill in the In Vitro Diagnostics reporting unit represents the gross value from the acquisition of BioFX Laboratories, Inc. in 2007. Changes in the carrying amount of goodwill by reportable segment were as follows: (In thousands) In Vitro Diagnostics Medical Device Total Balance as of September 30, 2018 $ 8,010 $ 19,022 $ 27,032 Foreign currency translation adjustment — (861 ) (861 ) Balance as of September 30, 2019 8,010 18,161 26,171 Foreign currency translation adjustment — 1,014 1,014 Balance as of September 30, 2020 $ 8,010 $ 19,175 $ 27,185 |
Valuation of Long-lived Assets | Valuation of Long-lived Assets The Company periodically evaluates whether events and circumstances have occurred that may affect the estimated useful life or the recoverability of the remaining balance of long-lived assets, such as property and equipment, right-of-use assets, and definite-lived intangible assets. If such events or circumstances were to indicate that the carrying amount of these assets may not be recoverable, the Company would estimate the future cash flows expected to result from the use of the assets and their eventual disposition. If the sum of the expected future cash flows (undiscounted and without interest charges) were less than the carrying amount of the assets, the Company would recognize an impairment charge to reduce such assets to their fair value. In fiscal 2020, 2019 and 2018, there were no impairment charges relating to the Company’s long-lived assets as there were no events or circumstances that occurred that affected the recoverability of such assets. |
Accrued Other Liabilities | Accrued Other Liabilities Accrued other liabilities consisted of the following: September 30, (In thousands) 2020 2019 Accrued professional fees $ 239 $ 434 Accrued clinical study expense 2,206 2,163 Accrued purchases 647 679 Acquisition of in-process research and development and intangible assets 1,148 989 Due to customers 321 19 Construction-in-progress 272 — Operating lease liability, current portion 436 — Deferred rent, current portion — 130 Other 278 376 Total accrued other liabilities $ 5,547 $ 4,790 |
Revenue Recognition | Revenue Recognition Adoption of ASC Topic 606 in Fiscal 2019 Effective in fiscal 2019 (October 1, 2018), the Company adopted Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers The adoption of ASC Topic 606 in fiscal 2019 resulted in cumulative-effect adjustments to opening retained earnings, contract assets, deferred tax assets and income tax receivable as summarized below: (In thousands) September 30, 2018, As Reported Adjustments for Adoption of Topic 606 October 1, 2018 Opening Balance Assets Contract assets - royalties and license fees $ — $ 6,904 $ 6,904 Deferred income taxes 6,304 (1,215 ) 5,089 Income tax receivable 1,152 (390 ) 762 Liabilities and Stockholders' Equity Deferred revenue, current portion 9,646 (18 ) 9,628 Deferred revenue, less current portion 11,247 (181 ) 11,066 Retained earnings 97,615 5,498 103,113 The impact of adoption of ASC Topic 606 to the Company’s consolidated statements of operations for fiscal 2019 was an increase in royalties and license fee revenue of $1.3 million, as well as reduced income tax benefit of $0.3 million. Revenue is recognized when control of the promised goods or services is transferred to our customers in an amount that reflects the consideration we expect to be entitled to receive in exchange for those goods or services. The Company primarily sells or licenses its products, technologies and services to other medical device and diagnostics companies. Taxes collected from customers and remitted to governmental authorities that are imposed on, and concurrent with, a specific revenue producing transaction are excluded from revenue. For contracts that have an original duration of one year or less, the Company uses the practical expedient applicable to such contracts and does not adjust the transaction price for the time value of money. Performance Obligations We derive our revenue from three primary sources: • Product revenues from the sale of chemical components within our IVD segment, including stabilization products, substrates, surface coatings, and antigens to the diagnostic and biomedical research markets; the sale of reagent chemicals to licensees within our Medical Device segment; and the sale of medical devices and related products (such as balloons and catheters) to original equipment manufacturer (“OEM”) suppliers and distributors within our Medical Device segment; • Royalties and license fees from licensing our proprietary surface modification coating and medical device technologies to our medical device manufacturers within our Medical Device segment; and • Research and development fees generated from contract coating services within our Medical Device segment and new product development and testing within our Medical Device and IVD segments. The Company recognizes revenue when control is transferred to the customer. The transfer of control varies by revenue classification and is described below. Product Sales . Revenue from product sales is recognized at the point in time control of the products is transferred, generally upon shipment based upon the standard contract terms. Shipping and handling activities are considered to be fulfillment activities rather than promised services and are not, therefore, considered to be separate performance obligations. The Company’s sales terms provide no right of return outside of a standard warranty policy, and returns are generally not significant. Payment terms for product sales are generally set at 30-45 days after shipment Royalties . Royalties revenue consists of sales-based and recurring minimum royalties earned under licenses of our surface modification coating technologies. Performance obligations under these licenses, which consist of the right to use the Company’s proprietary technology, are satisfied at a point in time corresponding with delivery of the underlying technology rights to the customer, which is generally upon transfer of the licensed technology to the customer. Sales-based royalties revenue represents variable consideration under the license agreements and is recognized in the period a customer sells products incorporating the Company’s licensed technologies. The Company estimates sales-based royalties revenue earned but unpaid at each reporting period using the expected value method based on historical sales information, adjusted for known changes such as product launches and patent expirations. The Company also considers macroeconomic factors affecting the medical device market. The Company's license arrangements also often provide for recurring fees (minimum royalties), which the Company recognizes at the later of the satisfaction of the underlying performance obligation or upon renewal of the contract, which generally occurs on a quarterly basis. Sales-based and minimum royalties are generally due within 45 days after the end of each quarter. License Fees . For distinct license performance obligations, upfront license fees are recognized when the Company satisfies the underlying performance obligation. This generally occurs upon transfer of the right to use the Company’s licensed technology to the customer, with the exception of the license of the Company’s SurVeil™ drug-coated balloon (the “ DCB”) disclosed below. Certain license arrangements include contingent milestone payments, which are due following achievement by our customers of specified sales or regulatory milestones. Contingent milestone payment terms vary by contract. The Company has generally fulfilled its performance obligation prior to achievement of these milestones. However, because of the uncertainty of the milestone achievement, and/or the dependence on sales of our customers, variable consideration for contingent milestones is fully constrained and excluded from the contract price until the milestone is achieved by our customer, to the extent collectability is reasonably certain. The Company has a collaborative arrangement contract with Abbott Vascular, Inc. (“Abbott”) disclosed in Note 4 (the “Abbott Agreement”). Under the Abbott Agreement, the Company has received payments totaling $45.8 million, which consisted of the following: $25 million upfront fee in fiscal 2018, $10 million milestone payment in fiscal 2019 upon completion of enrollment in the TRANSCEND clinical trial, and $10.8 million milestone payment in fiscal 2020 upon receipt of Conformité Européenne Mark (“CE Mark”) approval prerequisite for commercialization of the SurVeil The Company consisting of: (i) $15 million upon successful completion of the clinical study report of the TRANSCEND pivotal trial demonstrating safety and clinical non-inferiority with the control device and (ii) $30 million upon premarket approval of our SurVeil DCB by the U.S. Food and Drug Administration (“FDA”). The performance obligation identified in this arrangement includes delivery of our licensed technology and completion of research and development activities, primarily clinical trial activities (together, “R&D and Clinical Activities”). These promises are not distinct performance obligations because the product necessary for completion of the R&D and Clinical Activities is currently only able to be manufactured by the Company due to the exclusive proprietary know-how and certain regulatory requirements associated with the manufacture of the product. SurVeil using the cost-to-cost method which measures progress based on costs incurred to date relative to the expected total cost of the services, as the Company believes this represents a faithful depiction of the satisfaction of its performance obligation. Revenue from the upfront fee and contingent clinical and regulatory milestone payments, once the underlying contingencies are achieved, is recognized within royalties and license fees in the consolidated statements of operations as the clinical and regulatory activities are performed on a proportional performance basis. Performance is measured based on actual costs incurred relative to the expected total cost of the underlying activities, most notably the completion of the TRANSCEND clinical trial. A significant component of the cost of this trial is the cost of the Company’s outsourced clinical trial clinical research organization (“CRO”) consultants, which is estimated based on executed statements of work, project budgets, and patient enrollment timing, among other factors. A significant change to the Company’s estimate of the costs to complete the TRANSCEND clinical trial could have a material effect on the Company’s results of operations. Significant judgment is used to estimate total revenue and cost at completion for this contract. To account for the Abbott Agreement, the Company applied the guidance in ASC Topic 808 (Collaborative Arrangements) as the parties are active participants and are exposed to significant risks and rewards dependent on commercial success of the collaborative activity. See Note 4 “Collaborative Arrangements” for further disclosures related to the Abbott Agreement. Research and Development . The Company performs research and development (“R&D”) activities as a service to customers, which are typically charged to customers on a time-and-materials basis. Generally, revenue for R&D services is recorded over time as the services are provided to the customer in the amount to which the Company has the right to invoice. These services are generally charged to the customer as they are provided. Payment terms for R&D services are generally set at 30-45 days. Contract Assets, Deferred Revenue and Remaining Performance Obligations Contract assets are generally short in duration given the nature of products produced and services provided by the Company. Contract assets consist of sales-based and minimum royalties revenue earned for which unconditional right to payment does not exist as of the balance sheet date. These assets are comprised of estimated sales-based royalties earned, but not yet reported by the Company’s customers, minimum royalties on non-cancellable contracts, and contingent milestones earned, but not yet billable based on the terms of the contract. The decrease in contract assets from September 30, 2019 to September 30, 2020 resulted primarily from changes in sales-based and minimum royalties earned, but not collected at each balance sheet date, notably due to the expiration of our fourth-generation hydrophilic coating patents in fiscal 2020 and the impact of COVID-19. The Company records a contract liability, or deferred revenue, when there is an obligation to provide a product or service to the customer, and payment is received or due in advance of performance, or when payment is received for a period outside the contract term. The Company’s deferred revenue as of September 30, 2020 and 2019 is primarily related to the upfront and milestone payments received pursuant to the Abbott Agreement (Note 4). Remaining performance obligations include deferred revenue and amounts the Company expects to receive for goods and services that have not yet been delivered or provided under existing, noncancellable contracts. For contracts that have an original duration of one year or less, the Company has elected the practical expedient applicable to such contracts and does not disclose the transaction price for remaining performance obligations at the end of each reporting period or the expecting timing of recognition of related revenue. As of September 30, 2020, the estimated revenue expected to be recognized in future periods totaled approximately $15.9 million related to performance obligations that are unsatisfied for executed contracts with an original duration of one year or more. This revenue is entirely related to the R &D and Clinical Activities performance obligation in the Abbott Agreement from the upfront payment and milestone payments and excludes revenue from potential contingent milestone payments that may be received in the future performance obligation |
Concentrations | Concentrations The Company has licenses and supply agreements with a diverse base of customers, and certain customers have multiple products using the Company’s technology. Abbott and its affiliates and Medtronic plc (“Medtronic”) are our largest customers, comprising 19% and 14%, respectively, of our consolidated revenue for both fiscal 2020 and 2019. These same customers each comprised 11% and 16%, respectively, of our consolidated revenue for fiscal 2018. Abbott has several separately licensed products, including the SurVeil DCB license, which generate royalties and license fee revenue for Surmodics. Revenue from the SurVeil DCB license represented 13%, 13% and 5% of total revenue for fiscal 2020, 2019 and 2018, respectively. Medtronic has several separately licensed products that generate royalties revenue for Surmodics, none of which represented more than 5% of our consolidated revenue for fiscal 2020 The Company’s licensing agreements with many of its customers, including most of its significant customers, cover many licensed products that each separately generates royalties revenue. This structure reduces the potential risk to the Company’s operations that may result from reduced sales (or the termination of a license) of a single product for any specific customer. The Company believes that the credit risk related to marketable securities is limited due to the adherence to an investment policy and that credit risk related to accounts receivable is limited due to a large customer base. |
Stock-based Compensation | Stock-based Compensation We measure the cost of employee services received in exchange for the award of equity instruments based on the fair value of the award at the date of grant. Share-based payments are expensed based on their grant-date fair values on a straight-line basis over the requisite service period of the total award, less estimated forfeitures based on historical experience. Shares awarded under the Company’s stock-based compensation plans, with the exception of restricted stock awards, are not considered issued or outstanding common stock of the Company until they vest and the shares are released. New awards and forfeitures of unvested restricted stock result in an increase (decrease), respectively, in common stock issued and outstanding. |
Income Taxes | Income Taxes We record a tax benefit (provision) for the anticipated tax consequences of the reported results of operations. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is provided when it is more likely than not that some portion, or all, of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in this assessment. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in earnings in the period that includes the enactment date of such change. |
Research and Development | Research and Development R&D expenses include costs associated with the design, development, testing, enhancement and regulatory approval of the Company’s products. R&D expenses include employee compensation (including stock-based compensation), internal and external costs associated with our regulatory compliance and quality assurance functions, the costs of product used in development and clinical trials, consulting expenses, and facilities overhead. The Company also incurs significant R&D expenses to operate clinical trials. R&D costs are expensed as incurred. Certain R&D costs are related to customer contracts, and the related revenue is recognized as described in “Revenue Recognition” above. Costs associated with customer-related R&D include specific project direct labor and materials expenses, as well as an allocation of overhead costs based on direct labor costs. Clinical Trial Costs. The Company sponsors clinical trials intended to obtain the necessary clinical data required to obtain approval from various regulatory agencies to market medical devices developed by the Company. Costs associated with clinical trials include trial design and management expenses, clinical site reimbursements and third-party fees, among other costs. The Company’s clinical trials are administered by third-party CROs. These CROs generally bill monthly for certain services performed, as well as upon achievement of certain milestones. The Company monitors patient enrollment, the progress of clinical studies, and related activities through internal reviews of data reported to the Company by the CROs and correspondence with the CROs. We periodically evaluates our estimates to determine if adjustments are necessary or appropriate based on information received. These estimates often require significant judgement on the part of the Company’s management. Government Funding . The Company is eligible to receive reimbursement for certain qualifying R&D expenditures under a grant from the Industrial Development Agency of Ireland (“IDA”). Reimbursements are recognized as a reduction of R&D expense when there is reasonable assurance that the funding will be received and conditions associated with the funding are met. The Company recorded reimbursements from IDA grants of $0.8 million, $0.7 million and $0.8 million in fiscal 2020, 2019 and 2018, respectively, as a reduction of R&D expense. |
Net Income (Loss) Per Share Data | Net Income (Loss) Per Share Data Basic net income (loss) per common share is calculated by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted income per common share is computed by dividing net income by the weighted average number of common and common equivalent shares outstanding during the period. The Company’s potentially dilutive common shares are those that result from dilutive common stock options and non-vested stock relating to restricted stock awards and restricted stock units. However, these items have been excluded from the calculation of diluted net loss per share for fiscal 2018, as their effect was antidilutive as a result of the net loss incurred for that period. Therefore, diluted weighted average number of shares outstanding and diluted net loss per share were the same as basic weighted average number of shares outstanding and net loss per share for fiscal 2018. The following table sets forth the denominator for the computation of basic and diluted net income (loss) per share: Fiscal Year (In thousands) 2020 2019 2018 Net income (loss) available to common shareholders $ 1,123 $ 7,592 $ (4,457 ) Basic weighted average shares outstanding 13,552 13,389 13,157 Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units 260 390 — Diluted weighted average shares outstanding 13,812 13,779 13,157 The calculation of weighted average diluted shares outstanding excludes outstanding common stock options associated with the right to purchase less than 0.1 million shares for fiscal 2020 and 0.2 million and 1.0 million shares for fiscal 2019 and 2018, respectively, as their inclusion would have had an antidilutive effect on diluted income per share for those periods. |
Leases | Leases Effective in fiscal 2020 (October 1, 2019), the Company adopted ASU No. 2016-02, Leases The Company’s leases include one or more options to renew and extend the lease term at the Company’s discretion. These renewal options are not included in right-of-use assets and lease liabilities as they are not reasonably certain of exercise. The Company regularly evaluates renewal options, and when they are reasonably certain to be exercised, the renewal period is included in the lease term. Operating lease right-of-use assets and lease liabilities were as follows: (In thousands) September 30, 2020 Right-of-use assets: Other assets $ 2,508 Operating lease liabilities: Other accrued liabilities $ 436 Other long-term liabilities 3,340 Total operating lease liabilities $ 3,776 As of September 30, 2020, operating lease maturities for each of the next five fiscal years were as follows: (In thousands) 2021 $ 586 2022 612 2023 625 2024 638 2025 651 Thereafter 1,521 Total expected operating lease payments 4,633 Less: Imputed interest (857 ) Total operating lease liabilities $ 3,776 Operating lease cost was $0.6 million for fiscal 2020. Rent expense for both fiscal 2019 and 2018 was $0.5 million. Cash paid for operating lease liabilities approximated operating lease cost for fiscal 2020. As of September 30, 2020, the weighted average remaining lease term for operating leases was 7.3 years, and the weighted average discount rate used to determine operating lease liabilities was 4.0%. |
Currency Translation | Currency Translation The Company’s reporting currency is the U.S. dollar. Assets and liabilities of non-U.S. dollar functional currency subsidiaries are translated into U.S. dollars at the period-end exchange rates, and revenue and expenses are translated at the average quarterly exchange rates during the period. The net effect of these translation adjustments on the consolidated financial statements is recorded as a foreign currency translation adjustment, a component of accumulated other comprehensive income |
New Accounting Pronouncements | New Accounting Pronouncements Accounting Standards Implemented In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases Effective in fiscal 2020 (October 1, 2019), the Company adopted the new lease accounting standard using the optional transition method which allowed us to continue to apply the guidance under the lease standard in effect at the time in the comparative periods presented. In addition, the Company elected the package of practical expedients, including opting not to reassess whether any existing contracts contain a lease, historical lease classification as operating or finance leases, or initial direct costs. The Company has also elected the practical expedient to not separate the lease and non-lease components for all classes of underlying assets. The Company elected the short-term lease recognition exemption for all leases that qualified and has accordingly excluded short-term leases from the recognition of right-of-use assets and lease liabilities. As a result of adoption of ASC Topic 842, we recorded operating lease right-of-use assets and corresponding operating lease liabilities of approximately $1.7 million and $2.9 million, respectively, as of October 1, 2019 with no impact on retained earnings. In addition, deferred rent liabilities related to escalating rent payments and tenant incentives totaling approximately $1.2 million were eliminated upon adoption, as these items were netted against right-of-use assets. The consolidated balance sheets for reporting periods beginning on or after October 1, 2019 are presented under the new guidance, while prior period amounts are not adjusted and continue to be reported in accordance with previous guidance. Accounting Standards to be Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses, Measurement of Credit Losses on Financial Statements In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Select Balance Sheet Information (Tables) | 12 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Amortized Cost, Unrealized Holding Gains (Losses) and Fair Value of Available for Sale Securities | The amortized cost, unrealized holding gains and losses, and fair value of available-for-sale securities were as follows: September 30, 2020 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 30,313 $ 19 $ (19 ) $ 30,313 Total $ 30,313 $ 19 $ (19 ) $ 30,313 September 30, 2019 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 24,918 $ 13 $ — $ 24,931 Total $ 24,918 $ 13 $ — $ 24,931 |
Components of Inventories | Inventories consisted of the following components: |
Schedule of Property, Plant and Equipment | Property and equipment consisted of the following components: Useful Life September 30, (Dollars in thousands) (Years) 2020 2019 Land N/A $ 4,419 $ 4,415 Laboratory fixtures and equipment 3 to 12 28,600 25,467 Buildings and improvements 3 to 20 25,638 24,513 Leasehold improvements 3 to 10 4,836 4,836 Office furniture and equipment 3 to 10 7,334 6,476 Construction-in-progress 2,238 2,030 Less: Accumulated depreciation (42,962 ) (37,989 ) Property and equipment, net $ 30,103 $ 29,748 |
Summary of Other Assets | Other assets consisted of the following: September 30, (In thousands) 2020 2019 ViaCyte, Inc. $ — $ 479 Operating lease right-of-use assets 2,508 — Other noncurrent assets 1,761 1,645 Other assets, net $ 4,269 $ 2,124 |
Schedule of Intangible Assets | Intangible assets consisted of the following: September 30, 2020 (Dollars in thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 18,213 $ (12,451 ) $ 5,762 Developed technology 11.5 9,685 (4,200 ) 5,485 Non-compete 5.0 230 (230 ) — Patents and other 14.7 3,321 (1,865 ) 1,456 Total definite-lived intangible assets 31,449 (18,746 ) 12,703 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 32,029 $ (18,746 ) $ 13,283 September 30, 2019 (Dollars in thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 17,374 $ (10,661 ) $ 6,713 Developed technology 11.5 9,490 (3,196 ) 6,294 Non-compete 5.0 230 (196 ) 34 Patents and other 16.5 2,321 (1,716 ) 605 Total definite-lived intangible assets 29,415 (15,769 ) 13,646 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 29,995 $ (15,769 ) $ 14,226 |
Estimated Amortization Expense | Based on the intangible assets in service as of September 30, 2020, estimated amortization expense for each of the next five fiscal years is as follows: (In thousands) 2021 $ 2,488 2022 2,448 2023 1,843 2024 1,750 2025 1,712 |
Schedule of Carrying Amount of Goodwill By Reportable Segment | Changes in the carrying amount of goodwill by reportable segment were as follows: (In thousands) In Vitro Diagnostics Medical Device Total Balance as of September 30, 2018 $ 8,010 $ 19,022 $ 27,032 Foreign currency translation adjustment — (861 ) (861 ) Balance as of September 30, 2019 8,010 18,161 26,171 Foreign currency translation adjustment — 1,014 1,014 Balance as of September 30, 2020 $ 8,010 $ 19,175 $ 27,185 |
Schedule of Accrued Other Liabilities | Accrued other liabilities consisted of the following: September 30, (In thousands) 2020 2019 Accrued professional fees $ 239 $ 434 Accrued clinical study expense 2,206 2,163 Accrued purchases 647 679 Acquisition of in-process research and development and intangible assets 1,148 989 Due to customers 321 19 Construction-in-progress 272 — Operating lease liability, current portion 436 — Deferred rent, current portion — 130 Other 278 376 Total accrued other liabilities $ 5,547 $ 4,790 |
Denominator for Computation of Basic and Diluted Net Income (Loss) Per Share | The following table sets forth the denominator for the computation of basic and diluted net income (loss) per share: Fiscal Year (In thousands) 2020 2019 2018 Net income (loss) available to common shareholders $ 1,123 $ 7,592 $ (4,457 ) Basic weighted average shares outstanding 13,552 13,389 13,157 Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units 260 390 — Diluted weighted average shares outstanding 13,812 13,779 13,157 |
Balance Sheet Classification and Amounts of Right-of-Use Assets and Lease Liabilities | Operating lease right-of-use assets and lease liabilities were as follows: (In thousands) September 30, 2020 Right-of-use assets: Other assets $ 2,508 Operating lease liabilities: Other accrued liabilities $ 436 Other long-term liabilities 3,340 Total operating lease liabilities $ 3,776 |
Schedule of Operating Lease Maturities | As of September 30, 2020, operating lease maturities for each of the next five fiscal years were as follows: (In thousands) 2021 $ 586 2022 612 2023 625 2024 638 2025 651 Thereafter 1,521 Total expected operating lease payments 4,633 Less: Imputed interest (857 ) Total operating lease liabilities $ 3,776 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Sep. 30, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Summary of Revenues Disaggregated by Product Classification and Reportable Segment | The following table presents the Company’s revenues disaggregated by product classification and by reportable segment: Fiscal Year (In thousands) 2020 2019 2018 Medical Device Product sales $ 21,608 $ 18,617 $ 17,200 Royalties 28,614 34,781 30,606 License fees 12,020 13,678 4,818 Research, development and other 9,159 11,277 7,889 Total Revenue — Medical Device 71,401 78,353 60,513 In Vitro Diagnostics Product sales 22,709 21,390 20,789 Other 754 334 34 Total Revenue — In Vitro Diagnostics 23,463 21,724 20,823 Total Revenue $ 94,864 $ 100,077 $ 81,336 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on Recurring Basis | Assets and liabilities measured at fair value on a recurring basis by level of the fair value hierarchy were as follows: September 30, 2020 (In thousands) Quoted Prices in Active Markets for Identical Instruments (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Fair Value Assets Cash equivalents $ — $ 18,634 $ — $ 18,634 Available-for-sale securities — 30,313 — $ 30,313 Total assets $ — $ 48,947 $ — $ 48,947 September 30, 2019 (In thousands) Quoted Prices in Active Markets for Identical Instruments (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Fair Value Assets Cash equivalents $ — $ 24,375 $ — $ 24,375 Available-for-sale securities — 24,931 — $ 24,931 Total assets $ — $ 49,306 $ — $ 49,306 Liabilities Contingent consideration $ — $ — $ 3,200 $ 3,200 Total liabilities $ — $ — $ 3,200 $ 3,200 |
Schedule of Contingent Consideration Liabilities Measured at Fair Value | Changes in the contingent consideration liabilities measured at fair value using Level 3 inputs were as follows: (In thousands) Contingent consideration liability at September 30, 2018 $ 14,466 Additions — Fair value adjustments (415 ) Settlements (10,979 ) Interest accretion 254 Foreign currency translation (126 ) Contingent consideration liability at September 30, 2019 3,200 Additions — Fair value adjustments — Settlements (3,200 ) Interest accretion — Foreign currency translation — Contingent consideration liability at September 30, 2020 $ — |
Stock-based Compensation Plans
Stock-based Compensation Plans (Tables) | 12 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation Expenses | Stock-based compensation expense was reported as follows in the consolidated statements of operations: Fiscal Year (In thousands) 2020 2019 2018 Product costs $ 119 $ 135 $ 69 Research and development 896 876 801 Selling, general and administrative 4,438 4,066 3,937 Total stock-based compensation expense $ 5,453 $ 5,077 $ 4,807 |
Stock Option Fair Value Assumptions and Weighted Average Fair Value of Stock Options Granted | Stock option fair value assumptions and the weighted average fair value of stock options granted were as follows: Fiscal Year 2020 2019 2018 Stock option fair value assumptions: Risk-free interest rates 1.41 % 2.75 % 2.18 % Expected life (years) 4.6 4.5 4.8 Expected volatility 39 % 34 % 33 % Dividend yield — % — % — % Weighted average grant date fair value of stock options granted $ 14.13 $ 17.89 $ 10.91 |
Schedule of Stock Option Activity | Stock option activity was as follows: (In thousands, except per share data) Number of Shares Weighted Average Exercise Price Options outstanding at September 30, 2017 1,002 $ 21.54 Granted 270 34.08 Exercised (450 ) 19.46 Forfeited and expired (111 ) 30.18 Options outstanding at September 30, 2018 711 26.28 Granted 179 55.09 Exercised (13 ) 22.03 Forfeited and expired (6 ) 42.28 Options outstanding at September 30, 2019 871 32.18 Granted 299 41.06 Exercised (125 ) 22.89 Forfeited and expired (105 ) 41.69 Options outstanding at September 30, 2020 940 35.18 Options vested and exercisable at September 30, 2020 472 $ 28.65 |
Schedule of Restricted Stock Activity | Restricted Stock activity was as follows: (In thousands, except per share data) Number of Shares Weighted Average Grant Price Unvested restricted stock awards at September 30, 2017 68 $ 23.98 Granted 56 34.38 Vested (29 ) 23.78 Forfeited (10 ) 29.10 Unvested restricted stock awards at September 30, 2018 85 30.30 Granted 45 56.05 Vested (39 ) 28.61 Forfeited (1 ) 47.86 Unvested restricted stock awards at September 30, 2019 90 43.69 Granted 67 41.40 Vested (43 ) 38.74 Forfeited (14 ) 44.76 Unvested restricted stock awards at September 30, 2020 100 $ 44.16 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Taxes | Income taxes in the accompanying consolidated statements of operations were as follows: Fiscal Year (In thousands) 2020 2019 2018 Current (benefit) provision: U.S. Federal $ (1,570 ) $ 1,355 $ (890 ) U.S. State 42 192 51 International 90 41 41 Total current (benefit) provision (1,438 ) 1,588 (798 ) Deferred (benefit) provision: U.S. Federal (1,336 ) (1,505 ) (2,006 ) U.S. State 197 (117 ) (271 ) International — — — Total deferred benefit (1) (1,139 ) (1,622 ) (2,277 ) Total income tax benefit $ (2,577 ) $ (34 ) $ (3,075 ) (1) Both the current and deferred benefit include the impact of the adoption of ASC Topic 606 in fiscal 2019, which reduced deferred income taxes and income taxes receivable by $1.2 million and $0.4 million, respectively, as of adoption (Note 2). |
Schedule of Reconciliation Difference of Income Taxes | The following is a reconciliation of the difference between amounts calculated at the statutory U.S. federal income tax rate of 21%, 21% and 24.5% for fiscal 2020, 2019 and 2018, respectively, and the Company’s effective tax rate: Fiscal Year (In thousands) 2020 2019 2018 Amount at statutory U.S. federal income tax rate $ (305 ) $ 1,587 $ (1,845 ) Change because of the following items: State income taxes, net of federal benefit (551 ) (452 ) (724 ) U.S. Federal and foreign research and development credits (1,571 ) (2,464 ) (1,710 ) Foreign and state rate differential 212 156 371 Valuation allowance change 825 671 960 Stock-based compensation (1) (81 ) (163 ) (2,063 ) Contingent consideration (gain) expense and related foreign currency revaluation — (61 ) 142 U.S. Federal and state rate change 17 44 1,582 Tax reserve change 609 770 158 Foreign-derived income deduction (88 ) (150 ) — Impact of CARES Act (1,700 ) — — Other 56 28 54 Income tax benefit $ (2,577 ) $ (34 ) $ (3,075 ) (1) Includes non-deductible stock-based compensation. |
Schedule of Deferred Income Taxes | The components of deferred income taxes consisted of the following and result from differences in the recognition of transactions for income tax and financial reporting purposes: September 30, (In thousands) 2020 2019 Depreciable assets $ (1,964 ) $ (905 ) Deferred revenue 2,029 1,554 Accruals and reserves 1,858 585 Stock-based compensation 2,232 2,213 Impaired strategic investments 1,767 1,666 NOL carryforwards 3,526 3,308 U.S. Federal and State R&D credits 3,216 2,394 Other 897 689 Valuation allowance (6,246 ) (5,328 ) Total deferred tax assets $ 7,315 $ 6,176 |
Summary of Reconciliation of Changes in Unrecognized Tax Benefits | Unrecognized tax benefits are the differences between a tax position taken, or expected to be taken in a tax return, and the benefit recognized for accounting purposes pursuant to accounting guidance. The following is a reconciliation of the changes in unrecognized tax benefits, excluding interest and penalties: Fiscal Year (In thousands) 2020 2019 2018 Unrecognized tax benefits, beginning balance $ 2,323 $ 1,559 $ 1,481 Increases in tax positions for prior years 58 278 61 Decreases in tax positions for prior years (1 ) (2 ) — Increases in tax positions for current year 664 735 735 Settlements with taxing authorities — — (613 ) Lapse of the statute of limitations (173 ) (247 ) (105 ) Unrecognized tax benefits, ending balance $ 2,871 $ 2,323 $ 1,559 |
Reportable Segment Information
Reportable Segment Information (Tables) | 12 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Segment Revenue, Operating (Loss) Income and Depreciation and Amortization | Segment revenue, operating (loss) income, and depreciation and amortization were as follows: Fiscal Year (In thousands) 2020 2019 2018 Revenue: Medical Device $ 71,401 $ 78,353 $ 60,513 In Vitro Diagnostics 23,463 21,724 20,823 Total revenue $ 94,864 $ 100,077 $ 81,336 Operating (loss) income: Medical Device $ (3,246 ) $ 4,794 $ (8,478 ) In Vitro Diagnostics 11,771 10,620 8,619 Total segment operating (loss) income 8,525 15,414 141 Corporate (9,776 ) (8,945 ) (8,940 ) Total operating (loss) income $ (1,251 ) $ 6,469 $ (8,799 ) Depreciation and amortization: Medical Device $ 6,223 $ 5,811 $ 5,376 In Vitro Diagnostics 483 464 394 Corporate 557 1,037 661 Total depreciation and amortization $ 7,263 $ 7,312 $ 6,431 |
Revenue from Customers | Revenue from customers that equaled or exceeded 10% of total revenue was as follows: Fiscal Year 2020 2019 2018 Abbott 19 % 19 % 11 % Medtronic 14 % 14 % 16 % |
Geographic Revenue and Long-lived Assets | Revenue by geographic region was as follows: Fiscal Year 2020 2019 2018 Domestic 78 % 81 % 79 % Foreign 22 % 19 % 21 % Long-lived assets by country, including property and equipment and intangible assets net of accumulated depreciation and amortization, respectively, were as follows: September 30, (In thousands) 2020 2019 U.S. $ 25,273 $ 24,450 Ireland 18,113 19,524 |
Quarterly Financial Data (Una_2
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Sep. 30, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Unaudited Quarterly Results | The following is a summary of the unaudited quarterly results: (In thousands, except per share data) First Quarter Second Quarter Third Quarter Fourth Quarter Fiscal Year 2020 Total revenue $ 22,616 $ 22,822 $ 26,883 $ 22,543 Operating (loss) income (266 ) (156 ) 1,164 (1,993 ) Net income (loss) 148 1,462 2,459 (2,946 ) Basic net income (loss) per share (1): 0.01 0.11 0.18 (0.22 ) Diluted net income (loss) per share (1): 0.01 0.11 0.18 (0.22 ) Fiscal Year 2019 Total revenue $ 22,241 $ 22,676 $ 24,344 $ 30,816 Operating income 712 865 1,017 3,875 Net income 1,310 1,262 1,466 3,554 Basic net income per share (1): 0.10 0.09 0.11 0.27 Diluted net income per share (1): 0.09 0.09 0.11 0.26 (1) The sum of the quarterly net income (loss) per share amounts may not equal the annual income per share total because of changes in the weighted average number of shares outstanding that occurred during the year. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Select Balance Sheet Information - Additional Information (Detail) - USD ($) shares in Millions | 3 Months Ended | 12 Months Ended | ||||||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | Oct. 01, 2019 | |
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
AFS investments net unrealized loss reclassified out of accumulated other comprehensive income (loss) with a corresponding adjustment to other income (loss) | $ 0 | $ 0 | $ 0 | |||||||||
Held-to-maturity debt securities | $ 0 | $ 0 | 0 | 0 | ||||||||
Realized gains or losses on sales of available-for-sale securities | 0 | 0 | 0 | |||||||||
Depreciation expense | 4,800,000 | 4,700,000 | 3,700,000 | |||||||||
Amortization expense | 2,500,000 | 2,600,000 | 2,700,000 | |||||||||
Impairment loss | 0 | 0 | ||||||||||
Goodwill impairment charges | 0 | 0 | 0 | |||||||||
Impairment charges relating to long-lived assets | 0 | 0 | 0 | |||||||||
Revenue | 22,543,000 | $ 26,883,000 | $ 22,822,000 | $ 22,616,000 | 30,816,000 | $ 24,344,000 | $ 22,676,000 | $ 22,241,000 | 94,864,000 | 100,077,000 | 81,336,000 | |
Income tax (benefit) provision | $ (2,577,000) | $ (34,000) | $ (3,075,000) | |||||||||
Antidilutive options excluded from computation of EPS | 0.1 | 0.2 | 1 | |||||||||
ASC Topic 842 adoption, right-of-use asset | 2,508,000 | $ 2,508,000 | ||||||||||
ASC Topic 842 adoption, lease liability | 3,776,000 | 3,776,000 | ||||||||||
Deferred rent liability | 1,200,000 | 1,200,000 | ||||||||||
Abbott Agreement [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Revenue | 12,000,000 | $ 13,500,000 | $ 4,400,000 | |||||||||
Collaborative arrangement payment received | 45,800,000 | |||||||||||
Collaborative arrangement additional potential milestone payments receivable | 45,000,000 | 45,000,000 | ||||||||||
Abbott Agreement [Member] | Upfront Payment [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Collaborative arrangement payment received | 25,000,000 | |||||||||||
Abbott Agreement [Member] | Milestone Payment [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Collaborative arrangement payment received | $ 10,800,000 | 10,000,000 | $ 10,800,000 | 10,000,000 | ||||||||
Abbott Agreement [Member] | TRANSCEND Clinical Trial [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Clinical study completion period | 5 years | |||||||||||
Abbott Agreement [Member] | Clinical Trial Report Milestone [Member] | TRANSCEND Clinical Trial [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Collaborative arrangement additional potential milestone payments receivable | 15,000,000 | $ 15,000,000 | ||||||||||
Abbott Agreement [Member] | PMA Milestone [Member] | TRANSCEND Clinical Trial [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Collaborative arrangement additional potential milestone payments receivable | $ 30,000,000 | 30,000,000 | ||||||||||
IDA [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Reimbursement recorded as reduction to R&D expense | $ 800,000 | $ 700,000 | $ 800,000 | |||||||||
Revenue [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Performance obligations, payment terms, royalties | 45 days | |||||||||||
Revenue [Member] | Customer Concentration Risk [Member] | Abbott [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Percentage of consolidated revenue | 19.00% | 19.00% | 11.00% | |||||||||
Revenue [Member] | Customer Concentration Risk [Member] | Medtronic [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Percentage of consolidated revenue | 14.00% | 14.00% | 16.00% | |||||||||
Revenue [Member] | Product Concentration Risk | Abbott Agreement [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Percentage of consolidated revenue | 13.00% | 13.00% | 5.00% | |||||||||
ASC Topic 842 [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
ASC Topic 842 adoption, right-of-use asset | $ 1,700,000 | |||||||||||
ASC Topic 842 adoption, lease liability | $ 2,900,000 | |||||||||||
Impact of Adoption [Member] | Adoption of ASC Topic 606 [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Revenue | $ 1,300,000 | |||||||||||
Income tax (benefit) provision | 300,000 | |||||||||||
Leases [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Lease description | The Company leases facilities for research, office, manufacturing and warehousing. | |||||||||||
Lease, existence of option to extend | true | |||||||||||
Lease, option to extend | The Company’s leases include one or more options to renew and extend the lease term at the Company’s discretion. These renewal options are not included in right-of-use assets and lease liabilities as they are not reasonably certain of exercise. | |||||||||||
Operating lease cost | $ 600,000 | |||||||||||
Rent expense related to operating leases | 500,000 | $ 500,000 | ||||||||||
Weighted average remaining lease term for operating leases | 7 years 3 months 18 days | 7 years 3 months 18 days | ||||||||||
Weighted average discount rate used to determine operating lease liabilities | 4.00% | 4.00% | ||||||||||
Research and development expense [Member] | In-Process Research and Development [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Impairment loss | 300,000 | |||||||||||
ViaCyte, Inc. [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Original cost of investment | $ 5,300,000 | $ 5,300,000 | ||||||||||
Other-than-temporary impairment loss on investment | $ 500,000 | 500,000 | 4,800,000 | |||||||||
Carrying amount of investment | $ 0 | $ 500,000 | $ 0 | $ 500,000 | ||||||||
Maximum [Member] | Revenue [Member] | Customer Concentration Risk [Member] | Medtronic [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Percentage of consolidated revenue | 5.00% | |||||||||||
Maximum [Member] | Revenue [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Performance obligations, payment terms, product sales | 45 days | |||||||||||
Performance obligations, payment terms, R&D services | 45 days | |||||||||||
Maximum [Member] | ViaCyte, Inc. [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Company's ownership percentage | 1.00% | 1.00% | ||||||||||
Minimum [Member] | Revenue [Member] | ||||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||||
Performance obligations, payment terms, product sales | 30 days | |||||||||||
Performance obligations, payment terms, R&D services | 30 days |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies and Select Balance Sheet Information - Amortized Cost, Unrealized Holding Gains and (Losses) and Fair Value of Available-for-sale Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 30,313 | $ 24,918 |
Unrealized Gains | 19 | 13 |
Unrealized Losses | (19) | |
Fair Value | 30,313 | 24,931 |
Commercial paper and corporate bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 30,313 | 24,918 |
Unrealized Gains | 19 | 13 |
Unrealized Losses | (19) | |
Fair Value | $ 30,313 | $ 24,931 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies and Select Balance Sheet Information - Components of Inventories (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 3,758 | $ 2,034 |
Work-in process | 817 | 892 |
Finished products | 1,391 | 1,575 |
Total | $ 5,966 | $ 4,501 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies and Select Balance Sheet Information - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Less: Accumulated depreciation | $ (42,962) | $ (37,989) |
Property and equipment, net | 30,103 | 29,748 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | 4,419 | 4,415 |
Laboratory Fixtures and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | $ 28,600 | 25,467 |
Laboratory Fixtures and Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 3 years | |
Laboratory Fixtures and Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 12 years | |
Building and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | $ 25,638 | 24,513 |
Building and Improvements [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 3 years | |
Building and Improvements [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 20 years | |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | $ 4,836 | 4,836 |
Leasehold Improvements [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 3 years | |
Leasehold Improvements [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 10 years | |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | $ 7,334 | 6,476 |
Office Furniture and Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 3 years | |
Office Furniture and Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Useful Life | 10 years | |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | $ 2,238 | $ 2,030 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies and Select Balance Sheet Information - Summary of Other Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 |
Schedule of Investments [Line Items] | ||
Other assets, net | $ 4,269 | $ 2,124 |
ViaCyte, Inc. [Member] | ||
Schedule of Investments [Line Items] | ||
Other assets, net | 479 | |
Operating Lease Right-of-Use Assets [Member] | ||
Schedule of Investments [Line Items] | ||
Other assets, net | 2,508 | |
Other Noncurrent Assets [Member] | ||
Schedule of Investments [Line Items] | ||
Other assets, net | $ 1,761 | $ 1,645 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies and Select Balance Sheet Information - Schedule of Intangible Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Accumulated Amortization | $ (18,746) | $ (15,769) |
Intangible assets, Gross Carrying Amount | 32,029 | 29,995 |
Intangible assets, Net | $ 13,283 | $ 14,226 |
Customer Lists and Relationships [Member] | ||
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Weighted Average Original Life (Years) | 8 years 10 months 24 days | 8 years 10 months 24 days |
Definite-lived intangible assets, Gross Carrying Amount | $ 18,213 | $ 17,374 |
Definite-lived intangible assets, Accumulated Amortization | (12,451) | (10,661) |
Definite-lived intangible assets, Net | $ 5,762 | $ 6,713 |
Developed Technology [Member] | ||
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Weighted Average Original Life (Years) | 11 years 6 months | 11 years 6 months |
Definite-lived intangible assets, Gross Carrying Amount | $ 9,685 | $ 9,490 |
Definite-lived intangible assets, Accumulated Amortization | (4,200) | (3,196) |
Definite-lived intangible assets, Net | $ 5,485 | $ 6,294 |
Non-compete [Member] | ||
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Weighted Average Original Life (Years) | 5 years | 5 years |
Definite-lived intangible assets, Gross Carrying Amount | $ 230 | $ 230 |
Definite-lived intangible assets, Accumulated Amortization | $ (230) | (196) |
Definite-lived intangible assets, Net | $ 34 | |
Patents and Other [Member] | ||
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Weighted Average Original Life (Years) | 14 years 8 months 12 days | 16 years 6 months |
Definite-lived intangible assets, Gross Carrying Amount | $ 3,321 | $ 2,321 |
Definite-lived intangible assets, Accumulated Amortization | (1,865) | (1,716) |
Definite-lived intangible assets, Net | 1,456 | 605 |
Definite-Lived Intangible Assets [Member] | ||
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Gross Carrying Amount | 31,449 | 29,415 |
Definite-lived intangible assets, Accumulated Amortization | (18,746) | (15,769) |
Definite-lived intangible assets, Net | 12,703 | 13,646 |
Trademarks and Trade Names [Member] | ||
Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets, Net | $ 580 | $ 580 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies and Select Balance Sheet Information - Estimated Amortization Expense (Detail) $ in Thousands | Sep. 30, 2020USD ($) |
Goodwill And Intangible Assets Disclosure [Abstract] | |
2021 | $ 2,488 |
2022 | 2,448 |
2023 | 1,843 |
2024 | 1,750 |
2025 | $ 1,712 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies and Select Balance Sheet Information - Schedule Of Carrying Amount of Goodwill by Reportable Segment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Goodwill [Line Items] | ||
Beginning Balance | $ 26,171 | $ 27,032 |
Foreign currency translation adjustment | 1,014 | (861) |
Ending Balance | 27,185 | 26,171 |
In Vitro Diagnostics [Member] | ||
Goodwill [Line Items] | ||
Beginning Balance | 8,010 | 8,010 |
Ending Balance | 8,010 | 8,010 |
Medical Device [Member] | ||
Goodwill [Line Items] | ||
Beginning Balance | 18,161 | 19,022 |
Foreign currency translation adjustment | 1,014 | (861) |
Ending Balance | $ 19,175 | $ 18,161 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies and Select Balance Sheet Information - Schedule of Accrued Other Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 |
Accrued Liabilities Current [Abstract] | ||
Accrued professional fees | $ 239 | $ 434 |
Accrued clinical study expense | 2,206 | 2,163 |
Accrued purchases | 647 | 679 |
Acquisition of in-process research and development and intangible assets | 1,148 | 989 |
Due to customers | 321 | 19 |
Construction-in-progress | 272 | |
Operating lease liability, current portion | 436 | |
Deferred rent, current portion | 130 | |
Other | 278 | 376 |
Total accrued other liabilities | $ 5,547 | $ 4,790 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies and Select Balance Sheet Information - Impact of Adoption of ASC Topic 606 on Consolidated Balance Sheet (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 | Oct. 01, 2018 | Sep. 30, 2018 |
Assets | ||||
Contract assets — royalties and license fees | $ 6,108 | $ 8,210 | ||
Deferred income taxes | 7,315 | 6,176 | $ 6,304 | |
Income tax receivable | 2,391 | 558 | 1,152 | |
Liabilities and Stockholders' Equity | ||||
Deferred revenue, current portion | 9,646 | |||
Deferred revenue, less current portion | 11,247 | |||
Retained earnings | $ 111,828 | $ 110,705 | $ 97,615 | |
Adoption of ASC Topic 606 [Member] | ||||
Assets | ||||
Contract assets — royalties and license fees | $ 6,904 | |||
Deferred income taxes | 5,089 | |||
Income tax receivable | 762 | |||
Liabilities and Stockholders' Equity | ||||
Deferred revenue, current portion | 9,628 | |||
Deferred revenue, less current portion | 11,066 | |||
Retained earnings | 103,113 | |||
Adjustments | Adoption of ASC Topic 606 [Member] | ||||
Assets | ||||
Contract assets — royalties and license fees | 6,904 | |||
Deferred income taxes | (1,215) | |||
Income tax receivable | (390) | |||
Liabilities and Stockholders' Equity | ||||
Deferred revenue, current portion | (18) | |||
Deferred revenue, less current portion | (181) | |||
Retained earnings | $ 5,498 |
Summary of Significant Accou_14
Summary of Significant Accounting Policies and Select Balance Sheet Information - Additional Information (Detail 1) | 12 Months Ended |
Sep. 30, 2020 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2020-10-01 | |
Summary Of Significant Accounting Policies [Line Items] | |
Remaining performance obligation, expected timing of satisfaction, period | five years |
Remaining performance obligation, expected timing of satisfaction, percentage | 76.00% |
Revenue remaining performance obligation expected timing of satisfaction period | 1 year |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2021-10-01 | |
Summary Of Significant Accounting Policies [Line Items] | |
Remaining performance obligation, expected timing of satisfaction, period | four years |
Remaining performance obligation, expected timing of satisfaction, percentage | 24.00% |
Summary of Significant Accou_15
Summary of Significant Accounting Policies and Select Balance Sheet Information - Additional Information (Detail 2) $ in Millions | Sep. 30, 2020USD ($) |
Accounting Policies [Abstract] | |
Remaining performance obligation, amount | $ 15.9 |
Summary of Significant Accou_16
Summary of Significant Accounting Policies and Select Balance Sheet Information - Denominator for Computation of Basic and Diluted Net Income (Loss) Per Share (Detail) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |||
Net income (loss) available to common shareholders | $ 1,123 | $ 7,592 | $ (4,457) |
Basic weighted average shares outstanding | 13,552 | 13,389 | 13,157 |
Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units | 260 | 390 | |
Diluted weighted average shares outstanding | 13,812 | 13,779 | 13,157 |
Summary of Significant Accou_17
Summary of Significant Accounting Policies and Select Balance Sheet Information - Balance Sheet Classification and Amounts of Right-of-Use Assets and Lease Liabilities (Detail) $ in Thousands | Sep. 30, 2020USD ($) |
Right-of-use assets: | |
Other assets | $ 2,508 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent |
Operating lease liabilities: | |
Other accrued liabilities | $ 436 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherAccruedLiabilitiesCurrent |
Other long-term liabilities | $ 3,340 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent |
Total operating lease liabilities | $ 3,776 |
Summary of Significant Accou_18
Summary of Significant Accounting Policies and Select Balance Sheet Information - Schedule of Operating Lease Maturities (Detail) $ in Thousands | Sep. 30, 2020USD ($) |
Operating Lease Liabilities Payments Due [Abstract] | |
2021 | $ 586 |
2022 | 612 |
2023 | 625 |
2024 | 638 |
2025 | 651 |
Thereafter | 1,521 |
Total expected operating lease payments | 4,633 |
Less: Imputed interest | (857) |
Total operating lease liabilities | $ 3,776 |
Revenue - Summary of Revenues D
Revenue - Summary of Revenues Disaggregated by Product Classification and Reportable Segment (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | $ 22,543 | $ 26,883 | $ 22,822 | $ 22,616 | $ 30,816 | $ 24,344 | $ 22,676 | $ 22,241 | $ 94,864 | $ 100,077 | $ 81,336 |
Product Sales [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 44,317 | 40,219 | 37,953 | ||||||||
Royalties [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 40,634 | 48,458 | 35,424 | ||||||||
Research, Development and Other [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 9,913 | 11,400 | 7,959 | ||||||||
Operating Segments [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 94,864 | 100,077 | 81,336 | ||||||||
Operating Segments [Member] | Medical Device [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 71,401 | 78,353 | 60,513 | ||||||||
Operating Segments [Member] | Medical Device [Member] | Product Sales [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 21,608 | 18,617 | 17,200 | ||||||||
Operating Segments [Member] | Medical Device [Member] | Royalties [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 28,614 | 34,781 | 30,606 | ||||||||
Operating Segments [Member] | Medical Device [Member] | License Fees [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 12,020 | 13,678 | 4,818 | ||||||||
Operating Segments [Member] | Medical Device [Member] | Research, Development and Other [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 9,159 | 11,277 | 7,889 | ||||||||
Operating Segments [Member] | In Vitro Diagnostics [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 23,463 | 21,724 | 20,823 | ||||||||
Operating Segments [Member] | In Vitro Diagnostics [Member] | Product Sales [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 22,709 | 21,390 | 20,789 | ||||||||
Operating Segments [Member] | In Vitro Diagnostics [Member] | Other [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | $ 754 | $ 334 | $ 34 |
Collaborative Arrangement - Add
Collaborative Arrangement - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Total revenue | $ 22,543,000 | $ 26,883,000 | $ 22,822,000 | $ 22,616,000 | $ 30,816,000 | $ 24,344,000 | $ 22,676,000 | $ 22,241,000 | $ 94,864,000 | $ 100,077,000 | $ 81,336,000 |
Abbott Agreement [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaborative arrangement payment received | 45,800,000 | ||||||||||
Collaborative arrangement additional potential milestone payments receivable | 45,000,000 | 45,000,000 | |||||||||
Total revenue | 12,000,000 | 13,500,000 | 4,400,000 | ||||||||
Upfront and milestone fee payment included in deferred revenue | 15,900,000 | 17,100,000 | 15,900,000 | 17,100,000 | |||||||
Collaboration revenue recognized included in balance at beginning of period | 5,000,000 | 8,400,000 | |||||||||
Abbott Agreement [Member] | Contract Life to Date [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Total revenue | 29,900,000 | ||||||||||
Abbott Agreement [Member] | Upfront Payment [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaborative arrangement payment received | $ 25,000,000 | ||||||||||
Abbott Agreement [Member] | Milestone Payment [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaborative arrangement payment received | $ 10,800,000 | $ 10,000,000 | 10,800,000 | $ 10,000,000 | |||||||
Abbott Agreement [Member] | Clinical Trial Report Milestone [Member] | TRANSCEND Clinical Trial [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaborative arrangement additional potential milestone payments receivable | 15,000,000 | 15,000,000 | |||||||||
Abbott Agreement [Member] | PMA Milestone [Member] | TRANSCEND Clinical Trial [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Collaborative arrangement additional potential milestone payments receivable | $ 30,000,000 | $ 30,000,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | 12 Months Ended | |||
Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2018EUR (€) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Transfers in or out Level 3, Assets | $ 0 | $ 0 | ||
Transfers in or out Level 3, Liabilities | 0 | 0 | ||
Contingent consideration liability | $ 14,500,000 | |||
Contingent consideration liability, noncurrent | 3,400,000 | |||
NorMedix [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Contingent consideration liability | $ 3,200,000 | |||
Creagh Medical Ltd [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Contingent consideration liability | 11,000,000 | $ 11,000,000 | € 9,600,000 | |
Creagh Medical Ltd [Member] | Minimum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Percentage of Probability Achievement of Contingent Consideration payment. | 5.00% | |||
Creagh Medical Ltd [Member] | Maximum [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Percentage of Probability Achievement of Contingent Consideration payment. | 95.00% | |||
Creagh Medical Ltd [Member] | Contingent Consideration [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Foreign currency gains | $ 100,000 | $ 100,000 | ||
Creagh Medical Ltd [Member] | Contingent Consideration [Member] | Revenue Based Milestones [Member] | Discount Rate [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Fair value measurement inputs | 20.5 | 20.5 | ||
Creagh Medical Ltd [Member] | Contingent Consideration [Member] | Non Revenue Based Milestones | Discount Rate [Member] | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Fair value measurement inputs | 6 | 2.3 | 2.3 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Assets and Liabilities Measured at Fair Value on a Recurring Basis [Member] - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | $ 48,947 | $ 49,306 |
Liabilities measured at fair value | 3,200 | |
Available-for-sale securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | 30,313 | 24,931 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | 48,947 | 49,306 |
Significant Other Observable Inputs (Level 2) [Member] | Available-for-sale securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | 30,313 | 24,931 |
Level 3 Liabilities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Liabilities measured at fair value | 3,200 | |
Cash equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | 18,634 | 24,375 |
Cash equivalents [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | $ 18,634 | 24,375 |
Contingent consideration [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Liabilities measured at fair value | 3,200 | |
Contingent consideration [Member] | Level 3 Liabilities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Liabilities measured at fair value | $ 3,200 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Contingent Consideration Liabilities Measured at Fair Value (Detail) - Contingent Consideration [Member] - Significant Unobservable Inputs (Level 3) [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Contingent consideration liability, beginning balance | $ 3,200 | $ 14,466 |
Fair value adjustments | (415) | |
Settlements | $ (3,200) | (10,979) |
Interest accretion | 254 | |
Foreign currency translation | (126) | |
Contingent consideration liability, ending balance | $ 3,200 |
Debt - Additional Information (
Debt - Additional Information (Details) - Secured Revolving Credit Facility [Member] - Loan and Security Agreement [Member] | 12 Months Ended |
Sep. 30, 2020USD ($) | |
Line Of Credit Facility [Line Items] | |
Revolving credit facility, maximum borrowing capacity | $ 25,000,000 |
Revolving credit facility, outstanding balance | $ 0 |
Revolving credit facility, borrowing base | Availability under the Loan is subject to a borrowing base that equals 80% of the margin value of securities collateral that has been pledged to the Bank. |
Revolving credit facility, maturity date | Sep. 14, 2021 |
Debt instrument, maturity date, description | maturity date may be extended by the Company for up to two extension periods of twelve months subject to certain conditions set forth in the Loan Agreement. |
Revolving credit facility, interest rate | Interest under the Loan Agreement accrues at a rate per annum equal to the greater of (i) 3.25% per annum and (ii) the 90-day interest rate yield for U.S. Government Treasury Securities plus 2.75% per annum. |
Revolving credit facility, basis spread on variable rate | 2.75% |
Revolving credit facility, unused commitment fee rate | 0.075% |
Revolving credit facility, frequency of payments | quarterly |
Minimum [Member] | |
Line Of Credit Facility [Line Items] | |
Revolving credit facility, interest rate | 3.25 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Sep. 30, 2020 | Nov. 06, 2015 | Nov. 05, 2014 |
Stockholders Equity [Line Items] | |||
Remaining amount available for repurchases of shares | $ 25,300,000 | ||
Accelerated Share Repurchase Program [Member] | |||
Stockholders Equity [Line Items] | |||
Maximum payments for repurchase of common stock | $ 20,000,000 | $ 30,000,000 |
Stock-based Compensation Plan_2
Stock-based Compensation Plans - Stock-based Compensation Expenses (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 5,453 | $ 5,077 | $ 4,807 |
Product costs [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 119 | 135 | 69 |
Research and development [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 896 | 876 | 801 |
Selling, general and administrative [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 4,438 | $ 4,066 | $ 3,937 |
Stock-based Compensation Plan_3
Stock-based Compensation Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock-Based Compensation Activity [Line Items] | |||||
Unrecognized compensation costs, nonvested awards, amount | $ 7,400,000 | ||||
Unrecognized compensation costs, nonvested awards, weighted average recognition period | 2 years 2 months 12 days | ||||
Stock-based compensation expense | $ 5,453,000 | $ 5,077,000 | $ 4,807,000 | ||
Dividend yield | 0.00% | ||||
Nonqualified Stock Options [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Expiration period | 7 years | ||||
Stock-based compensation expense | $ 2,500,000 | 2,200,000 | 1,600,000 | ||
Aggregate intrinsic value, outstanding options | 6,800,000 | ||||
Aggregate intrinsic value, exercisable options | $ 5,800,000 | ||||
Weighted average remaining contractual life, options outstanding | 4 years 3 months 18 days | ||||
Weighted average remaining contractual remaining, options exercisable | 3 years 2 months 12 days | ||||
Intrinsic value, options exercised | $ 2,000,000 | 300,000 | 12,100,000 | ||
Nonqualified Stock Options [Member] | Employee [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting period | 4 years | ||||
Nonqualified Stock Options [Member] | Maximum [Member] | Director [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting period | 1 year | ||||
Restricted Stock Awards [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting period | 3 years | ||||
Stock-based compensation expense | $ 2,000,000 | 1,700,000 | $ 1,000,000 | ||
Weighted average grant date fair value | $ 3,900,000 | $ 4,000,000 | |||
Units granted | 67,000 | 45,000 | 56,000 | ||
Units outstanding | 100,000 | 90,000 | 85,000 | 68,000 | |
Restricted Stock Units (RSUs) [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting period | 3 years | ||||
Stock-based compensation expense | $ 600,000 | $ 600,000 | $ 500,000 | ||
Weighted average grant date fair value | $ 2,500,000 | $ 2,800,000 | |||
Units granted | 18,000 | 12,000 | 22,000 | ||
Units outstanding | 65,000 | 62,000 | |||
Deferred Stock Units [Member] | Director [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Stock-based compensation expense | $ 100,000 | $ 100,000 | $ 100,000 | ||
Weighted average grant date fair value | $ 1,300,000 | $ 1,400,000 | |||
Units outstanding | 33,000 | 30,000 | |||
Performance Shares [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting period | 3 years | 3 years | |||
Performance Shares [Member] | Fiscal 2017 (2017 - 2019) [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Fair value of stock units granted | $ 1,200,000 | ||||
Performance Shares [Member] | Maximum [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Stock-based compensation expense | $ 100,000 | $ 400,000 | 1,500,000 | ||
1999 Employee Stock Purchase Plan [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Stock-based compensation expense | 200,000 | 100,000 | $ 100,000 | ||
Annual compensation withheld, maximum limit | 25,000 | ||||
Employee contributions in accrued compensation at period end | $ 100,000 | $ 100,000 | |||
1999 Employee Stock Purchase Plan [Member] | Maximum [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Common stock authorized, original authorization | 600,000 | ||||
Annual compensation withheld | 10.00% | ||||
Vesting Anniversary [Member] | Nonqualified Stock Options [Member] | Employee [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting percentage | 25.00% | ||||
Vesting Anniversary [Member] | Restricted Stock Awards [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting percentage | 33.00% | ||||
Vesting Anniversary [Member] | Restricted Stock Units (RSUs) [Member] | Employee [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Vesting percentage | 33.00% | ||||
2019 Equity Incentive Plan [Member] | |||||
Stock-Based Compensation Activity [Line Items] | |||||
Common stock authorized, original authorization | 1,100,000 | ||||
Common stock authorized, shares remaining | 839,000 |
Stock-based Compensation Plan_4
Stock-based Compensation Plans - Stock Option Fair Value Assumptions and Weighted Average Fair Value of Stock Options Granted (Detail) - $ / shares | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock option fair value assumptions: | |||
Risk-free interest rates | 1.41% | 2.75% | 2.18% |
Expected life (years) | 4 years 7 months 6 days | 4 years 6 months | 4 years 9 months 18 days |
Expected volatility | 39.00% | 34.00% | 33.00% |
Dividend yield | 0.00% | ||
Weighted average grant date fair value of stock options granted | $ 14.13 | $ 17.89 | $ 10.91 |
Stock-based Compensation Plan_5
Stock-based Compensation Plans - Schedule of Stock Option Activity (Detail) - $ / shares | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Number of Options Outstanding, Beginning balance | 871,000 | 711,000 | 1,002,000 |
Number of Options, Granted | 299,000 | 179,000 | 270,000 |
Number of Options, Exercised | (125,000) | (13,000) | (450,000) |
Number of Options, Forfeited and expired | (105,000) | (6,000) | (111,000) |
Number of Options Outstanding, Ending balance | 940,000 | 871,000 | 711,000 |
Number of Options, vested and exercisable | 472,000 | ||
Weighted Average Exercise Price, Beginning Balance | $ 32.18 | $ 26.28 | $ 21.54 |
Weighted Average Exercise Price, Granted | 41.06 | 55.09 | 34.08 |
Weighted Average Exercise Price, Exercised | 22.89 | 22.03 | 19.46 |
Weighted Average Exercise Price, Forfeited and expired | 41.69 | 42.28 | 30.18 |
Weighted Average Exercise Price, Ending balance | 35.18 | $ 32.18 | $ 26.28 |
Weighted Average Exercise Price, vested and exercisable | $ 28.65 |
Stock-based Compensation Plan_6
Stock-based Compensation Plans - Schedule of Restricted Stock Activity (Detail) - Restricted Stock Awards [Member] - $ / shares | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of Units, Beginning balance | 90,000 | 85,000 | 68,000 |
Number of Units, Granted | 67,000 | 45,000 | 56,000 |
Number of Units, Vested | (43,000) | (39,000) | (29,000) |
Number of Units, Forfeited | (14,000) | (1,000) | (10,000) |
Number of Units, Ending balance | 100,000 | 90,000 | 85,000 |
Weighted Average Grant Date Fair Value, Beginning balance | $ 43.69 | $ 30.30 | $ 23.98 |
Weighted Average Grant Date Fair Value, Granted | 41.40 | 56.05 | 34.38 |
Weighted Average Grant Date Fair Value, Vested | 38.74 | 28.61 | 23.78 |
Weighted Average Grant Date Fair Value, Forfeited | 44.76 | 47.86 | 29.10 |
Weighted Average Grant Date Fair Value, Ending balance | $ 44.16 | $ 43.69 | $ 30.30 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Current (benefit) provision: | |||
U.S. Federal | $ (1,570) | $ 1,355 | $ (890) |
U.S. State | 42 | 192 | 51 |
International | 90 | 41 | 41 |
Total current (benefit) provision | (1,438) | 1,588 | (798) |
Deferred (benefit) provision: | |||
U.S. Federal | (1,336) | (1,505) | (2,006) |
U.S. State | 197 | (117) | (271) |
Total deferred benefit | (1,139) | (1,622) | (2,277) |
Total income tax benefit | $ (2,577) | $ (34) | $ (3,075) |
Income Taxes - Schedule of In_2
Income Taxes - Schedule of Income Taxes (Parenthetical) (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 | Oct. 01, 2018 | Sep. 30, 2018 |
Income Tax Disclosure [Line Items] | ||||
Deferred income taxes | $ 7,315 | $ 6,176 | $ 6,304 | |
Income tax receivable | $ (2,391) | $ (558) | $ (1,152) | |
Adoption of ASC Topic 606 [Member] | ||||
Income Tax Disclosure [Line Items] | ||||
Deferred income taxes | $ 5,089 | |||
Income tax receivable | (762) | |||
Impact of Adoption [Member] | Adoption of ASC Topic 606 [Member] | ||||
Income Tax Disclosure [Line Items] | ||||
Deferred income taxes | (1,215) | |||
Income tax receivable | $ 390 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Line Items] | |||||
U.S. federal statutory tax rate | 35.00% | 21.00% | 21.00% | 24.50% | 35.00% |
Impact of CARES Act | $ 1,700,000 | ||||
Discrete tax impact of enacted tax legislation | $ 1,600,000 | ||||
Excess tax benefits related to stock based compensation expense | 400,000 | $ 500,000 | 2,000,000 | ||
Deferred tax asset valuation allowance | 6,246,000 | 5,328,000 | |||
Unrecognized tax benefits that would impact effective tax rate | 2,700,000 | 2,100,000 | 1,400,000 | ||
Accrued interest and penalties on unrecognized tax benefits | 600,000 | 500,000 | $ 400,000 | ||
Undistributed earnings in foreign subsidiaries | 0 | $ 0 | |||
Federal [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Net operating loss carryforwards | $ 100,000 | ||||
Net operating loss carryforwards, beginning of expiration year | 2034 | ||||
State [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Net operating loss carryforwards | $ 200,000 | ||||
Net operating loss carryforwards, beginning of expiration year | 2022 | ||||
Ireland and Luxembourg [Member] | Creagh Medical Ltd [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Net operating loss carryforwards | $ 3,200,000 | ||||
R&D Credit Carryforwards [Member] | Federal and State [Member] | 2029 [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Tax credit carryforwards | $ 3,200,000 | ||||
Tax credit carryforward, beginning of expiration year | 2029 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation Difference of Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |||
Amount at statutory U.S. federal income tax rate | $ (305) | $ 1,587 | $ (1,845) |
Change because of the following items: | |||
State income taxes, net of federal benefit | (551) | (452) | (724) |
U.S. Federal and foreign research and development credits | (1,571) | (2,464) | (1,710) |
Foreign and state rate differential | 212 | 156 | 371 |
Valuation allowance change | 825 | 671 | 960 |
Stock-based compensation | (81) | (163) | (2,063) |
Contingent consideration (gain) expense and related foreign currency revaluation | (61) | 142 | |
U.S. Federal and state rate change | 17 | 44 | 1,582 |
Tax reserve change | 609 | 770 | 158 |
Foreign-derived income deduction | (88) | (150) | |
Impact of CARES Act | (1,700) | ||
Other | 56 | 28 | 54 |
Total income tax benefit | $ (2,577) | $ (34) | $ (3,075) |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Income Taxes (Detail) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 |
Income Tax Disclosure [Abstract] | |||
Depreciable assets | $ (1,964) | $ (905) | |
Deferred revenue | 2,029 | 1,554 | |
Accruals and reserves | 1,858 | 585 | |
Stock-based compensation | 2,232 | 2,213 | |
Impaired strategic investments | 1,767 | 1,666 | |
NOL carryforwards | 3,526 | 3,308 | |
U.S. Federal and State R&D credits | 3,216 | 2,394 | |
Other | 897 | 689 | |
Valuation allowance | (6,246) | (5,328) | |
Total deferred tax assets | $ 7,315 | $ 6,176 | $ 6,304 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Changes in Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |||
Unrecognized tax benefits, beginning balance | $ 2,323 | $ 1,559 | $ 1,481 |
Increases in tax positions for prior years | 58 | 278 | 61 |
Decreases in tax positions for prior years | (1) | (2) | |
Increases in tax positions for current year | 664 | 735 | 735 |
Settlements with taxing authorities | (613) | ||
Lapse of the statute of limitations | (173) | (247) | (105) |
Unrecognized tax benefits, ending balance | $ 2,871 | $ 2,323 | $ 1,559 |
Defined Contribution Plans - Ad
Defined Contribution Plans - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Contributions to defined contribution plans | $ 1 | $ 0.9 | $ 0.7 |
U.S. [Member] | 401 (K) Retirement and Savings Plan [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Percentage of employee contributions, eligible for employer match | 50.00% | ||
Percentage of employee contributions | 6.00% | ||
Ireland [Member] | Defined Contribution PRSA Plan [Member] | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Percentage of employee contributions, eligible for employer match | 6.00% | ||
Percentage of employee contributions | 8.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | 48 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2024 | |
Commitments And Contingencies [Line Items] | |||||
Payments to acquire in-process research and development | $ 750,000 | $ 5,000,000 | |||
Acquisition charge for in-process of research and development | 890,000 | 7,888,000 | |||
Other accrued liabilities current | $ 4,790,000 | $ 5,547,000 | 4,790,000 | ||
Other long-term liabilities | 5,512,000 | 8,020,000 | 5,512,000 | ||
Litigation [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Settlement of claim | 400,000 | ||||
Selling, general and administrative [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Claim accrual recorded in selling, general and other administrative expenses | 1,000,000 | ||||
Reduction in selling, general and administrative expenses | 600,000 | ||||
Embolitech LLC [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Contingent payments upon achievement of regulatory milestones | $ 1,000,000 | ||||
Installment payment beginning period | 2021 | ||||
Installment payment ending period | 2024 | ||||
CRO [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Contractual obligation remaining to be paid | $ 10,000,000 | ||||
CRO [Member] | Minimum [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Gross contractual obligation | 35,000,000 | ||||
CRO [Member] | Maximum [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Gross contractual obligation | 40,000,000 | ||||
CRO [Member] | Maximum [Member] | CRO Pass-through Expenses [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Gross contractual obligation | $ 30,000,000 | ||||
In-Process Research and Development [Member] | Embolitech LLC [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Payments to acquire in-process research and development | 5,000,000 | ||||
Contingency period ending year | 2033 | ||||
Acquisition charge for in-process of research and development | $ 7,900,000 | ||||
Contingent obligation due and payable as a result of achievement of regulatory milestone(s) | $ 1,000,000 | ||||
Other accrued liabilities current | 1,000,000 | 1,100,000 | 1,000,000 | ||
Other long-term liabilities | 2,100,000 | $ 2,200,000 | 2,100,000 | ||
In-Process Research and Development [Member] | Embolitech LLC [Member] | Forecast [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Contractual obligation payable in fiscal 2021 through fiscal 2024 | $ 3,500,000 | ||||
In-Process Research and Development [Member] | InnoCore Technologies BV [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
License agreement commencement year | 2006 | ||||
Annual minimum payments for licenses | $ 200,000 | ||||
Patent expiry date | 2027-05 | ||||
Future minimum payments associated with license | $ 1,700,000 | ||||
In-Process Research and Development [Member] | Medical Device [Member] | |||||
Commitments And Contingencies [Line Items] | |||||
Payments to acquire in-process research and development | 800,000 | ||||
Contingent payments upon achievement of regulatory milestones | 1,300,000 | ||||
Contingency period ending year | 2022 | ||||
Estimated additional payment to acquire intellectual property assets | 200,000 | ||||
Acquisition charge for in-process of research and development | $ 900,000 | $ 900,000 |
Reportable Segment Informatio_2
Reportable Segment Information - Additional Information (Detail) | 12 Months Ended |
Sep. 30, 2020Segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 2 |
Reportable Segment Informatio_3
Reportable Segment Information - Segment Revenue, Operating (Loss) Income and Depreciation and Amortization (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | $ 22,543 | $ 26,883 | $ 22,822 | $ 22,616 | $ 30,816 | $ 24,344 | $ 22,676 | $ 22,241 | $ 94,864 | $ 100,077 | $ 81,336 |
Operating (loss) income | $ (1,993) | $ 1,164 | $ (156) | $ (266) | $ 3,875 | $ 1,017 | $ 865 | $ 712 | (1,251) | 6,469 | (8,799) |
Depreciation and amortization | 7,263 | 7,312 | 6,431 | ||||||||
Operating Segments [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 94,864 | 100,077 | 81,336 | ||||||||
Operating (loss) income | 8,525 | 15,414 | 141 | ||||||||
Operating Segments [Member] | Medical Device [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 71,401 | 78,353 | 60,513 | ||||||||
Operating (loss) income | (3,246) | 4,794 | (8,478) | ||||||||
Depreciation and amortization | 6,223 | 5,811 | 5,376 | ||||||||
Operating Segments [Member] | In Vitro Diagnostics [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 23,463 | 21,724 | 20,823 | ||||||||
Operating (loss) income | 11,771 | 10,620 | 8,619 | ||||||||
Depreciation and amortization | 483 | 464 | 394 | ||||||||
Corporate [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Operating (loss) income | (9,776) | (8,945) | (8,940) | ||||||||
Depreciation and amortization | $ 557 | $ 1,037 | $ 661 |
Reportable Segment Informatio_4
Reportable Segment Information - Revenue from Customers (Detail) - Revenue [Member] - Customer Concentration Risk [Member] | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Medtronic [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of revenue | 14.00% | 14.00% | 16.00% |
Abbott [Member] | |||
Revenue, Major Customer [Line Items] | |||
Percentage of revenue | 19.00% | 19.00% | 11.00% |
Reportable Segment Informatio_5
Reportable Segment Information - Geographic Revenue and Long-lived Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
U.S. [Member] | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Long-lived assets, net | $ 25,273 | $ 24,450 | |
Ireland [Member] | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Long-lived assets, net | $ 18,113 | $ 19,524 | |
Revenue [Member] | Geographic Concentration Risk [Member] | Domestic [Member] | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Percentage of consolidated revenue | 78.00% | 81.00% | 79.00% |
Revenue [Member] | Geographic Concentration Risk [Member] | Foreign [Member] | |||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||
Percentage of consolidated revenue | 22.00% | 19.00% | 21.00% |
Quarterly Financial Data (Una_3
Quarterly Financial Data (Unaudited) - Summary of Unaudited Quarterly Results (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total revenue | $ 22,543 | $ 26,883 | $ 22,822 | $ 22,616 | $ 30,816 | $ 24,344 | $ 22,676 | $ 22,241 | $ 94,864 | $ 100,077 | $ 81,336 |
Operating (loss) income | (1,993) | 1,164 | (156) | (266) | 3,875 | 1,017 | 865 | 712 | (1,251) | 6,469 | (8,799) |
Net income (loss) | $ (2,946) | $ 2,459 | $ 1,462 | $ 148 | $ 3,554 | $ 1,466 | $ 1,262 | $ 1,310 | $ 1,123 | $ 7,592 | $ (4,457) |
Basic net income (loss) per share | $ (0.22) | $ 0.18 | $ 0.11 | $ 0.01 | $ 0.27 | $ 0.11 | $ 0.09 | $ 0.10 | $ 0.08 | $ 0.57 | $ (0.34) |
Diluted net income (loss) per share | $ (0.22) | $ 0.18 | $ 0.11 | $ 0.01 | $ 0.26 | $ 0.11 | $ 0.09 | $ 0.09 | $ 0.08 | $ 0.55 | $ (0.34) |
Quarterly Financial Data (Una_4
Quarterly Financial Data (Unaudited) - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2017 | |
Quarterly Financial Data [Line Items] | ||||||||||||
Revenue recognized from collaborative arrangement on payments received during period | $ 22,543,000 | $ 26,883,000 | $ 22,822,000 | $ 22,616,000 | $ 30,816,000 | $ 24,344,000 | $ 22,676,000 | $ 22,241,000 | $ 94,864,000 | $ 100,077,000 | $ 81,336,000 | |
Other | $ 56,000 | $ 28,000 | $ 54,000 | |||||||||
U.S. federal statutory tax rate | 35.00% | 21.00% | 21.00% | 24.50% | 35.00% | |||||||
Acquisition charge for in-process of research and development | $ 890,000 | $ 7,888,000 | ||||||||||
CARES Act [Member] | ||||||||||||
Quarterly Financial Data [Line Items] | ||||||||||||
Other | $ 1,800,000 | |||||||||||
ViaCyte, Inc. [Member] | ||||||||||||
Quarterly Financial Data [Line Items] | ||||||||||||
Other-than-temporary impairment loss on investment | 500,000 | $ 500,000 | 4,800,000 | |||||||||
Strategic investment | $ 0 | |||||||||||
In-Process Research and Development [Member] | Medical Device [Member] | ||||||||||||
Quarterly Financial Data [Line Items] | ||||||||||||
Acquisition charge for in-process of research and development | 900,000 | 900,000 | ||||||||||
Abbott Agreement [Member] | ||||||||||||
Quarterly Financial Data [Line Items] | ||||||||||||
Revenue recognized from collaborative arrangement on payments received during period | 12,000,000 | 13,500,000 | 4,400,000 | |||||||||
Collaborative arrangement, revenue recognized on payment(s) received during current period | 6,700,000 | 5,100,000 | ||||||||||
Collaborative arrangement payment received | 45,800,000 | |||||||||||
Abbott Agreement [Member] | Milestone Payment [Member] | ||||||||||||
Quarterly Financial Data [Line Items] | ||||||||||||
Collaborative arrangement payment received | $ 10,800,000 | $ 10,000,000 | 10,800,000 | 10,000,000 | ||||||||
Royalties and License Fees [Member] | ||||||||||||
Quarterly Financial Data [Line Items] | ||||||||||||
Revenue recognized from collaborative arrangement on payments received during period | $ 40,634,000 | $ 48,458,000 | $ 35,424,000 | |||||||||
Royalties and License Fees [Member] | One Time License Extension [Member] | ||||||||||||
Quarterly Financial Data [Line Items] | ||||||||||||
Revenue recognized from collaborative arrangement on payments received during period | $ 1,000,000 |
Schedule of Valuation and Qua_2
Schedule of Valuation and Qualifying Accounts - Valuation and Qualifying Accounts (Detail) - Allowance for doubtful accounts [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Period | $ 200 | $ 147 | $ 230 |
Additions: Charges to Income | 73 | 188 | 64 |
Deductions: Other Changes (Debit) Credit | (143) | (135) | (147) |
Balance at End of Period | $ 130 | $ 200 | $ 147 |