Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Dec. 31, 2020 | Feb. 04, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Dec. 31, 2020 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
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 Current Reporting Status | Yes | |
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, $0.05 par value | |
Entity File Number | 0-23837 | |
Entity Incorporation, State or Country Code | MN | |
Entity Tax Identification Number | 41-1356149 | |
Entity Address, Address Line One | 9924 West 74th Street | |
Entity Address, City or Town | Eden Prairie | |
Entity Address, State or Province | MN | |
Entity Address, Postal Zip Code | 55344 | |
City Area Code | 952 | |
Local Phone Number | 500-7000 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 13,755,611 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 35,754 | $ 30,785 |
Available-for-sale securities | 18,120 | 30,313 |
Accounts receivable, net of allowances of $123 and $130 as of December 31, 2020 and September 30, 2020, respectively | 8,065 | 7,675 |
Contract assets — royalties and license fees | 6,566 | 6,108 |
Inventories, net | 6,261 | 5,966 |
Income tax receivable | 2,544 | 2,391 |
Prepaids and other | 3,553 | 3,370 |
Total Current Assets | 80,863 | 86,608 |
Property and equipment, net | 30,346 | 30,103 |
Deferred income taxes | 7,004 | 7,315 |
Intangible assets, net | 12,945 | 13,283 |
Goodwill | 27,864 | 27,185 |
Other assets | 4,534 | 4,269 |
Total Assets | 163,556 | 168,763 |
Current Liabilities: | ||
Accounts payable | 863 | 1,515 |
Accrued liabilities: | ||
Compensation | 2,944 | 6,630 |
Accrued other | 4,086 | 5,547 |
Deferred revenue | 4,553 | 5,200 |
Total Current Liabilities | 12,446 | 18,892 |
Deferred revenue, less current portion | 10,073 | 10,796 |
Other long-term liabilities | 7,630 | 8,020 |
Total Liabilities | 30,149 | 37,708 |
Commitments and Contingencies (Note 17) | ||
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; 13,739 and 13,672 shares issued and outstanding as of December 31, 2020 and September 30, 2020, respectively | 687 | 684 |
Additional paid-in capital | 16,160 | 15,369 |
Accumulated other comprehensive income | 5,006 | 3,174 |
Retained earnings | 111,554 | 111,828 |
Total Stockholders’ Equity | 133,407 | 131,055 |
Total Liabilities and Stockholders’ Equity | $ 163,556 | $ 168,763 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Statement Of Financial Position [Abstract] | ||
Allowances (accounts receivable) | $ 123 | $ 130 |
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 | 13,739,000 | 13,672,000 |
Common stock, shares outstanding | 13,739,000 | 13,672,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | ||
Total revenue | $ 22,297 | $ 22,616 |
Operating costs and expenses: | ||
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember |
Product costs | $ 3,743 | $ 3,203 |
Research and development | 10,882 | 12,142 |
Selling, general and administrative | 7,023 | 6,943 |
Acquired intangible asset amortization | 556 | 594 |
Total operating costs and expenses | 22,204 | 22,882 |
Operating income (loss) | 93 | (266) |
Other (expense) income: | ||
Investment income, net | 41 | 250 |
Interest expense | (60) | (40) |
Foreign exchange loss | (180) | (47) |
Other | 1 | |
Other (expense) income | (199) | 164 |
Loss before income taxes | (106) | (102) |
Income tax (provision) benefit | (168) | 250 |
Net (loss) income | $ (274) | $ 148 |
Basic net (loss) income per share | $ (0.02) | $ 0.01 |
Diluted net (loss) income per share | $ (0.02) | $ 0.01 |
Weighted average number of shares outstanding: | ||
Basic | 13,668 | 13,469 |
Diluted | 13,668 | 13,769 |
Product Sales [Member] | ||
Revenue: | ||
Total revenue | $ 10,102 | $ 9,974 |
Royalties and License Fees [Member] | ||
Revenue: | ||
Total revenue | 9,334 | 10,148 |
Research, Development and Other [Member] | ||
Revenue: | ||
Total revenue | $ 2,861 | $ 2,494 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net (loss) income | $ (274) | $ 148 |
Other comprehensive income: | ||
Net changes related to available-for-sale securities, net of tax | (5) | |
Foreign currency translation adjustments | 1,832 | 1,041 |
Other comprehensive income | 1,832 | 1,036 |
Comprehensive income | $ 1,558 | $ 1,184 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Retained Earnings [Member] |
Beginning balance at Sep. 30, 2019 | $ 122,516 | $ 675 | $ 10,740 | $ 396 | $ 110,705 |
Beginning balance, shares at Sep. 30, 2019 | 13,504 | ||||
Net income (loss) | 148 | 148 | |||
Other comprehensive income, net of tax | 1,036 | 1,036 | |||
Issuance of common stock | $ 7 | (7) | |||
Issuance of common stock, shares | 125 | ||||
Common stock options exercised, net | 91 | 91 | |||
Common stock options exercised, net, shares | 8 | ||||
Purchase of common stock to pay employee taxes | (1,858) | $ (2) | (1,856) | ||
Purchase of common stock to pay employee taxes, shares | (44) | ||||
Stock-based compensation | 1,393 | 1,393 | |||
Ending balance at Dec. 31, 2019 | 123,326 | $ 680 | 10,361 | 1,432 | 110,853 |
Ending balance, shares at Dec. 31, 2019 | 13,593 | ||||
Beginning balance at Sep. 30, 2020 | 131,055 | $ 684 | 15,369 | 3,174 | 111,828 |
Beginning balance, shares at Sep. 30, 2020 | 13,672 | ||||
Net income (loss) | (274) | (274) | |||
Other comprehensive income, net of tax | 1,832 | 1,832 | |||
Issuance of common stock | $ 4 | (4) | |||
Issuance of common stock, shares | 81 | ||||
Common stock options exercised, net | 6 | 6 | |||
Common stock options exercised, net, shares | 3 | ||||
Purchase of common stock to pay employee taxes | (645) | $ (1) | (644) | ||
Purchase of common stock to pay employee taxes, shares | (17) | ||||
Stock-based compensation | 1,433 | 1,433 | |||
Ending balance at Dec. 31, 2020 | $ 133,407 | $ 687 | $ 16,160 | $ 5,006 | $ 111,554 |
Ending balance, shares at Dec. 31, 2020 | 13,739 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Activities: | ||
Net (loss) income | $ (274) | $ 148 |
Adjustments to reconcile net (loss) income to net cash used in operating activities: | ||
Depreciation and amortization | 1,860 | 1,804 |
Stock-based compensation | 1,433 | 1,393 |
Payment of contingent consideration obligations in excess of acquisition-date value | (608) | |
Deferred taxes | 310 | (194) |
Provision for credit losses | (7) | (27) |
Other | 87 | 50 |
Change in operating assets and liabilities: | ||
Accounts receivable and contract asset | (830) | 1,726 |
Inventories | (236) | (413) |
Prepaids and other | (357) | (800) |
Accounts payable | (485) | 529 |
Accrued liabilities | (4,236) | (3,112) |
Income taxes | (165) | (59) |
Deferred revenue | (1,370) | (1,346) |
Net cash used in operating activities | (4,270) | (909) |
Investing Activities: | ||
Purchases of property and equipment | (1,319) | (1,671) |
Payment for acquisition of intangible assets | (1,000) | |
Purchases of available-for-sale securities | (5,820) | (21,758) |
Maturities of available-for-sale securities | 18,013 | 7,425 |
Net cash provided by (used in) investing activities | 9,874 | (16,004) |
Financing Activities: | ||
Issuance of common stock | 6 | 91 |
Payments for taxes related to net share settlement of equity awards | (646) | (1,964) |
Payment of contingent consideration obligations | (2,592) | |
Payments for acquisition of in-process research and development | (150) | |
Net cash used in financing activities | (790) | (4,465) |
Effect of exchange rate changes on cash | 155 | 23 |
Net change in cash and cash equivalents | 4,969 | (21,355) |
Cash and Cash Equivalents: | ||
Beginning of period | 30,785 | 30,361 |
End of period | 35,754 | 9,006 |
Supplemental Information: | ||
Cash paid for income taxes | 9 | 4 |
Noncash investing and financing activities: | ||
Acquisition of property and equipment, net of refundable credits in other current assets and liabilities | 82 | $ 167 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 44 |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 1. Basis of Presentation Overview 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 accompanying unaudited condensed 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. In accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”), the Company has omitted footnote disclosures that would substantially duplicate the disclosures contained in the audited consolidated financial statements of the Company. These unaudited condensed consolidated financial statements should be read together with the audited consolidated financial statements for the fiscal year ended September 30, 2020, and notes thereto included in our Annual Report on Form 10-K as filed with the SEC. 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. The results of operations for the three months ended December 31, 2020 are not necessarily indicative of the results that may be expected for the entire 2021 fiscal year. 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 December 31, 2020 and through the date of this Quarterly Report on Form 10-Q. As of the date of issuance of these unaudited condensed 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 our Annual Report on Form 10-K for the fiscal year ended September 30, 2020. New Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses, Measurement of Credit Losses on Financial Statements In December 2019, the FAS B issued ASU 2019-12, Simplifying the Accounting for Income Taxes , which eliminates certain exceptions related to the approach for intraperiod tax allocation and to the methodology for calculating taxes during the quarters, as well as clarifies the accounting for enacted changes in tax laws . We adopted this guidance using a prospective approach in the first quarter of fiscal 2021. The adoption of this guidance did not have a material impact Company’s condensed consolidated financial statements. No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s condensed consolidated financial statements. |
Revenue
Revenue | 3 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue | 2. Revenue The following table presents the Company’s revenues disaggregated by product classification and by reportable segment. Three Months Ended December 31, (In thousands) 2020 2019 Medical Device Product sales $ 4,561 $ 5,023 Royalties 7,909 8,898 Research, development and other 2,301 2,234 License fees 1,425 1,249 Total Revenue — Medical Device 16,196 17,404 In Vitro Diagnostics Product sales 5,541 4,952 Research, development and other 560 260 Total Revenue — In Vitro Diagnostics 6,101 5,212 Total Revenue $ 22,297 $ 22,616 Contract assets totaled $6.6 million and $6.1 million as of December 31, 2020 and September 30, 2020, respectively. Fluctuations in the balance of contract assets result primarily from changes in sales-based and minimum royalties earned, but not collected at each balance sheet date due to payment timing and contractual changes in the normal course of business. For discussion of contract liability (deferred revenue) balances and remaining performance obligations, see Note 3 Collaborative Arrangements. |
Collaborative Arrangement
Collaborative Arrangement | 3 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborative Arrangement | 3. Collaborative Arrangement On February 26, 2018, the Company entered into an agreement with Abbott Vascular, Inc. (“Abbott”) whereby Abbott has exclusive worldwide commercialization rights for Surmodics' SurVeil TM SurVeil TM SurVeil SurVeil SurVeil As of December 31, 2020, the Company has received payments totaling $45.8 million under the Abbott Agreement, which consist of the following: $25 million upfront fee in fiscal 2018, $10.0 million milestone payment in fiscal 2019, and $10.8 million milestone payment in the third quarter of fiscal 2020. As of December 31, 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 following receipt by Abbott of the clinical study report and related materials from the TRANSCEND pivotal trial demonstrating that the primary safety and primary clinical endpoints are non-inferior to the control device and (ii) $30 million upon premarket approval (“PMA”) of our SurVeil Revenue recognized from the Abbott agreement totaled $1.3 million in both the three months ended December 31, 2020 and 2019. Revenue recognized from the Abbott Agreement, which was included in the respective beginning of fiscal year balances of deferred revenue on the condensed consolidated balance sheets, totaled $1.3 million for both the three months ended December 31, 2020 and 2019. As of December 31, 2020 and September 30, 2020, deferred revenue from the upfront and milestone payments received under the Abbott Agreement of $14.6 million and $15.9 million, respectively, was recorded in the condensed consolidated balance sheets. As of December 31, 2020, the estimated revenue expected to be recognized in future periods related to performance obligations that are unsatisfied for executed contracts with an original duration of one year or more totaled $14.6 million. These remaining performance obligations relate to the Abbott Agreement, exclude potential contingent milestone payments under the Abbott Agreement, and are expected to be recognized over the next five years through fiscal 2025 as services, principally the TRANSCEND clinical trial, are completed. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements 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. Assets and liabilities measured at fair value on a recurring basis by level of the fair value hierarchy were as follows: December 31, 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 $ — $ 24,865 $ — $ 24,865 Available-for-sale securities — 18,120 — 18,120 Total assets $ — $ 42,985 $ — $ 42,985 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 There were no transfers of assets between amounts measured using Level 3 fair value measurements during the three months ended December 31, 2020 and 2019. |
Investments
Investments | 3 Months Ended |
Dec. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | 5. Investments The amortized cost, unrealized holding gains and losses, and fair value of available-for-sale securities were as follows: December 31, 2020 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 18,120 $ 5 $ (5 ) $ 18,120 Total $ 18,120 $ 5 $ (5 ) $ 18,120 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 |
Inventories
Inventories | 3 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | 6. Inventories Inventories consisted of the following components: December 31, September 30, (In thousands) 2020 2020 Raw materials $ 4,147 $ 3,758 Work-in process 939 817 Finished products 1,175 1,391 Total $ 6,261 $ 5,966 |
Other Assets
Other Assets | 3 Months Ended |
Dec. 31, 2020 | |
Investments All Other Investments [Abstract] | |
Other Assets | 7. Other Assets Other assets consisted of the following: December 31, September 30, (In thousands) 2020 2020 Operating lease right-of-use assets 2,478 2,508 Other noncurrent assets 2,056 1,761 Other assets $ 4,534 $ 4,269 Other noncurrent assets include prepaid expenses related to our ongoing clinical trials and a receivable related to refundable Irish research and development tax credits. |
Intangible Assets
Intangible Assets | 3 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | 8. Intangible Assets Intangible assets consisted of the following: December 31, 2020 (In thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 13,917 $ (8,252 ) $ 5,665 Developed technology 11.5 9,816 (4,512 ) 5,304 Patents and other 14.1 3,551 (2,155 ) 1,396 Total definite-lived intangible assets 27,284 (14,919 ) 12,365 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 27,864 $ (14,919 ) $ 12,945 September 30, 2020 (In thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 13,356 $ (7,594 ) $ 5,762 Developed technology 11.5 9,685 (4,200 ) 5,485 Patents and other 14.1 3,551 (2,095 ) 1,456 Total definite-lived intangible assets 26,592 (13,889 ) 12,703 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 27,172 $ (13,889 ) $ 13,283 Intangible asset amortization expense was $0.6 million and $0.7 million for the three months ended December 31, 2020 and 2019, respectively. Based on the intangible assets in service as of December 31, 2020, estimated amortization expense for the remainder of fiscal 2021 and each of the next five fiscal years is as follows: (In thousands) Remainder of 2021 $ 1,914 2022 2,527 2023 1,896 2024 1,799 2025 1,759 2026 726 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 translation rates, or other factors. |
Goodwill
Goodwill | 3 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill | 9. Goodwill Changes in the carrying amount of goodwill by segment were as follows: (In thousands) In Vitro Diagnostics Medical Device Total Balance as of September 30, 2020 $ 8,010 $ 19,175 $ 27,185 Currency translation adjustment — 679 679 Balance as of December 31, 2020 $ 8,010 $ 19,854 $ 27,864 |
Accrued Other Liabilities
Accrued Other Liabilities | 3 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Other Liabilities | 10. Accrued Other Liabilities Accrued other liabilities consisted of the following: December 31, September 30, (In thousands) 2020 2020 Accrued professional fees $ 304 $ 239 Accrued clinical study expense 1,603 2,206 Accrued purchases 925 647 Acquisition of in-process research and development and intangible assets 476 1,148 Due to customers 75 321 Construction-in-progress — 272 Operating lease liability, current portion 456 436 Other 247 278 Total accrued other liabilities $ 4,086 $ 5,547 |
Debt
Debt | 3 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | 11. 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 as of December 31, 2020 and 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. For the three months ended December 31, 2020, unused commitment fees, reported within interest expense on the condensed consolidated statements of operations, totaled less than $0.1 million. 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. |
Stock-based Compensation Plans
Stock-based Compensation Plans | 3 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation Plans | 12. Stock-based Compensation Plans The Company has stock-based compensation plans approved by our shareholders under which it grants stock options, restricted stock awards, restricted stock units and deferred stock units to officers, directors and key employees. Stock-based compensation expense was reported as follows in the condensed consolidated statements of operations: Three Months Ended December 31, (In thousands) 2020 2019 Product costs $ 37 $ 33 Research and development 284 262 Selling, general and administrative 1,112 1,098 Total $ 1,433 $ 1,393 As of December 31, 2020, approximately $10.8 million of total unrecognized compensation costs related to non-vested awards is expected to be recognized over a weighted average period of approximately 2.7 years. Stock Option Awards During the three months ended December 31, 2020 and 2019, the Company awarded 217,000 and 212,000 options to officers and key employees with a weighted average grant date fair value per option of $13.42 and $14.38, respectively. Restricted Stock Awards During the three months ended December 31, 2020 and 2019, the Company awarded 65,000 and 55,000 restricted stock shares, respectively, to certain key employees and officers with a weighted average grant date fair value per share of $37.44 and $42.10, respectively. Restricted Stock Unit Awards During the three months ended December 31, 2020 and 2019, the Company awarded 6,000 and 8,000 restricted stock units, respectively, to key employees in foreign jurisdictions with a weighted average grant date fair value per unit of $37.44 and $42.00, respectively. Employee Stock Purchase Plan Our U.S. employees are eligible to participate in the amended 1999 Employee Stock Purchase Plan (“ESPP”) approved by our shareholders. During the three months ended December 31, 2020 and 2019, no shares were issued under the ESPP. |
Net (Loss) Income Per Share Dat
Net (Loss) Income Per Share Data | 3 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net (Loss) Income Per Share Data | 13. Net (Loss) Income Per Share Data Basic net (loss) income per common share is calculated by dividing net (loss) income by the weighted average number of common shares outstanding during the period. Diluted net income per common share is computed by dividing net (loss) 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 the three months ended December 31, 2020 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 the three months ended December 31, 2020. The following table sets forth the calculation of diluted weighted average shares outstanding: Three Months Ended December 31, (In thousands) 2020 2019 Basic weighted average shares outstanding 13,668 13,469 Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units — 300 Diluted weighted average shares outstanding 13,668 13,769 The calculation of weighted average diluted shares outstanding excludes outstanding stock options associated with the right to purchase 0.1 million shares of common stock for the three months ended December 31, 2019, as their inclusion would have had an antidilutive effect on diluted net income per share for the period. |
Income Taxes
Income Taxes | 3 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes For interim income tax reporting, the Company estimates its annual effective tax rate and applies it to fiscal year-to-date pretax (loss) income, excluding unusual or infrequently occurring discrete items. Tax jurisdictions with losses for which tax benefits cannot be realized are excluded. The Company recorded income tax expense of ($0.2) million and income tax benefit of $0.3 million for the three months ended December 31, 2020 and 2019, respectively. The effective income tax rate for the three months ended December 31, 2020 and 2019 differs from the U.S. federal statutory tax rate of 21% primarily due to the favorable impacts of the U.S. federal research and development tax credits in both periods, stock award activity in both periods, and operating results of our Irish subsidiary, where tax benefit is offset by a valuation allowance. The Company recognized discrete tax benefits related to stock-based compensation awards vested, expired, cancelled and exercised of less than $0.1 million and $0.2 million in the three months ended December 31, 2020 and 2019, respectively. The total amount of unrecognized tax benefits, excluding interest and penalties that, if recognized, would affect the effective tax rate was $3.1 million and $2.7 million as of December 31, 2020 and September 30, 2020, respectively. Interest and penalties related to unrecognized tax benefits are recorded in the income tax (provision) benefit. 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. 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 their respective acquisition dates, pursuant to the terms of the related share purchase agreements. There were no undistributed earnings in foreign subsidiaries as of December 31, 2020 and September 30, 2020. |
Segment Information
Segment Information | 3 Months Ended |
Dec. 31, 2020 | |
Segment Reporting [Abstract] | |
Segment Information | 15. 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, as well as 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 (“IVD”): Design, development and manufacture of component products and technologies for diagnostic immunoassay, as well as molecular tests and biomedical research applications, with products that include protein stabilization reagents, substrates, surface coatings and antigens. Segment revenue, operating income (loss), and depreciation and amortization were as follows: Three Months Ended December 31, (In thousands) 2020 2019 Revenue: Medical Device $ 16,196 $ 17,404 In Vitro Diagnostics 6,101 5,212 Total revenue $ 22,297 $ 22,616 Operating income (loss): Medical Device $ (593 ) $ (423 ) In Vitro Diagnostics 3,220 2,599 Total segment operating income 2,627 2,176 Corporate (2,534 ) (2,442 ) Total operating income (loss) $ 93 $ (266 ) Depreciation and amortization: Medical Device $ 1,652 $ 1,455 In Vitro Diagnostics 105 110 Corporate 103 239 Total depreciation and amortization $ 1,860 $ 1,804 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. |
Leases
Leases | 3 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | 16. Leases Operating lease right-of-use assets and lease liabilities were as follows: December 31, September 30, (In thousands) 2020 2020 Right-of-use assets: Other assets $ 2,478 $ 2,508 Operating lease liabilities: Other accrued liabilities $ 456 $ 436 Other long-term liabilities 3,411 3,340 Total operating lease liabilities $ 3,867 $ 3,776 As of December 31, 2020, operating lease maturities for the remainder of fiscal 2021 and each of the next five fiscal years were as follows: (In thousands) Remainder of 2021 $ 451 2022 612 2023 625 2024 638 2025 651 2026 595 Thereafter 894 Total expected operating lease payments 4,466 Less: Imputed interest (599 ) Total operating lease liabilities $ 3,867 Operating lease cost was $0.2 million and $0.1 million for the three months ended December 31, 2020 and 2019, respectively. Cash paid for operating lease liabilities approximated operating lease cost for three months ended December 31, 2020 and 2019. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 17. Commitments and Contingencies InnoCore Technologies BV . In 2006, the Company entered into a license agreement whereby the Company 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 US dollar exchange rate as of December 31, 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 $1.5 million as of December 31, 2020. The license is currently utilized by one of the Company’s drug delivery customers. Clinical Trials. The Company has engaged clinical trial clinical research organization (“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 approximately $30 million in the aggregate. As of December 31, 2020, an estimated $9 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 the fiscal 2019, the Company acquired certain intellectual property assets supporting ongoing development of the Company’s medical device pipeline and paid the sellers $0.8 million in fiscal 2019 and $0.2 million in the first quarter of fiscal 2021. An additional $1.1 million in payments is contingent upon achievement of certain strategic milestones within a contingency period ending in 2022. 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, $1.0 million in the second quarter of fiscal 2020, and $1.0 million in the first quarter of fiscal 2021. The Company is obligated to pay additional installments totaling $2.5 million in fiscal 2022 through fiscal 2024. 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 certain regulatory milestones within a contingency period ending in 2033. As of December 31, 2020, $0.5 million and $1.8 million related to these asset acquisitions was recorded in other accrued liabilities and other long-term liabilities, respectively, on the condensed consolidated balance sheets. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
New Accounting Pronouncements | New Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses, Measurement of Credit Losses on Financial Statements In December 2019, the FAS B issued ASU 2019-12, Simplifying the Accounting for Income Taxes , which eliminates certain exceptions related to the approach for intraperiod tax allocation and to the methodology for calculating taxes during the quarters, as well as clarifies the accounting for enacted changes in tax laws . We adopted this guidance using a prospective approach in the first quarter of fiscal 2021. The adoption of this guidance did not have a material impact Company’s condensed consolidated financial statements. No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s condensed consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Dec. 31, 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. Three Months Ended December 31, (In thousands) 2020 2019 Medical Device Product sales $ 4,561 $ 5,023 Royalties 7,909 8,898 Research, development and other 2,301 2,234 License fees 1,425 1,249 Total Revenue — Medical Device 16,196 17,404 In Vitro Diagnostics Product sales 5,541 4,952 Research, development and other 560 260 Total Revenue — In Vitro Diagnostics 6,101 5,212 Total Revenue $ 22,297 $ 22,616 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Dec. 31, 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: December 31, 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 $ — $ 24,865 $ — $ 24,865 Available-for-sale securities — 18,120 — 18,120 Total assets $ — $ 42,985 $ — $ 42,985 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 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Amortized Cost, Unrealized Holding Gains and (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: December 31, 2020 (In thousands) Amortized Cost Unrealized Gains Unrealized Losses Fair Value Commercial paper and corporate bonds $ 18,120 $ 5 $ (5 ) $ 18,120 Total $ 18,120 $ 5 $ (5 ) $ 18,120 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 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Components of Inventories | Inventories consisted of the following components: December 31, September 30, (In thousands) 2020 2020 Raw materials $ 4,147 $ 3,758 Work-in process 939 817 Finished products 1,175 1,391 Total $ 6,261 $ 5,966 |
Other Assets (Tables)
Other Assets (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Investments All Other Investments [Abstract] | |
Summary of Other Assets | Other assets consisted of the following: December 31, September 30, (In thousands) 2020 2020 Operating lease right-of-use assets 2,478 2,508 Other noncurrent assets 2,056 1,761 Other assets $ 4,534 $ 4,269 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following: December 31, 2020 (In thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 13,917 $ (8,252 ) $ 5,665 Developed technology 11.5 9,816 (4,512 ) 5,304 Patents and other 14.1 3,551 (2,155 ) 1,396 Total definite-lived intangible assets 27,284 (14,919 ) 12,365 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 27,864 $ (14,919 ) $ 12,945 September 30, 2020 (In thousands) Weighted Average Original Life (Years) Gross Carrying Amount Accumulated Amortization Net Definite-lived intangible assets: Customer lists and relationships 8.9 $ 13,356 $ (7,594 ) $ 5,762 Developed technology 11.5 9,685 (4,200 ) 5,485 Patents and other 14.1 3,551 (2,095 ) 1,456 Total definite-lived intangible assets 26,592 (13,889 ) 12,703 Unamortized intangible assets: Trademarks and trade names 580 — 580 Total intangible assets $ 27,172 $ (13,889 ) $ 13,283 |
Estimated Amortization Expense | Based on the intangible assets in service as of December 31, 2020, estimated amortization expense for the remainder of fiscal 2021 and each of the next five fiscal years is as follows: (In thousands) Remainder of 2021 $ 1,914 2022 2,527 2023 1,896 2024 1,799 2025 1,759 2026 726 |
Goodwill (Tables)
Goodwill (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Carrying Amount of Goodwill By Segment | Changes in the carrying amount of goodwill by segment were as follows: (In thousands) In Vitro Diagnostics Medical Device Total Balance as of September 30, 2020 $ 8,010 $ 19,175 $ 27,185 Currency translation adjustment — 679 679 Balance as of December 31, 2020 $ 8,010 $ 19,854 $ 27,864 |
Accrued Other Liabilities (Tabl
Accrued Other Liabilities (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Other Liabilities | Accrued other liabilities consisted of the following: December 31, September 30, (In thousands) 2020 2020 Accrued professional fees $ 304 $ 239 Accrued clinical study expense 1,603 2,206 Accrued purchases 925 647 Acquisition of in-process research and development and intangible assets 476 1,148 Due to customers 75 321 Construction-in-progress — 272 Operating lease liability, current portion 456 436 Other 247 278 Total accrued other liabilities $ 4,086 $ 5,547 |
Stock-based Compensation Plans
Stock-based Compensation Plans (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation Expenses | Stock-based compensation expense was reported as follows in the condensed consolidated statements of operations: Three Months Ended December 31, (In thousands) 2020 2019 Product costs $ 37 $ 33 Research and development 284 262 Selling, general and administrative 1,112 1,098 Total $ 1,433 $ 1,393 |
Net (Loss) Income Per Share D_2
Net (Loss) Income Per Share Data (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Calculation of Diluted Weighted Average Shares Outstanding | The following table sets forth the calculation of diluted weighted average shares outstanding: Three Months Ended December 31, (In thousands) 2020 2019 Basic weighted average shares outstanding 13,668 13,469 Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units — 300 Diluted weighted average shares outstanding 13,668 13,769 |
Segment Information (Tables)
Segment Information (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Segment Reporting [Abstract] | |
Segment Revenue, Operating Income (Loss) and Depreciation and Amortization | Segment revenue, operating income (loss), and depreciation and amortization were as follows: Three Months Ended December 31, (In thousands) 2020 2019 Revenue: Medical Device $ 16,196 $ 17,404 In Vitro Diagnostics 6,101 5,212 Total revenue $ 22,297 $ 22,616 Operating income (loss): Medical Device $ (593 ) $ (423 ) In Vitro Diagnostics 3,220 2,599 Total segment operating income 2,627 2,176 Corporate (2,534 ) (2,442 ) Total operating income (loss) $ 93 $ (266 ) Depreciation and amortization: Medical Device $ 1,652 $ 1,455 In Vitro Diagnostics 105 110 Corporate 103 239 Total depreciation and amortization $ 1,860 $ 1,804 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
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: December 31, September 30, (In thousands) 2020 2020 Right-of-use assets: Other assets $ 2,478 $ 2,508 Operating lease liabilities: Other accrued liabilities $ 456 $ 436 Other long-term liabilities 3,411 3,340 Total operating lease liabilities $ 3,867 $ 3,776 |
Schedule of Operating Lease Maturities | As of December 31, 2020, operating lease maturities for the remainder of fiscal 2021 and each of the next five fiscal years were as follows: (In thousands) Remainder of 2021 $ 451 2022 612 2023 625 2024 638 2025 651 2026 595 Thereafter 894 Total expected operating lease payments 4,466 Less: Imputed interest (599 ) Total operating lease liabilities $ 3,867 |
Revenue - Summary of Revenues D
Revenue - Summary of Revenues Disaggregated by Product Classification and Reportable Segment (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 22,297 | $ 22,616 |
Product Sales [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 10,102 | 9,974 |
Royalties [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 9,334 | 10,148 |
Research, Development and Other [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 2,861 | 2,494 |
Operating Segments [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 22,297 | 22,616 |
Operating Segments [Member] | Medical Device [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 16,196 | 17,404 |
Operating Segments [Member] | Medical Device [Member] | Product Sales [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 4,561 | 5,023 |
Operating Segments [Member] | Medical Device [Member] | Royalties [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 7,909 | 8,898 |
Operating Segments [Member] | Medical Device [Member] | Research, Development and Other [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 2,301 | 2,234 |
Operating Segments [Member] | Medical Device [Member] | License Fees [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 1,425 | 1,249 |
Operating Segments [Member] | In Vitro Diagnostics [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 6,101 | 5,212 |
Operating Segments [Member] | In Vitro Diagnostics [Member] | Product Sales [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 5,541 | 4,952 |
Operating Segments [Member] | In Vitro Diagnostics [Member] | Research, Development and Other [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 560 | $ 260 |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Revenue From Contract With Customer [Abstract] | ||
Contract assets — royalties and license fees | $ 6,566 | $ 6,108 |
Collaborative Arrangement - Add
Collaborative Arrangement - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||
Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2020 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | $ 22,297,000 | $ 22,616,000 | ||||
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 | |||||
Total revenue | 1,300,000 | 1,300,000 | ||||
Collaboration revenue recognized included in balance at beginning of period | 1,300,000 | $ 1,300,000 | ||||
Upfront and milestone fee payment included in deferred revenue | 14,600,000 | $ 15,900,000 | ||||
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 | ||||
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 | |||||
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 |
Collaborative Arrangement - A_2
Collaborative Arrangement - Additional Information (Detail 1) - Abbott Agreement [Member] - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2021-01-01 $ in Millions | Dec. 31, 2020USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Remaining performance obligation, amount | $ 14.6 |
Remaining performance obligation, satisfaction period | 5 years |
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 | Dec. 31, 2020 | Sep. 30, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | $ 42,985 | $ 48,947 |
Available-for-sale securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | 18,120 | 30,313 |
Cash equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | 24,865 | 18,634 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | 42,985 | 48,947 |
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 | 18,120 | 30,313 |
Significant Other Observable Inputs (Level 2) [Member] | Cash equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Assets measured at fair value | $ 24,865 | $ 18,634 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | ||
Transfers in or out Level 3, Assets | $ 0 | $ 0 |
Investments - Amortized Cost, U
Investments - Amortized Cost, Unrealized Holding Gains and (Losses) and Fair Value of Available-for-sale Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 18,120 | $ 30,313 |
Unrealized Gains | 5 | 19 |
Unrealized Losses | (5) | (19) |
Fair Value | 18,120 | 30,313 |
Commercial paper and corporate bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 18,120 | 30,313 |
Unrealized Gains | 5 | 19 |
Unrealized Losses | (5) | (19) |
Fair Value | $ 18,120 | $ 30,313 |
Inventories - Components of Inv
Inventories - Components of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,147 | $ 3,758 |
Work-in process | 939 | 817 |
Finished products | 1,175 | 1,391 |
Total | $ 6,261 | $ 5,966 |
Other Assets - Summary of Other
Other Assets - Summary of Other Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Schedule of Investments [Line Items] | ||
Other assets | $ 4,534 | $ 4,269 |
Operating Lease Right-of-Use Assets [Member] | ||
Schedule of Investments [Line Items] | ||
Other assets | 2,478 | 2,508 |
Other Noncurrent Assets [Member] | ||
Schedule of Investments [Line Items] | ||
Other assets | $ 2,056 | $ 1,761 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Dec. 31, 2020 | Sep. 30, 2020 | |
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Accumulated Amortization | $ (14,919) | $ (13,889) |
Intangible assets, Gross Carrying Amount | 27,864 | 27,172 |
Intangible assets, Net | $ 12,945 | $ 13,283 |
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 | $ 13,917 | $ 13,356 |
Definite-lived intangible assets, Accumulated Amortization | (8,252) | (7,594) |
Definite-lived intangible assets, Net | $ 5,665 | $ 5,762 |
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 | $ 9,816 | $ 9,685 |
Definite-lived intangible assets, Accumulated Amortization | (4,512) | (4,200) |
Definite-lived intangible assets, Net | $ 5,304 | $ 5,485 |
Patents and Other [Member] | ||
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Weighted Average Original Life (Years) | 14 years 1 month 6 days | 14 years 1 month 6 days |
Definite-lived intangible assets, Gross Carrying Amount | $ 3,551 | $ 3,551 |
Definite-lived intangible assets, Accumulated Amortization | (2,155) | (2,095) |
Definite-lived intangible assets, Net | 1,396 | 1,456 |
Definite-Lived Intangible Assets [Member] | ||
Intangible Assets [Line Items] | ||
Definite-lived intangible assets, Gross Carrying Amount | 27,284 | 26,592 |
Definite-lived intangible assets, Accumulated Amortization | (14,919) | (13,889) |
Definite-lived intangible assets, Net | 12,365 | 12,703 |
Trademarks and Trade Names [Member] | ||
Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets, Net | $ 580 | $ 580 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Amortization expense | $ 0.6 | $ 0.7 |
Intangible Assets - Estimated A
Intangible Assets - Estimated Amortization Expense (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Remainder of 2021 | $ 1,914 |
2022 | 2,527 |
2023 | 1,896 |
2024 | 1,799 |
2025 | 1,759 |
2026 | $ 726 |
Goodwill - Schedule of Carrying
Goodwill - Schedule of Carrying Amount of Goodwill by Segment (Detail) $ in Thousands | 3 Months Ended |
Dec. 31, 2020USD ($) | |
Goodwill [Line Items] | |
Balance as of September 30, 2020 | $ 27,185 |
Currency translation adjustment | 679 |
Balance as of December 31, 2020 | 27,864 |
In Vitro Diagnostics [Member] | |
Goodwill [Line Items] | |
Balance as of September 30, 2020 | 8,010 |
Balance as of December 31, 2020 | 8,010 |
Medical Device [Member] | |
Goodwill [Line Items] | |
Balance as of September 30, 2020 | 19,175 |
Currency translation adjustment | 679 |
Balance as of December 31, 2020 | $ 19,854 |
Accrued Other Liabilities - Sch
Accrued Other Liabilities - Schedule of Accrued Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Accrued Liabilities Current [Abstract] | ||
Accrued professional fees | $ 304 | $ 239 |
Accrued clinical study expense | 1,603 | 2,206 |
Accrued purchases | 925 | 647 |
Acquisition of in-process research and development and intangible assets | 476 | 1,148 |
Due to customers | 75 | 321 |
Construction-in-progress | 272 | |
Operating lease liability, current portion | 456 | 436 |
Other | 247 | 278 |
Total accrued other liabilities | $ 4,086 | $ 5,547 |
Debt - Additional Information (
Debt - Additional Information (Details) - Secured Revolving Credit Facility [Member] - Loan and Security Agreement [Member] - USD ($) | 3 Months Ended | ||
Dec. 31, 2020 | Sep. 30, 2020 | Sep. 14, 2020 | |
Line Of Credit Facility [Line Items] | |||
Revolving credit facility, maximum borrowing capacity | $ 25,000,000 | ||
Revolving credit facility, outstanding balance | $ 0 | $ 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 | ||
Interest Expense [Member] | |||
Line Of Credit Facility [Line Items] | |||
Revolving credit facility, unused commitment fee | $ 100,000 | ||
Minimum [Member] | |||
Line Of Credit Facility [Line Items] | |||
Revolving credit facility, interest rate | 3.25 |
Stock-based Compensation Plan_2
Stock-based Compensation Plans - Stock-based Compensation Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 1,433 | $ 1,393 |
Product costs [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 37 | 33 |
Research and development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 284 | 262 |
Selling, general and administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 1,112 | $ 1,098 |
Stock-based Compensation Plan_3
Stock-based Compensation Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-Based Compensation Activity [Line Items] | ||
Unrecognized compensation costs, nonvested awards, amount | $ 10.8 | |
Unrecognized compensation costs, nonvested awards, weighted average recognition period | 2 years 8 months 12 days | |
Stock Option Awards [Member] | ||
Stock-Based Compensation Activity [Line Items] | ||
Units granted | 217,000 | 212,000 |
Weighted average grant date fair value per unit | $ 13.42 | $ 14.38 |
Restricted Stock Awards [Member] | ||
Stock-Based Compensation Activity [Line Items] | ||
Units granted | 65,000 | 55,000 |
Weighted average grant date fair value | $ 37.44 | $ 42.10 |
Restricted Stock Unit Awards [Member] | ||
Stock-Based Compensation Activity [Line Items] | ||
Units granted | 6,000 | 8,000 |
Weighted average grant date fair value | $ 37.44 | $ 42 |
Employee Stock Purchase Plan [Member] | ||
Stock-Based Compensation Activity [Line Items] | ||
Shares issued | 0 | 0 |
Net (Loss) Income Per Share D_3
Net (Loss) Income Per Share Data - Calculation of Diluted Weighted Average Shares Outstanding (Detail) - shares shares in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | ||
Basic weighted average shares outstanding | 13,668 | 13,469 |
Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units | 300 | |
Diluted weighted average shares outstanding | 13,668 | 13,769 |
Net (Loss) Income Per Share D_4
Net (Loss) Income Per Share Data - Additional Information (Detail) shares in Millions | 3 Months Ended |
Dec. 31, 2019shares | |
Earnings Per Share [Abstract] | |
Anti-dilutive outstanding stock options | 0.1 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |||
Income tax (expense) benefit | $ (168,000) | $ 250,000 | |
U.S. federal statutory tax rate | 21.00% | 21.00% | |
Discrete tax benefits related to stock-based compensation awards | $ 100,000 | $ 200,000 | |
Unrecognized tax benefits excluding interest and penalties that would impact effective tax rate | 3,100,000 | $ 2,700,000 | |
Undistributed earnings in foreign subsidiaries | $ 0 | $ 0 |
Segment Information - Additiona
Segment Information - Additional Information (Detail) | 3 Months Ended |
Dec. 31, 2020Segment | |
Segment Reporting [Abstract] | |
Number of reportable segments | 2 |
Segment Information - Segment R
Segment Information - Segment Revenue, Operating Income (Loss) and Depreciation and Amortization (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Segment Reporting Information [Line Items] | ||
Revenue | $ 22,297 | $ 22,616 |
Operating income (loss) | 93 | (266) |
Depreciation and amortization | 1,860 | 1,804 |
Operating Segments [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenue | 22,297 | 22,616 |
Operating income (loss) | 2,627 | 2,176 |
Operating Segments [Member] | Medical Device [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenue | 16,196 | 17,404 |
Operating income (loss) | (593) | (423) |
Depreciation and amortization | 1,652 | 1,455 |
Operating Segments [Member] | In Vitro Diagnostics [Member] | ||
Segment Reporting Information [Line Items] | ||
Revenue | 6,101 | 5,212 |
Operating income (loss) | 3,220 | 2,599 |
Depreciation and amortization | 105 | 110 |
Corporate [Member] | ||
Segment Reporting Information [Line Items] | ||
Operating income (loss) | (2,534) | (2,442) |
Depreciation and amortization | $ 103 | $ 239 |
Leases - Balance Sheet Classifi
Leases - Balance Sheet Classification and Amounts of Right-of-Use Assets and Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Right-of-use assets: | ||
Other assets | $ 2,478 | $ 2,508 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | us-gaap:OtherAssetsNoncurrent |
Operating lease liabilities: | ||
Other accrued liabilities | $ 456 | $ 436 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherAccruedLiabilitiesCurrent | us-gaap:OtherAccruedLiabilitiesCurrent |
Other long-term liabilities | $ 3,411 | $ 3,340 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | us-gaap:OtherLiabilitiesNoncurrent |
Total operating lease liabilities | $ 3,867 | $ 3,776 |
Leases - Schedule of Operating
Leases - Schedule of Operating Lease Maturities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Sep. 30, 2020 |
Operating Lease Liabilities Payments Due [Abstract] | ||
Remainder of 2021 | $ 451 | |
2022 | 612 | |
2023 | 625 | |
2024 | 638 | |
2025 | 651 | |
2026 | 595 | |
Thereafter | 894 | |
Total expected operating lease payments | 4,466 | |
Less: Imputed interest | (599) | |
Total operating lease liabilities | $ 3,867 | $ 3,776 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Operating lease cost | $ 0.2 | $ 0.1 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | 36 Months Ended | |||
Dec. 31, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2024 | Sep. 30, 2020 | |
Commitments And Contingencies [Line Items] | ||||||
Payments to acquire intangible assets | $ 1,000,000 | |||||
Other accrued liabilities current | 4,086,000 | $ 5,547,000 | ||||
Other long-term liabilities | 7,630,000 | 8,020,000 | ||||
Embolitech LLC [Member] | ||||||
Commitments And Contingencies [Line Items] | ||||||
Payments to acquire in-process research and development | $ 1,000,000 | $ 5,000,000 | ||||
Contingent payments upon achievement of regulatory milestones | $ 1,000,000 | |||||
Installment payment beginning period | 2022 | |||||
Installment payment ending period | 2024 | |||||
CRO [Member] | ||||||
Commitments And Contingencies [Line Items] | ||||||
Contractual obligation remaining to be paid | $ 9,000,000 | |||||
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 | |||||
Intellectual Property Assets [Member] | ||||||
Commitments And Contingencies [Line Items] | ||||||
Other accrued liabilities current | 500,000 | 1,100,000 | ||||
Other long-term liabilities | $ 1,800,000 | $ 2,200,000 | ||||
Intellectual Property Assets [Member] | Embolitech LLC [Member] | ||||||
Commitments And Contingencies [Line Items] | ||||||
Contingency period ending year | 2033 | |||||
Payments to acquire intangible assets | $ 1,000,000 | |||||
Intellectual Property Assets [Member] | Embolitech LLC [Member] | Forecast [Member] | ||||||
Commitments And Contingencies [Line Items] | ||||||
Contractual obligation payable in fiscal 2022 through fiscal 2024 | $ 2,500,000 | |||||
Intellectual Property Assets [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 | $ 1,500,000 | |||||
Intellectual Property Assets [Member] | Medical Device [Member] | ||||||
Commitments And Contingencies [Line Items] | ||||||
Payments to acquire in-process research and development | 200,000 | $ 800,000 | ||||
Contingent payments upon achievement of regulatory milestones | $ 1,100,000 | |||||
Contingency period ending year | 2022 |