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Summary of Significant Accounting Policies and Select Balance Sheet Information (Policies)
12 Months Ended
Sep. 30, 2021
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 credit losses. The allowance for credit losses reflects the current estimate of credit losses expected to be incurred over the life of the accounts receivable. We consider various factors in establishing, monitoring and adjusting the allowance for credit losses including the aging of accounts and aging trends, the historical level of charge-offs, and specific exposures related to particular customers. We base our estimates of credit loss reserves on historical experience and adjust, as necessary, to reflect current conditions using reasonable and supportable forecasts not already reflected in the historical loss information.

Investments

Investments

As of September 30, 2021 and 2020, investments consist of commercial paper and corporate bond securities, are classified as available-for-sale, and are reported at fair value. Interest earned on debt securities, including amortization of premiums and accretion of discounts, is included in investment income, net within other (expense) income. Realized gains and losses from the sales of debt securities, which are included in other (expense) income, are determined using the specific identification method. Investment purchases are accounted for on the date the trade is executed, which may not be the same as the date the transaction is cash settled. Unrealized gains and losses, net of tax, are excluded from the consolidated statements of operations and reported on the consolidated statements of comprehensive income as well as a separate component of stockholders’ equity on the consolidated balance sheets. For investments in an unrealized loss position, we make the following assessments. If it is more likely than not we will sell the investment before recovery of its amortized cost basis, we write down the security’s amortized cost basis to fair value and reclassify the net unrealized loss from accumulated other comprehensive income to other (expense) income. If the decline in fair value is deemed to be due to a credit loss, we recognize an allowance for the expected credit loss to reduce the cost basis to fair value, with a corresponding adjustment to other (expense) income.

The amortized cost, unrealized holding gains and losses, and fair value of available-for-sale securities were as follows:

 

 

September 30, 2021

 

 

 

Valuation

 

 

Balance Sheet Classification

 

(In thousands)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

 

Current Assets

 

 

Noncurrent Assets

 

Commercial paper and

    corporate bonds

 

$

9,718

 

 

$

2

 

 

$

(1

)

 

$

9,719

 

 

$

7,717

 

 

$

2,002

 

Total

 

$

9,718

 

 

$

2

 

 

$

(1

)

 

$

9,719

 

 

$

7,717

 

 

$

2,002

 

 

 

 

September 30, 2020

 

 

 

Valuation

 

 

Balance Sheet Classification

 

(In thousands)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

 

Current Assets

 

 

Noncurrent Assets

 

Commercial paper and

    corporate bonds

 

$

30,313

 

 

$

19

 

 

$

(19

)

 

$

30,313

 

 

$

30,313

 

 

$

 

Total

 

$

30,313

 

 

$

19

 

 

$

(19

)

 

$

30,313

 

 

$

30,313

 

 

$

 

 

There were no held-to-maturity debt securities as of September 30, 2021 and 2020. There were no realized gains or losses on sales of available-for-sale securities for fiscal 2021, 2020 or 2019.

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: 

 

 

September 30,

 

(In thousands)

 

2021

 

 

2020

 

Raw materials

 

$

4,165

 

 

$

3,758

 

Work-in process

 

 

1,295

 

 

 

817

 

Finished products

 

 

1,300

 

 

 

1,391

 

Total

 

$

6,760

 

 

$

5,966

 

Prepaids and Other Current Assets, Current

Prepaids and Other Assets, Current

Prepaids and other current assets consisted of the following:

 

 

September 30,

 

(In thousands)

 

2021

 

 

2020

 

Prepaid expenses

 

$

1,712

 

 

$

1,418

 

Irish research and development credits receivable

 

 

1,164

 

 

 

1,177

 

CARES Act employee retention credit receivable

 

 

3,577

 

 

 

 

Other

 

 

 

 

 

775

 

Prepaids and other

 

$

6,453

 

 

$

3,370

 

In fiscal 2021, a benefit of $3.6 million was recorded to reduce operating costs and expenses as a result of our eligibility for the employee retention credit under the provisions of the Coronavirus Aid, Relief and Economic Security Act (the "CARES Act") enacted in March 2020. This $3.6 million benefit and corresponding receivable reflect anticipated reimbursement of personnel expenses we incurred in fiscal 2021 and 2020.

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 $4.9 million, $4.8 million and $4.7 million in fiscal 2021, 2020 and 2019, respectively.

The September 30, 2021 and 2020 balances in construction-in-progress include the cost of equipment and building improvements not yet placed in service. 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)

 

2021

 

 

2020

 

Land

 

N/A

 

$

4,419

 

 

$

4,419

 

Laboratory fixtures and equipment

 

3 to 10

 

 

29,482

 

 

 

28,600

 

Buildings and improvements

 

3 to 20

 

 

26,573

 

 

 

25,638

 

Leasehold improvements

 

5 to 10

 

 

6,499

 

 

 

4,836

 

Office furniture and equipment

 

3 to 10

 

 

8,713

 

 

 

7,334

 

Construction-in-progress

 

 

 

 

2,120

 

 

 

2,238

 

Less: Accumulated depreciation

 

 

 

 

(47,716

)

 

 

(42,962

)

Property and equipment, net

 

 

 

$

30,090

 

 

$

30,103

 

Intangible Assets

Intangible Assets

Intangible assets consisted of the following:

 

 

September 30, 2021

 

(Dollars in thousands)

 

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

 

8.9

 

 

$

13,216

 

 

$

(8,878

)

 

$

4,338

 

Developed technology

 

 

11.9

 

 

 

36,531

 

 

 

(5,652

)

 

 

30,879

 

Patents and other

 

 

14.1

 

 

 

3,551

 

 

 

(2,294

)

 

 

1,257

 

Total definite-lived intangible assets

 

 

 

 

 

 

53,298

 

 

 

(16,824

)

 

 

36,474

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

 

 

580

 

 

 

 

 

 

580

 

Total intangible assets

 

 

 

 

 

$

53,878

 

 

$

(16,824

)

 

$

37,054

 

 

 

 

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

 

 

$

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

 

 

The Company recorded amortization expense of $3.1 million, $2.5 million and $2.6 million in fiscal 2021, 2020 and 2019, respectively.

Based on the intangible assets in service as of September 30, 2021, estimated amortization expense for future fiscal years is as follows:

(In thousands)

 

 

 

 

2022

 

$

4,668

 

2023

 

 

4,070

 

2024

 

 

3,978

 

2025

 

 

3,940

 

2026

 

 

2,992

 

Thereafter

 

 

16,826

 

Definite-lived intangible assets

 

$

36,474

 

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 1st of each fiscal year. After completing the fiscal 2019 impairment analysis, 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 on the consolidated statements of operations. No impairment charges were recorded in fiscal 2021 and 2020 as there were no indicators of impairment associated with indefinite-lived intangible assets.

Goodwill

Goodwill

Goodwill in the Medical Device reporting unit represents the gross value from the fiscal 2021 acquisition of Vetex Medical Limited (“Vetex”) and the fiscal 2016 acquisitions of Creagh Medical, Ltd. (“Creagh Medical”) and NorMedix, Inc. (“NorMedix”). Goodwill in the In Vitro Diagnostics reporting unit represents the gross value from the acquisition of BioFX Laboratories, Inc. in 2007. Refer to Note 12 Acquisitions for further disclosures for Vetex.

Changes in the carrying amount of goodwill by segment were as follows:

(In thousands)

 

In Vitro Diagnostics

 

 

Medical Device

 

 

Total

 

Goodwill as of September 30, 2019

 

$

8,010

 

 

$

18,161

 

 

$

26,171

 

Foreign currency translation adjustment

 

 

 

 

 

1,014

 

 

 

1,014

 

Goodwill as of September 30, 2020

 

 

8,010

 

 

 

19,175

 

 

 

27,185

 

Acquisition of Vetex Medical Limited

 

 

 

 

 

19,089

 

 

 

19,089

 

Foreign currency translation adjustment

 

 

 

 

 

(668

)

 

 

(668

)

Goodwill as of September 30, 2021

 

$

8,010

 

 

$

37,596

 

 

$

45,606

 

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 reportable 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 1st of each fiscal year. 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 2021 annual impairment test which utilized a quantitative assessment. No goodwill impairment charges were recorded in fiscal 2021, 2020 or 2019 as there were no indicators of impairment associated with either of the reporting units.

Other Assets, Noncurrent

Other Assets, Noncurrent

Other noncurrent assets consisted of the following:

 

 

September 30,

 

(In thousands)

 

2021

 

 

2020

 

Operating lease right-of-use assets

 

$

2,435

 

 

$

2,508

 

Other noncurrent assets

 

 

1,283

 

 

 

1,761

 

Other assets, net

 

$

3,718

 

 

$

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.

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 2021, 2020 and 2019, 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)

 

2021

 

 

2020

 

Accrued professional fees

 

$

489

 

 

$

239

 

Accrued clinical study expense

 

 

1,667

 

 

 

2,206

 

Accrued purchases

 

 

1,195

 

 

 

647

 

Acquisition of in-process research and development and

    intangible assets

 

 

494

 

 

 

1,148

 

Due to customers

 

 

112

 

 

 

321

 

Construction-in-progress

 

 

23

 

 

 

272

 

Operating lease liability, current portion

 

 

518

 

 

 

436

 

Other

 

 

407

 

 

 

278

 

Total accrued other liabilities

 

$

4,905

 

 

$

5,547

 

Other Long-term Liabilities

Other Long-term Liabilities

Other long-term liabilities consisted of the following:

 

 

September 30,

 

(In thousands)

 

2021

 

 

2020

 

Deferred consideration (1)

 

$

5,106

 

 

$

2,216

 

Contingent consideration (2)

 

 

817

 

 

 

 

Unrecognized tax benefits (3)

 

 

2,538

 

 

 

2,464

 

Operating lease liabilities

 

 

3,188

 

 

 

3,340

 

Other long-term liabilities

 

$

11,649

 

 

$

8,020

 

 

(1)

Deferred consideration consists of the present value of guaranteed payments to be made in connection with the fiscal 2021 Vetex acquisition (Note 12) and with in-process R&D technology asset acquisitions in fiscal 2019 and 2018 (Note 11).

 

(2)

Contingent consideration consists of the fair value of contingent consideration liabilities associated with the fiscal 2021 Vetex acquisition (Note 5 and Note 12).

 

(3)

Balance of unrecognized tax benefits (Note 9) includes accrued interest and penalties, if applicable.

Revenue Recognition

Revenue Recognition

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. Revenue is recorded net of taxes collected from customers, and taxes collected are recorded as current liabilities until remitted to the relevant government authority. The amount of foreign taxes imposed on specific revenue producing transactions that is the responsibility of the Company is expensed as incurred and reported in income tax expense on the consolidated statements of operations. 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 Sales

 

Royalties and License Fees

 

Research, Development and Other

IVD segment sales of chemical components: stabilization products, substrates, surface coatings and antigens to the diagnostic and biomedical research markets

 

Medical Device segment royalties from licensing of our proprietary surface modification coating and medical device technologies to medical device manufacturers

 

Medical Device segment commercial development feasibility services and contract coating services

Medical Device segment sales of reagent chemicals to licensees

 

Medical Device segment license fees primarily associated with the Abbott Agreement

 

IVD segment commercial development services

Medical Device segment sales of vascular intervention medical device products to original equipment manufacturer suppliers and distributors

 

 

 

 

The Company recognizes revenue when control is transferred to the customer. The transfer of control varies by revenue classification and is described below. If a contract contains more than one distinct performance obligation, the transaction price is allocated to each performance obligation based on relative standalone selling price.

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 “SurVeil 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 Collaborative Arrangement (the “Abbott Agreement”). Under the Abbott Agreement, the Company has received payments totaling $60.8 million as of September 30, 2021 and may receive an additional contingent milestone payment of up to $30 million, pursuant to the terms of the Abbott Agreement. The performance obligation identified in the Abbott Agreement 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. The customer, Abbott, simultaneously receives and consumes the benefits of the R&D and Clinical Activities as study data are generated to support regulatory approval submissions. Control is effectively transferred over time as we complete the TRANSCEND clinical study of the SurVeil DCB and related regulatory activities. License fee revenue related to this contract is recognized 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. Use of the cost-to-cost method requires significant estimates, including the total cost of the TRANSCEND study, which is expected to be completed over the next four years. Revenue is recorded based on the cost-to-cost completion estimate relative to the transaction price, which is equal to the total upfront fee plus the expected value of the clinical and regulatory milestones.

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 on 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 Arrangement 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. See Note 3 Revenue for further contract asset disclosures.

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. See Note 4 Collaborative Arrangement for further deferred revenue disclosures.

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. See Note 4 Collaborative Arrangement for further performance obligation disclosures.

Leases

Leases

Effective in fiscal 2020 (October 1, 2019), the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases using the optional transition method. Refer to “New Accounting Pronouncements” within this Note 2 for further information on the impact of adoption. The Company leases facilities for research, office, manufacturing and warehousing. The Company determines whether a contract is a lease or contains a lease at inception date. Upon commencement, the Company recognizes a right-of-use asset and lease liability based on the net present value of the future minimum lease payments over the lease term at the commencement date. The net present value of future minimum lease payments recorded upon lease commencement is reduced by the discounted value of any leasehold improvement incentives payable to the Company considered to be in-substance fixed payments. The unamortized balance of leasehold improvement incentives in the form of tenant allowances represents the primary difference between the balance of the right-of-use assets and operating lease liabilities. As the Company’s leases typically do not provide an implicit rate, the Company’s lease liabilities are measured on a discounted basis using the Company's incremental borrowing rate. Lease terms used in the recognition of right-of-use assets and lease liabilities include only options to extend the lease that are reasonably certain to be exercised. The consolidated balance sheets do not include recognized assets or liabilities for leases that, at the commencement date, have a term of twelve months or less and do not include an option to purchase the underlying asset that is reasonably certain to be exercised. The Company recognizes such leases on the consolidated statements of operations on a straight-line basis over the lease term.

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:

 

 

September 30,

 

(In thousands)

 

2021

 

 

2020

 

Right-of-use assets:

 

 

 

 

 

 

 

 

Other assets

 

$

2,435

 

 

$

2,508

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities:

 

 

 

 

 

 

 

 

Other accrued liabilities

 

$

518

 

 

$

436

 

Other long-term liabilities

 

 

3,188

 

 

 

3,340

 

Total operating lease liabilities

 

$

3,706

 

 

$

3,776

 

As of September 30, 2021, operating lease maturities were as follows:

(In thousands)

 

 

 

 

2022

 

$

657

 

2023

 

 

671

 

2024

 

 

685

 

2025

 

 

699

 

2026

 

 

604

 

Thereafter

 

 

892

 

Total expected operating lease payments

 

 

4,208

 

Less: Imputed interest

 

 

(502

)

Total operating lease liabilities

 

$

3,706

 

Operating lease cost was $0.8 million and $0.6 million for fiscal 2021 and 2020, respectively. Rent expense for fiscal 2019 was $0.5 million. Cash paid for operating lease liabilities approximated operating lease cost for fiscal 2021 and 2020. As of September 30, 2021, the weighted average remaining lease term for operating leases was 6.2 years, and the weighted average discount rate used to determine operating lease liabilities was 4.0%.

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.

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” in this Note 2. 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 evaluate 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. In prior fiscal years, the Company has been 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 and $0.7 million in fiscal 2020 and 2019, respectively, as a reduction of R&D expense.

Income Taxes

Income Taxes

We record a tax (provision) benefit 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.

Net Income Per Share Data

Net Income Per Share Data

Basic net income per common share is calculated by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net 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.

The following table presents the denominator for the computation of diluted weighted average shares outstanding:

 

 

Fiscal Year

 

(In thousands)

 

2021

 

 

2020

 

 

2019

 

Basic weighted average shares outstanding

 

 

13,765

 

 

 

13,552

 

 

 

13,389

 

Dilutive effect of outstanding stock options, non-vested

    restricted stock, and non-vested restricted stock units

 

 

224

 

 

 

260

 

 

 

390

 

Diluted weighted average shares outstanding

 

 

13,989

 

 

 

13,812

 

 

 

13,779

 

 

The calculation of weighted average diluted shares outstanding excluded outstanding common stock options associated with the right to purchase less than 0.1 million shares for both fiscal 2021 and 2020 and 0.2 million shares for fiscal 2019, as their inclusion would have had an antidilutive effect on diluted net income per share for those periods.

Business Combinations

Business Combinations

For acquisitions accounted for as business combinations, we record assets and liabilities acquired at their respective fair values as of the acquisition date. Contingent consideration is recognized at fair value as of the acquisition date, and changes in fair value are recognized in earnings until settlement. Acquisition-related transaction costs are expensed as incurred.

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 on the consolidated balance sheets. Realized foreign currency transaction gains and losses are included in other (expense) income on the consolidated statements of operations.

New Accounting Pronouncements

New Accounting Pronouncements

Accounting Standards Recently Adopted

Credit Losses. In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13, Financial Instruments – Credit Losses, Measurement of Credit Losses on Financial Statements. This ASU requires a financial asset (or a group of financial assets) measured at an amortized cost basis to be presented at the net amount expected to be collected. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial asset(s) to present the net carrying value at the amount expected to be collected on the financial asset. Effective in fiscal 2021 (October 1, 2020), we adopted this guidance using the modified retrospective method. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.

Income Taxes. In December 2019, the FASB 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. Effective in fiscal 2021 (October 1, 2020), we adopted this guidance using a prospective approach. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.

Leases. In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASC Topic 842” or the “new lease accounting standard”). The standard maintains two classifications of leases: finance leases, which replace capital leases, and operating leases. Lessees recognize a right-of-use asset and a lease liability on the consolidated balance sheets for those leases previously classified as operating leases under the previous guidance. The liability is equal to the present value of lease payments, while the asset is based on the liability, subject to adjustment, such as for direct costs.

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.

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.

Reportable Segment Information Reportable 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.