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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended December 31, 2024

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number: 0-23837

 

Surmodics, Inc.

(Exact name of registrant as specified in its charter)

 

Minnesota

41-1356149

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

9924 West 74th Street, Eden Prairie, Minnesota 55344

(Address of principal executive offices) (Zip Code)

 

(952) 500-7000

(Registrant’s telephone number, including area code)

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol

 

Name of each exchange on which registered

Common Stock, $0.05 par value

 

SRDX

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

Non-accelerated filer

Smaller reporting company

 

Emerging Growth Company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

The number of shares of the registrant’s Common Stock, $0.05 par value per share, as of January 27, 2025 was 14,295,998

 

 


 

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements

3

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

30

 

PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

31

Item 3.

Defaults Upon Senior Securities

32

Item 4.

Mine Safety Disclosures

32

Item 5.

Other Information

32

Item 6.

Exhibits

33

SIGNATURES

 

34

 

2


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

 

December 31,

 

 

September 30,

 

 

2024

 

 

2024

 

(In thousands, except per share data)

(Unaudited)

 

ASSETS

 

 

 

 

 

Current Assets:

 

 

 

 

 

Cash and cash equivalents

$

30,145

 

 

$

36,115

 

Available-for-sale securities

 

 

 

 

3,997

 

Accounts receivable, net of allowances of $220 and $144 as of
December 31, 2024 and September 30, 2024, respectively

 

12,559

 

 

 

13,292

 

Contract assets

 

9,879

 

 

 

9,872

 

Inventories

 

15,261

 

 

 

15,168

 

Prepaids and other

 

4,005

 

 

 

2,860

 

Total Current Assets

 

71,849

 

 

 

81,304

 

Property and equipment, net

 

23,805

 

 

 

24,956

 

Intangible assets, net

 

21,271

 

 

 

23,569

 

Goodwill

 

42,408

 

 

 

44,640

 

Other assets

 

4,407

 

 

 

4,093

 

Total Assets

$

163,740

 

 

$

178,562

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Accounts payable

$

2,561

 

 

$

2,786

 

Accrued liabilities:

 

 

 

 

 

Compensation

 

4,882

 

 

 

11,099

 

Accrued other

 

3,582

 

 

 

3,795

 

Deferred revenue

 

266

 

 

 

1,619

 

Income tax payable

 

1,894

 

 

 

1,244

 

Total Current Liabilities

 

13,185

 

 

 

20,543

 

Long-term debt, net

 

29,591

 

 

 

29,554

 

Deferred income taxes

 

1,595

 

 

 

1,785

 

Other long-term liabilities

 

7,600

 

 

 

7,783

 

Total Liabilities

 

51,971

 

 

 

59,665

 

Commitments and Contingencies (Note 11)

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

Series A Preferred stock — $.05 par value, 450 shares authorized; no shares issued and outstanding

 

 

 

 

 

Common stock — $.05 par value, 45,000 shares authorized; 14,294 and 14,325 shares
issued and outstanding as of December 31, 2024 and September 30, 2024, respectively

 

715

 

 

 

716

 

Additional paid-in capital

 

45,135

 

 

 

44,594

 

Accumulated other comprehensive loss

 

(6,143

)

 

 

(2,126

)

Retained earnings

 

72,062

 

 

 

75,713

 

Total Stockholders’ Equity

 

111,769

 

 

 

118,897

 

Total Liabilities and Stockholders’ Equity

$

163,740

 

 

$

178,562

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


 

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

 

Three Months Ended December 31,

 

 

2024

 

 

2023

 

(In thousands, except per share data)

(Unaudited)

 

Revenue:

 

 

 

 

 

Product sales

$

16,548

 

 

$

18,827

 

Royalties and license fees

 

10,634

 

 

 

9,179

 

Research, development and other

 

2,740

 

 

 

2,546

 

Total revenue

 

29,922

 

 

 

30,552

 

Operating costs and expenses:

 

 

 

 

 

Product costs

 

7,425

 

 

 

8,803

 

Research and development

 

8,941

 

 

 

8,664

 

Selling, general and administrative

 

15,174

 

 

 

12,537

 

Acquired intangible asset amortization

 

863

 

 

 

870

 

Total operating costs and expenses

 

32,403

 

 

 

30,874

 

Operating (loss) income

 

(2,481

)

 

 

(322

)

Other expense, net:

 

 

 

 

 

Interest expense, net

 

(882

)

 

 

(896

)

Foreign exchange gain (loss)

 

32

 

 

 

(45

)

Investment income, net

 

387

 

 

 

539

 

Other expense, net

 

(463

)

 

 

(402

)

(Loss) income before income taxes

 

(2,944

)

 

 

(724

)

Income tax expense

 

(707

)

 

 

(62

)

Net (loss) income

$

(3,651

)

 

$

(786

)

 

 

 

 

 

 

Basic net (loss) income per share

$

(0.26

)

 

$

(0.06

)

Diluted net (loss) income per share

$

(0.26

)

 

$

(0.06

)

 

 

 

 

 

 

Weighted average number of shares outstanding:

 

 

 

 

 

Basic

 

14,231

 

 

 

14,102

 

Diluted

 

14,231

 

 

 

14,102

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


 

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive (Loss) Income

 

 

Three Months Ended December 31,

 

 

2024

 

 

2023

 

(In thousands)

(Unaudited)

 

Net (loss) income

$

(3,651

)

 

$

(786

)

Other comprehensive (loss) income:

 

 

 

 

 

Derivative instruments:

 

 

 

 

 

Unrealized net gain (loss)

 

506

 

 

 

(620

)

Net gain reclassified to earnings

 

(29

)

 

 

(62

)

Net changes related to available-for-sale securities, net of tax

 

 

 

 

(8

)

Foreign currency translation adjustments

 

(4,494

)

 

 

2,797

 

Other comprehensive (loss) income

 

(4,017

)

 

 

2,107

 

Comprehensive (loss) income

$

(7,668

)

 

$

1,321

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5


 

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

 

Three Months Ended December 31, 2024 and 2023

 

 

(Unaudited)

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Retained

 

 

Stockholders’

 

(In thousands)

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Earnings

 

 

Equity

 

Balance at September 30, 2024

 

14,325

 

 

$

716

 

 

$

44,594

 

 

$

(2,126

)

 

$

75,713

 

 

$

118,897

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,651

)

 

 

(3,651

)

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

(4,017

)

 

 

 

 

 

(4,017

)

Issuance of common stock

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock options exercised, net

 

3

 

 

 

 

 

 

105

 

 

 

 

 

 

 

 

 

105

 

Purchase of common stock to pay
employee taxes

 

(33

)

 

 

(1

)

 

 

(1,307

)

 

 

 

 

 

 

 

 

(1,308

)

Stock-based compensation

 

 

 

 

 

 

 

1,743

 

 

 

 

 

 

 

 

 

1,743

 

Balance at December 31, 2024

 

14,294

 

 

$

715

 

 

$

45,135

 

 

$

(6,143

)

 

$

72,062

 

 

$

111,769

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2023

 

14,155

 

 

$

708

 

 

$

36,706

 

 

$

(4,759

)

 

$

87,255

 

 

$

119,910

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(786

)

 

 

(786

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

2,107

 

 

 

 

 

 

2,107

 

Issuance of common stock

 

102

 

 

 

5

 

 

 

(5

)

 

 

 

 

 

 

 

 

 

Common stock options exercised, net

 

7

 

 

 

 

 

 

39

 

 

 

 

 

 

 

 

 

39

 

Purchase of common stock to pay
employee taxes

 

(29

)

 

 

(1

)

 

 

(1,087

)

 

 

 

 

 

 

 

 

(1,088

)

Stock-based compensation

 

 

 

 

 

 

 

1,968

 

 

 

 

 

 

 

 

 

1,968

 

Balance at December 31, 2023

 

14,235

 

 

$

712

 

 

$

37,621

 

 

$

(2,652

)

 

$

86,469

 

 

$

122,150

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

6


 

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

 

Three Months Ended December 31,

 

 

2024

 

 

2023

 

(In thousands)

(Unaudited)

 

Operating Activities:

 

 

 

 

 

Net loss

$

(3,651

)

 

$

(786

)

Adjustments to reconcile net loss to net cash (used in) provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

2,083

 

 

 

2,333

 

Stock-based compensation

 

1,743

 

 

 

1,968

 

Noncash lease expense

 

208

 

 

 

183

 

Amortization of debt issuance costs

 

76

 

 

 

76

 

Provision for credit losses

 

76

 

 

 

6

 

Deferred taxes

 

(68

)

 

 

(97

)

Other

 

5

 

 

 

(123

)

Change in operating assets and liabilities:

 

 

 

 

 

Accounts receivable and contract assets

 

435

 

 

 

(3,430

)

Inventories

 

(93

)

 

 

401

 

Prepaids and other

 

(515

)

 

 

(788

)

Accounts payable

 

(216

)

 

 

(428

)

Accrued liabilities

 

(7,362

)

 

 

(7,084

)

Income taxes

 

738

 

 

 

99

 

Deferred revenue

 

(1,353

)

 

 

(1,122

)

Net cash (used in) provided by operating activities

 

(7,894

)

 

 

(8,792

)

Investing Activities:

 

 

 

 

 

Purchases of property and equipment

 

(302

)

 

 

(720

)

Purchases of available-for-sale securities

 

 

 

 

(9,750

)

Maturities of available-for-sale securities

 

4,000

 

 

 

2,000

 

Net cash (used in) provided by investing activities

 

3,698

 

 

 

(8,470

)

Financing Activities:

 

 

 

 

 

Issuance of common stock

 

105

 

 

 

39

 

Payments for taxes related to net share settlement of equity awards

 

(1,308

)

 

 

(1,088

)

Net cash (used in) provided by financing activities

 

(1,203

)

 

 

(1,049

)

Effect of exchange rate changes on cash and cash equivalents

 

(571

)

 

 

247

 

Net change in cash and cash equivalents

 

(5,970

)

 

 

(18,064

)

Cash and Cash Equivalents:

 

 

 

 

 

Beginning of period

 

36,115

 

 

 

41,419

 

End of period

$

30,145

 

 

$

23,355

 

Supplemental Information:

 

 

 

 

 

Cash paid for income taxes

$

 

 

$

 

Cash paid for interest

 

785

 

 

 

779

 

Noncash investing and financing activities:

 

 

 

 

 

Acquisition of property and equipment

 

141

 

 

 

43

 

Right-of-use assets obtained in exchange for operating lease liabilities

 

 

 

 

845

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

7


 

Surmodics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

Period Ended December 31, 2024

(Unaudited)

 

1. Organization

Description of Business

Surmodics, Inc. and subsidiaries (referred to as “Surmodics,” the “Company,” “we,” “us,” “our” and other like terms) is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic (“IVD”) immunoassay tests and microarrays. Surmodics develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. Our key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota.

On May 28, 2024, Surmodics entered into a Merger Agreement (the “Merger Agreement”) with BCE Parent, LLC, a Delaware limited liability company (“Parent”), and BCE Merger Sub, Inc., a Minnesota corporation and a wholly owned Subsidiary of Parent (“Merger Sub”), pursuant to which Surmodics will, subject to the terms and conditions thereof, be acquired by Parent for $43.00 per share in cash through the merger of Merger Sub with and into the Company, with the Company as the surviving corporation and a wholly owned subsidiary of Parent. See Note 13 Merger Agreement for additional information.

Basis of Presentation and Principles of Consolidation

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, 2024, and notes thereto included in our Annual Report on Form 10-K as filed with the SEC.

Use of Estimates

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 liabilities at the date of the condensed 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, 2024 are not necessarily indicative of the results that may be expected for the entire 2025 fiscal year.

New Accounting Pronouncements

Not Yet Adopted

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures. This guidance requires disclosure of incremental segment information on an annual and interim basis. This amendment is effective for our fiscal year ending September 30, 2025 and interim periods within our fiscal year ending September 30, 2026. We are currently assessing the impact of this guidance on our disclosures.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes: Improvements to Income Tax Disclosures. This guidance requires consistent categories and greater disaggregation of information in the rate reconciliation and disclosures of income taxes paid by jurisdiction. This amendment is effective for our fiscal year ending September 30, 2026 and interim periods within our fiscal year ending September 30, 2027. We are currently assessing the impact of this guidance on our disclosures.

No other new accounting pronouncement issued or effective during our fiscal year ending September 30, 2025, or is expected to have, a material impact on the Company’s condensed consolidated financial statements.

8


 

2. Revenue

The following table is a disaggregation of revenue within each reportable segment.

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Medical Device

 

 

Product sales

$

10,116

 

 

$

11,950

 

Royalties & license fees – performance coatings

 

9,383

 

 

 

8,208

 

License fees – SurVeil DCB

 

1,251

 

 

 

971

 

Research, development and other

 

2,531

 

 

 

2,416

 

Medical Device Revenue

 

23,281

 

 

 

23,545

 

In Vitro Diagnostics

 

 

 

 

 

Product sales

 

6,432

 

 

 

6,877

 

Research, development and other

 

209

 

 

 

130

 

In Vitro Diagnostics Revenue

 

6,641

 

 

 

7,007

 

Total Revenue

$

29,922

 

 

$

30,552

 

Contract assets totaled $10.7 million and $10.6 million as of December 31, 2024 and September 30, 2024, respectively, and was reported in contract assets, current and other assets, noncurrent (Note 5) on the condensed consolidated balance sheets. Fluctuations in the balance of contract assets result primarily from (i) fluctuations in the sales volume of performance coating royalties and license fees earned, but not collected, at each balance sheet date due to payment timing and contractual changes in the normal course of business; and (ii) starting in fiscal 2024, sales-based profit-sharing earned, but not collected, related to a collaborative arrangement (Note 3).

Deferred revenue totaled $0.3 million and $1.6 million as of December 31, 2024 and September 30, 2024, respectively, on the condensed consolidated balance sheets and was primarily related to a collaborative arrangement (Note 3). For the three months ended December 31, 2024 and 2023, the total amount of revenue recognized that was included in the respective beginning of fiscal year balances of deferred revenue on the condensed consolidated balance sheets totaled $1.3 million and $1.0 million, respectively.

3. Collaborative Arrangement

On February 26, 2018, the Company entered into an agreement with Abbott Vascular, Inc. (“Abbott”) with respect to one of the device products in our Medical Device reportable segment, the SurVeil™ drug-coated balloon (“DCB”) for treatment of the superficial femoral artery (the “Abbott Agreement”). In June 2023, the SurVeil DCB received U.S. Food and Drug Administration (“FDA”) premarket approval (“PMA”) and may now be marketed and sold in the U.S. by Abbott.

SurVeil DCB License Fees

Under the Abbott Agreement, Surmodics is responsible for conducting all necessary clinical trials, including completion of the ongoing, five-year TRANSCEND pivotal clinical trial of the SurVeil DCB. The Company has received payments totaling $87.8 million for achievement of clinical and regulatory milestones under the Abbott Agreement, which consisted of the following: (i) a $25 million upfront fee in fiscal 2018, (ii) a $10 million milestone payment in fiscal 2019, (iii) a $10.8 million milestone payment in fiscal 2020, (iv) a $15 million milestone payment in fiscal 2021, and (v) a $27 million milestone payment in the third quarter of fiscal 2023 upon receipt of PMA for the SurVeil DCB from the FDA. There are no remaining contingent or other milestone payments under the Abbott Agreement.

License fee revenue on milestone payments received under the Abbott Agreement is recognized using the cost-to-cost method based on total costs incurred to date relative to total expected costs for the TRANSCEND pivotal clinical trial, which is expected to be competed in fiscal 2025. See Note 2 Revenue for SurVeil DCB license fee revenue recognized in our Medical Device reportable segment.

As of December 31, 2024, deferred revenue on the condensed consolidated balance sheets included $0.3 million from upfront and milestone payments received under the Abbott Agreement. This represented the Company’s remaining performance obligations and is expected to be recognized as revenue in the second quarter of fiscal 2025 as services, principally the TRANSCEND clinical trial, are completed.

9


 

SurVeil DCB Product Sales

Under the Abbott Agreement, we supply commercial units of the SurVeil DCB to Abbott, and Abbott has exclusive worldwide distribution rights. During the first quarter of fiscal 2024, we commenced shipment of commercial units of the SurVeil DCB to Abbott. We recognize revenue from the sale of commercial units of the SurVeil DCB to Abbott at the time of shipment in product sales on the condensed consolidated statements of operations. The amount of SurVeil DCB product sales revenue recognized includes (i) the contractual transfer price per unit and (ii) an estimate of Surmodics’ share of net profits resulting from product sales by Abbott to third parties pursuant to the Abbott Agreement (“estimated SurVeil DCB profit-sharing”). On a quarterly basis, Abbott (i) reports to us its third-party sales of the SurVeil DCB the quarter after those sales occur, which may occur within two years following shipment based on the product’s current shelf life; and (ii) reports to us and pays the actual amount of profit-sharing. Estimated SurVeil DCB profit-sharing represents variable consideration and is recorded in contract assets, current and other assets, noncurrent on the condensed consolidated balance sheets. We estimate variable consideration as the most-likely amount to which we expect to be entitled, and we include estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue will not occur when the uncertainty associated with the variable consideration is resolved. Significant judgment is required in estimating the amount of variable consideration to recognize when assessing factors outside of Surmodics’ influence, such as limited availability of third-party information, expected duration of time until resolution, and limited relevant past experience.

4. Fair Value Measurements

Assets and liabilities measured at fair value on a recurring basis by level of the fair value hierarchy were as follows:

 

 

December 31, 2024

 

(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 (1)

$

 

 

$

23,228

 

 

$

 

 

$

23,228

 

Available-for-sale securities (1)

 

 

 

 

 

 

 

 

 

 

 

Total assets

$

 

 

$

23,228

 

 

$

 

 

$

23,228

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap (2)

 

 

 

 

196

 

 

 

 

 

 

196

 

Total liabilities

$

 

 

$

196

 

 

$

 

 

$

196

 

 

 

September 30, 2024

 

(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 (1)

$

 

 

$

29,334

 

 

$

 

 

$

29,334

 

Available-for-sale securities (1)

 

 

 

 

3,997

 

 

 

 

 

 

3,997

 

Total assets

$

 

 

$

33,331

 

 

$

 

 

$

33,331

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap (2)

$

 

 

$

673

 

 

$

 

 

$

673

 

Total liabilities

$

 

 

$

673

 

 

$

 

 

$

673

 

(1)
Fair value of cash equivalents (money market funds) and available-for-sale securities (commercial paper and corporate bond securities) was based on quoted vendor prices and broker pricing where all significant inputs are observable.
(2)
Fair value of interest rate swap is based on forward-looking, one-month term secured overnight financing rate (“Term SOFR”) spot rates and interest rate curves (Note 7).

10


 

5. Supplemental Balance Sheet Information

Investments — 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, 2024

 

(In thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Commercial paper and corporate bonds

 

$

 

 

$

 

 

$

 

 

$

 

Available-for-sale securities

 

$

 

 

$

 

 

$

 

 

$

 

 

 

 

September 30, 2024

 

(In thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Commercial paper and corporate bonds

 

$

3,997

 

 

$

 

 

$

 

 

$

3,997

 

Available-for-sale securities

 

$

3,997

 

 

$

 

 

$

 

 

$

3,997

 

Inventories

Inventories consisted of the following components:

 

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Raw materials

$

8,793

 

 

$

8,505

 

Work-in process

 

2,268

 

 

 

2,476

 

Finished products

 

4,200

 

 

 

4,187

 

Inventories

$

15,261

 

 

$

15,168

 

Prepaids and Other Assets, Current

Prepaids and other current assets consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Prepaid expenses and other

$

3,905

 

 

$

2,752

 

Irish research and development credits receivable

 

100

 

 

 

108

 

Prepaids and other

$

4,005

 

 

$

2,860

 

 

11


 

Intangible Assets

Intangible assets consisted of the following:

 

December 31, 2024

 

(Dollars in thousands)

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

9.3

 

 

$

11,066

 

 

$

(10,321

)

 

$

745

 

Developed technology

 

11.9

 

 

 

33,452

 

 

 

(14,215

)

 

 

19,237

 

Patents and other

 

14.9

 

 

 

2,338

 

 

 

(1,629

)

 

 

709

 

Total definite-lived intangible assets

 

 

 

 

46,856

 

 

 

(26,165

)

 

 

20,691

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

580

 

 

 

 

 

 

580

 

Intangible assets, net

 

 

 

$

47,436

 

 

$

(26,165

)

 

$

21,271

 

 

 

September 30, 2024

 

(Dollars in thousands)

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

9.3

 

 

$

11,870

 

 

$

(10,844

)

 

$

1,026

 

Developed technology

 

11.9

 

 

 

35,433

 

 

 

(14,222

)

 

 

21,211

 

Patents and other

 

14.9

 

 

 

2,338

 

 

 

(1,586

)

 

 

752

 

Total definite-lived intangible assets

 

 

 

 

49,641

 

 

 

(26,652

)

 

 

22,989

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

580

 

 

 

 

 

 

580

 

Intangible assets, net

 

 

 

$

50,221

 

 

$

(26,652

)

 

$

23,569

 

Intangible asset amortization expense was $0.9 million for each of the three months ended December 31, 2024 and 2023 . Based on the intangible assets in service as of December 31, 2024, estimated amortization expense for future fiscal years was as follows:

(In thousands)

 

 

Remainder of 2025

$

2,694

 

2026

 

2,741

 

2027

 

2,498

 

2028

 

2,488

 

2029

 

2,488

 

2030

 

2,262

 

Thereafter

 

5,520

 

Definite-lived intangible assets

$

20,691

 

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

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, 2024

$

8,010

 

 

$

36,630

 

 

$

44,640

 

Currency translation adjustment

 

 

 

 

(2,232

)

 

 

(2,232

)

Goodwill as of December 31, 2024

$

8,010

 

 

$

34,398

 

 

$

42,408

 

 

12


 

Other Assets, Noncurrent

Other noncurrent assets consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Operating lease right-of-use assets

$

2,820

 

 

$

3,028

 

Contract asset (1)

 

803

 

 

 

689

 

Other

 

784

 

 

 

376

 

Other assets

$

4,407

 

 

$

4,093

 

(1)
As of December 31, 2024 and September 30, 2024, the noncurrent portion of the contract asset associated with estimated SurVeil DCB profit-sharing (Note 3).

Accrued Other Liabilities

Accrued other liabilities consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Accrued professional fees

$

869

 

 

$

563

 

Accrued clinical study expense

 

377

 

 

 

499

 

Accrued purchases

 

828

 

 

 

1,023

 

Operating lease liabilities, current portion

 

1,049

 

 

 

1,040

 

Other

 

459

 

 

 

670

 

Total accrued other liabilities

$

3,582

 

 

$

3,795

 

Other Long-term Liabilities

Other long-term liabilities consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Deferred consideration (1)

$

1,669

 

 

$

1,661

 

Unrecognized tax benefits (2)

 

3,263

 

 

 

3,176

 

Operating lease liabilities, less current portion

 

2,387

 

 

 

2,648

 

Other

 

281

 

 

 

298

 

Other long-term liabilities

$

7,600

 

 

$

7,783

 

(1)
Deferred consideration consisted of the present value of a guaranteed payment to be made in connection with the fiscal 2021 Vetex acquisition (Note 11).
(2)
Unrecognized tax benefits include accrued interest and penalties, if applicable (Note 10).

6. Debt

Debt consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Revolving Credit Facility, Term SOFR + 3.00%, maturing October 1, 2027

$

5,000

 

 

$

5,000

 

Tranche 1 Term Loans, Term SOFR +5.75%, maturing October 1, 2027

 

25,000

 

 

 

25,000

 

Long-term debt, gross

 

30,000

 

 

 

30,000

 

Less: Unamortized debt issuance costs

 

(409

)

 

 

(446

)

Long-term debt, net

$

29,591

 

 

$

29,554

 

 

13


 

On October 14, 2022, the Company entered into a secured revolving credit facility and secured term loan facilities pursuant to a Credit, Security and Guaranty Agreement (the “MidCap Credit Agreement”) with Mid Cap Funding IV Trust, as agent, and MidCap Financial Trust, as term loan servicer and the lenders from time to time party thereto. The MidCap Credit Agreement provides for availability under a secured revolving line of credit of up to $25.0 million (the “Revolving Credit Facility”). Availability under the Revolving Credit Facility is subject to a borrowing base.

The MidCap Credit Agreement also provided for up to $75.0 million in term loans (the “Term Loans”), consisting of a $25.0 million Tranche 1 (“Tranche 1”) and a $50.0 million Tranche 2 (“Tranche 2”), which was available until December 31, 2024. The Company did not draw any amounts under Tranche 2 and the Tranche 2 commitment expired on December 31, 2024. Upon closing, the Company borrowed $25.0 million of Tranche 1, borrowed $5.0 million on the Revolving Credit Facility, and used approximately $10.0 million of the proceeds to repay borrowings under the revolving credit facility with Bridgewater Bank. The Company intends to use the remaining proceeds to fund working capital needs and for other general corporate purposes, as permitted under the MidCap Credit Agreement.

Pursuant to the MidCap Credit Agreement, the Company provided a first priority security interest in all existing and future acquired assets, including intellectual property and real estate, owned by the Company. The MidCap Credit Agreement contains certain covenants that limit the Company’s ability to engage in certain transactions. Subject to certain limited exceptions, these covenants limit the Company’s ability to, among other things:

create, incur, assume or permit to exist any additional indebtedness, or create, incur, allow or permit to exist any additional liens;
enter into any amendment or other modification of certain agreements;
effect certain changes in the Company’s business, fiscal year, management, entity name or business locations;
liquidate or dissolve, merge with or into, or consolidate with, any other company;
pay cash dividends on, make any other distributions in respect of, or redeem, retire or repurchase, any shares of the Company’s capital stock;
make certain investments, other than limited permitted acquisitions; and
enter into transactions with the Company’s affiliates.

The MidCap Credit Agreement also contains customary indemnification obligations and customary events of default, including, among other things, (i) non-payment, (ii) breach of warranty, (iii) non-performance of covenants and obligations, (iv) default on other indebtedness, (v) judgments, (vi) change of control, (vii) bankruptcy and insolvency, (viii) impairment of security, (ix) termination of a pension plan, (x) regulatory matters, and (xi) material adverse effect.

In the event of default under the MidCap Credit Agreement, the Company would be required to pay interest on principal and all other due and unpaid obligations at the current rate in effect plus 2%.

Borrowings under the MidCap Credit Agreement bear interest at Term SOFR as published by CME Group Benchmark Administration Limited plus 0.10% (“Adjusted Term SOFR”). The Revolving Credit Facility bears interest at an annual rate equal to 3.00% plus the greater of Adjusted Term SOFR or 1.50%, and the Term Loans bear interest at an annual rate equal to 5.75% plus the greater of Adjusted Term SOFR or 1.50%. The Company is required to make monthly interest payments on the Revolving Credit Facility with the entire principal payment due at maturity. The Company is required to make 48 monthly interest payments on the Term Loans beginning on November 1, 2022 (the “Interest-Only Period”). If the Company is in covenant compliance at the end of the Interest-Only Period, the Company will have the option to extend the Interest-Only Period through maturity with the entire principal payment due at maturity. If the Company is not in covenant compliance at the end of the Interest-Only Period, the Company is required to make 12 months of straight-line amortization payments with the entire principal amount due at maturity.

Subject to certain limitations, the Term Loans have a prepayment fee for payments made prior to the maturity date equal to 1.0% of the prepaid principal amount for the third year following the closing date and thereafter. In addition, if the Revolving Credit Facility is terminated in whole or in part prior to the maturity date, the Company must pay a prepayment fee equal to 1.0% of the terminated commitment amount for the third year following the closing date of the MidCap Credit Agreement and thereafter. The Company is also required to pay a full exit fee at the time of maturity or full prepayment event equal to 2.5% of the aggregate principal amount of the Term Loans made pursuant to the MidCap Credit Agreement and a partial exit fee at the time of any partial prepayment event equal to 2.5% of the amount prepaid. This exit fee is accreted over the remaining term of the Term Loans. The Company also is obligated to pay customary origination fees at the time of each funding of the Term Loans and a customary annual administrative fee based on the amount borrowed under the Term Loan, due on an annual basis. The customary fees on the Revolving Credit Facility

14


 

include (i) an origination fee based on the commitment amount, which was paid on the closing date, (ii) an annual collateral management fee of 0.50% per annum based on the outstanding balance of the Revolving Credit Facility, payable monthly in arrears and (iii) an unused line fee of 0.50% per annum based on the average unused portion of the Revolving Credit Facility, payable monthly in arrears. The Company must also maintain a minimum balance of no less than 20% of availability under the Revolving Credit Facility or a minimum balance fee applies of 0.50% per annum. Expenses recognized for fees for the Revolving Credit Facility and Term Loans are reported in interest expense, net on the condensed consolidated statements of operations.

7. Derivative Financial Instruments

As of December 31, 2024 and September 30, 2024, derivative financial instruments on the condensed consolidated balance sheets consisted of a fixed-to-variable interest rate swap to mitigate exposure to interest rate increases related to our Term Loans (“interest rate swap”). The interest rate swap has been designated as a cash flow hedge. See Note 6 Debt for further information on our financing arrangements. The net fair value of designated hedge derivatives subject to master netting arrangements reported on the condensed consolidated balance sheets was as follows:

 

Asset (Liability)

(In thousands)

Gross Recognized Amount

 

 

Gross Offset Amount

 

 

Net Amount Presented

 

 

Cash Collateral Receivable

 

 

Net Amount Reported

 

 

Balance Sheet Location

December 31, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap

$

(196

)

 

$

 

 

$

(196

)

 

$

436

 

 

$

240

 

 

Other assets, noncurrent

September 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap

$

(673

)

 

$

 

 

$

(673

)

 

$

625

 

 

$

(48

)

 

Other long-term liabilities

The pretax amounts recognized in accumulated other comprehensive loss (“AOCL”) for designated hedge derivative instruments were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

 

2024

 

 

2023

 

Beginning unrealized net (loss) gain in AOCL

 

$

(673

)

 

$

183

 

Net gain (loss) recognized in other comprehensive (loss) income

 

 

506

 

 

 

(620

)

Net gain (loss) reclassified into interest expense

 

 

(29

)

 

 

(62

)

Ending unrealized (loss) gain in AOCL

 

$

(196

)

 

$

(499

)

 

8. Stock-based Compensation Plans

The Company has stock-based compensation plans approved by its 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)

2024

 

 

2023

 

Product costs

$

59

 

 

$

72

 

Research and development

 

301

 

 

 

370

 

Selling, general and administrative

 

1,383

 

 

 

1,526

 

Total

$

1,743

 

 

$

1,968

 

As of December 31, 2024, unrecognized compensation costs related to non-vested awards totaled approximately $9.1 million, which is expected to be recognized over a weighted average period of approximately 2.0 years.

15


 

Stock Option Awards

The Company awards stock options to officers, directors and key employees and uses the Black-Scholes option pricing model to determine the fair value of stock options as of the date of each grant. Stock option grant activity was as follows:

 

Three Months Ended December 31,

 

 

2024

 

 

2023

 

Stock option grant activity:

 

 

 

 

 

Stock options granted

 

-

 

 

 

250,000

 

Weighted average grant date fair value

$

-

 

 

$

15.82

 

Weighted average exercise price

$

-

 

 

$

33.64

 

Restricted Stock Awards

During the three months ended December 31, 2024, the Company did not award any shares of restricted stock. During the three months ended December 31, 2023, the Company awarded 98,000 shares of restricted stock to certain key employees and officers with a weighted average grant date fair value per share of $33.64. Restricted stock is valued based on the market value of the shares as of the date of grant.

Restricted Stock Unit Awards

During the three months ended December 31, 2024, the Company did not award any restricted stocks (“RSU’s”). During the three months ended December 31, 2023, the Company awarded 5,000 RSU’s to directors and key employees in foreign jurisdictions with a weighted average grant date fair value per unit of $33.64. RSUs are valued based on the market value of the shares as of the date of grant.

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 each of the three months ended December 31, 2024 and 2023 no shares were issued under the ESPP.

 

9. 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 (loss) 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 RSUs.

The calculation of diluted loss per share excluded 0.1 million or less in weighted-average shares for each of the three-month periods ended December 31, 2024 and 2023, as their effect was anti-dilutive. Basic and diluted weighted average shares outstanding were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Basic weighted average shares outstanding

 

14,231

 

 

 

14,102

 

Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units

 

 

 

 

 

Diluted weighted average shares outstanding

 

14,231

 

 

 

14,102

 

 

16


 

10. Income Taxes

For interim income tax reporting, the Company estimates its full-year 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 reported income tax expense of $(0.7) million and $(0.1) million for the three months ended December 31, 2024 and 2023, respectively.

Beginning in our fiscal 2023, certain research and development (“R&D”) costs are required to be capitalized and amortized over a five-year period under the Tax Cuts and Jobs Act enacted in December 2017. This change impacts the expected U.S. federal and state income tax expense and cash taxes paid and to be paid for our fiscal 2025 and 2024.
Since September 30, 2022, we have maintained a full valuation allowance against U.S. net deferred tax assets. As a result, we are no longer recording a tax benefit associated with U.S. pretax losses and incremental deferred tax assets.
Recurring items cause our effective tax rate to differ from the U.S. federal statutory rate of 21%, including foreign-derived intangible income (“FDII”) deductions in the U.S., U.S. federal and Irish R&D credits, Irish and U.S. state tax rates, excess tax benefits associated with stock-based compensation, and non-deductible merger-related charges (Note 13).

A valuation allowance is required to be recognized against deferred tax assets if, based on the available evidence, it is more likely than not (defined as a likelihood of more than 50%) that all or a portion of such assets will not be realized. We apply judgment to consider the relative impact of negative and positive evidence, and the weight given to negative and positive evidence is commensurate with the extent to which such evidence can be objectively verified. Objective historical evidence, such as cumulative three-year pre-tax losses adjusted for permanent adjustments, is given greater weight than subjective positive evidence, such as forecasts of future earnings. The more objective negative evidence that exists limits our ability to consider other, potentially positive, subjective evidence, such as our future earnings projections. Based on our evaluation of all available positive and negative evidence, and by placing greater weight on the objectively verifiable evidence, we determined, as of December 31, 2024 and September 30, 2024, that it is more likely than not that our net U.S. deferred tax assets will not be realized. Due to significant estimates used to establish the valuation allowance and the potential for changes in facts and circumstances, it is reasonably possible that we will be required to record additional adjustments to the valuation allowance in future reporting periods that could have a material effect on our results of operations.

Discrete tax benefits related to stock-based compensation awards vested, expired, canceled and exercised was $0.1 million or less for each of the three months ended December 31, 2024 and 2023. The total amount of unrecognized tax benefits, excluding interest and penalties that, if recognized, would affect the effective tax rate was $3.2 million and $2.8 million as of December 31, 2024 and September 30, 2024, respectively. Interest and penalties related to unrecognized tax benefits are recorded in income tax expense.

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. The Internal Revenue Service commenced an examination of the Company’s fiscal 2019 U.S. federal tax return in fiscal 2022; the examination has been completed. U.S. federal income tax returns for years prior to fiscal 2020 are no longer subject to examination by federal tax authorities. For tax returns for U.S. state and local jurisdictions, the Company is no longer subject to examination for tax years generally before fiscal 2015. For tax returns for non-U.S. jurisdictions, the Company is no longer subject to income tax examination for years prior to 2020. Additionally, the Company has been indemnified of liability for any taxes relating to the fiscal 2021 acquisition of Vetex Medical Limited (“Vetex”) and the fiscal 2016 acquisitions of Creagh Medical, Ltd and NorMedix, Inc. for periods prior to the 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, 2024 and September 30, 2024.

11. Commitments and Contingencies

Asset Acquisition. 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 fiscal 2020, $1.0 million in fiscal 2021, $0.5 million in fiscal 2022, $1.0 million in fiscal 2023, and $0.9 million in fiscal 2024. An additional $1.0 million payment is contingent upon the achievement of a certain regulatory milestone within a contingency period ending in 2033.

Vetex Acquisition. In fiscal 2021, Surmodics acquired all of the outstanding shares of Vetex with an upfront cash payment of $39.9 million. The Company paid the sellers $1.8 million in the fourth quarter of fiscal 2024. The Company is obligated to pay an additional installment of $1.8 million in fiscal 2027. An additional $3.5 million in payments is contingent upon the achievement of certain product development and regulatory milestones within a contingency period ending in fiscal 2027.

17


 

12. Segment Information

Segment revenue, operating (loss) income, and depreciation and amortization were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Revenue:

 

 

 

 

 

Medical Device

$

23,281

 

 

$

23,545

 

In Vitro Diagnostics

 

6,641

 

 

 

7,007

 

Total revenue

$

29,922

 

 

$

30,552

 

 

 

 

 

 

 

Operating (loss) income:

 

 

 

 

 

Medical Device

$

161

 

 

$

(224

)

In Vitro Diagnostics

 

2,922

 

 

 

3,124

 

Total segment operating income

 

3,083

 

 

 

2,900

 

Corporate

 

(5,564

)

 

 

(3,222

)

Total operating (loss) income

$

(2,481

)

 

$

(322

)

 

 

 

 

 

 

Depreciation and amortization:

 

 

 

 

 

Medical Device

$

1,924

 

 

$

2,054

 

In Vitro Diagnostics

 

91

 

 

 

97

 

Corporate

 

68

 

 

 

182

 

Total depreciation and amortization

$

2,083

 

 

$

2,333

 

The Corporate category includes expenses that are not fully allocated to the Medical Device and In Vitro Diagnostics segments. These Corporate costs are related to administrative corporate functions, such as executive management, corporate accounting, information technology, legal, human resources and Board of Directors. Corporate may also include expenses, such as litigation and merger-and-acquisition-related costs, which are not specific to a segment and thus not allocated to the reportable 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.

13. Merger Agreement

On May 28, 2024, Surmodics entered into the Merger Agreement with Parent and Merger Sub (Note 1). Pursuant to the Merger Agreement, and subject to the terms and conditions thereof, Merger Sub will merge (the “Merger”) with and into the Company, with the Company as the surviving corporation and a wholly owned subsidiary of Parent. At the effective time of the Merger (the “Effective Time”), each share of common stock of the Company then outstanding (other than (1) those shares owned by Merger Sub, Parent, the Company, or any direct or indirect wholly owned subsidiary of Parent or the Company (which will be cancelled without any consideration), (2) any shares outstanding immediately prior to the Effective Time and held of record or beneficially by a Person who has not voted in favor of approval of this Agreement and who is entitled to demand and properly demands and perfects such holder’s dissenter’s rights with respect to such shares, and (3) any shares that have been issued as a restricted stock award pursuant to any of the Stock Incentive Plans (as defined in the Merger Agreement) and that remains unvested and subject to forfeiture thereunder (“Restricted Shares”) (which will be treated as described below)) will be converted into the right to receive $43.00 in cash, without interest (the “Merger Consideration”). The Merger is not subject to a financing condition. If the Merger is consummated, shares of our common stock will be delisted from The Nasdaq Stock Market and deregistered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

During the three months ended December 31, 2024, we incurred a total of $2.3 million in Merger-related charges, which we reported within selling, general and administrative expenses on the condensed consolidated statements of operations.

Merger Consideration

The Merger Agreement provides that, at the Effective Time, each of the Company’s then outstanding equity awards will be treated as follows: (1) each restricted stock unit or deferred stock unit that has been issued pursuant to any of the Stock Incentive Plans will be cancelled in exchange for an amount in cash equal to the Merger Consideration net of any taxes withheld pursuant to the Merger Agreement; (2) each Restricted Share will be cancelled in exchange for an amount in cash equal to the Merger Consideration, net of

18


 

any taxes withheld pursuant to the Merger Agreement; and (3) each unexercised option to acquire Company common stock will be (i) if the Merger Consideration for such option is equal to or greater than the exercise price per share of Company common stock subject to such option, cancelled in exchange for an amount in cash equal to the excess, if any, of the Merger Consideration over the exercise price per share of Company common stock subject to such option multiplied by the number of shares of Company common stock subject to such option, and (ii) if the Merger Consideration for such option is less than the exercise price per share of Company common stock subject to such option, cancelled for no consideration.

Conditions

The obligations of the parties to consummate the Merger are subject to the satisfaction or waiver of closing conditions set forth in the Merger Agreement, including (1) the approval of the Company’s shareholders, (2) the expiration or termination of any waiting period applicable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), (3) the absence of a “Company Material Adverse Effect” (as defined in the Merger Agreement) with respect to the Company and (4) other customary closing conditions, including the absence of any injunction or other legal restraint or prohibition that would prevent or prohibit the consummation of the Merger.

The Merger was approved by Surmodics’ shareholders at a special meeting on August 13, 2024. On the same date, the Company announced that it and an affiliate of Parent each received a request for additional information and documentary materials (a “Second Request”) from the U.S. Federal Trade Commission (“FTC”) in connection with the Merger. As of December 31, 2024, the Merger remains subject to the expiration or termination of a voluntary agreement with the FTC not to consummate the Merger for a period of time following substantial compliance with the Second Requests. The Company and Parent remain engaged with the FTC with the goal of consummating the Merger in accordance with the definitive agreement for the Merger in the Company’s second fiscal quarter ending March 31, 2025 if all the remaining closing conditions are satisfied.

Termination Rights & Fees

The Merger Agreement may be terminated with the mutual written consent of Parent and the Company and also contains termination rights for each of Parent and the Company, including, among others, (1) if the Merger has not been consummated by February 28, 2025 (which date may be extended one or more times, for up to nine additional months in total, under specified circumstances), (2) if a final and non-appealable judgment or law makes consummation of the Merger illegal or prevents the consummation of the Merger, (3) if the required approval of the Company’s shareholders is not obtained, or (4) in the case of a material uncured breach by the other party, in each case as further described in, and subject to the terms and conditions of, the Merger Agreement. Parent may terminate the Merger Agreement in certain circumstances generally related to an adverse change in the Company’s board of directors’ recommendation in favor of the Merger and, as further described below, the Company may terminate the Merger Agreement to accept a Superior Proposal, as further described in, and subject to the terms and conditions of, the Merger Agreement.

Upon termination of the Merger Agreement under specified circumstances, generally relating to alternative acquisition proposals or an adverse change in the Company’s board of directors’ recommendation in favor of the Merger, the Company would be required to pay Parent a termination fee of $20.4 million. Upon termination of the Merger Agreement under specified circumstances, generally relating to a failure of the Merger to be completed due to certain regulatory impediments, Parent would be required to pay the Company a reverse termination fee of $50.2 million. In certain other circumstances, generally related to a failure by Parent to consummate the Merger when required to do so pursuant to the terms of the Merger Agreement, Parent would be required to pay the Company a reverse termination fee of $47.0 million. The Merger Agreement also contains restrictions on the Company’s ability to seek specific performance of Parent’s obligation to consummate the Merger and generally limits the aggregate liability of Parent for a breach of the Merger Agreement to the amount of the termination fee payable by Parent to the Company.

The foregoing description of the Merger and the Merger Agreement does not purport to be and is not complete and is subject to and qualified in its entirety by reference to the full text of the Merger Agreement.

19


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis provides information management believes is useful in understanding the operating results, cash flows and financial condition of Surmodics. The discussion should be read in conjunction with both the unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations, each included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2024. This discussion contains various “Forward-Looking Statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We refer readers to the statement entitled “Forward-Looking Statements” located at the end of this Item 2.

Overview

Surmodics, Inc. (referred to as “Surmodics,” the “Company,” “we,” “us,” “our” and other like terms) is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic (“IVD”) immunoassay tests and microarrays. Surmodics develops and commercializes highly differentiated vascular intervention 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 modification and drug-delivery coating technologies, along with its device design, development and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota.

Merger Agreement

As described more fully under Part I, Item 1, Note 13 Merger Agreement, on May 28, 2024, we entered into a Merger Agreement with BCE Parent, LLC, a Delaware limited liability company (“Parent”), and BCE Merger Sub, Inc., a Minnesota corporation and a wholly owned Subsidiary of Parent (“Merger Sub”), pursuant to which we will, subject to the terms and conditions of the Merger Agreement, be acquired by Parent for $43.00 per share in cash through the merger of Merger Sub with and into us (the “Merger”), with Surmodics as the surviving corporation and a wholly owned subsidiary of Parent. The Merger remains subject to customary closing conditions, including required regulatory approval. If the Merger is consummated, shares of our common stock will be delisted from The Nasdaq Stock Market and deregistered under the Exchange Act.

During the three months ended December 31, 2024, we incurred a total of $2.3 million in merger-related charges, which we reported within selling, general and administrative expense on the condensed consolidated statements of operations.

Vascular Intervention Medical Device Platforms

Within our Medical Device segment, we develop and manufacture our own proprietary vascular intervention medical device products, which leverage our expertise in performance coating technologies, product design and engineering capabilities. We believe our strategy of developing our own medical device products has increased, and will continue to increase, our relevance in the medical device industry. This strategy is key to our future growth and profitability, providing us with the opportunity to capture more revenue and operating margin with vascular intervention device products than we would by licensing our device-enabling technologies.

Highlighted below are select medical device products within our development pipeline that are our focus for commercialization and development efforts. For our drug-coated balloon (“DCB") platform, we commercialized our SurVeil™ DCB through a distribution arrangement with Abbott Vascular, Inc. (“Abbott”). For both our thrombectomy and radial access platforms, we are pursuing commercialization via a direct sales strategy leveraging a small team of experienced sales professionals and clinical specialists. Beginning in fiscal 2022, we began to see modest, but meaningful and growing revenue associated with the adoption, utilization and sales of our Pounce™ and Sublime™ platform products.

Drug-coated Balloon Platform

Surmodics’ DCBs are designed for vascular interventions to treat peripheral arterial disease (“PAD”), a condition that causes a narrowing of the blood vessels supplying the extremities.

SurVeil DCB is a paclitaxel-coated DCB to treat PAD in the upper leg (superficial femoral artery), which utilizes a proprietary paclitaxel drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. In June 2023, the SurVeil DCB received U.S. Food and Drug Administration (“FDA”) premarket approval (“PMA”) and may now be marketed and sold in the U.S. by Abbott under our exclusive worldwide distribution agreement for the product (the “Abbott Agreement”). The SurVeil DCB also has the necessary regulatory approval for commercialization in the European Union.

20


 

In the first quarter of fiscal 2024, we completed shipment of Abbott’s initial stocking order of commercial units of the SurVeil DCB, resulting in recognition of product sales, which included both (i) the contractual transfer price, and (ii) an estimate of Surmodics’ share of net profits resulting from product sales by Abbott to third parties. Beginning in January 2024, the SurVeil DCB is a commercial product available in the U.S. through Abbott. Throughout fiscal 2024 and the first quarter of fiscal 2025, we continued to manufacture and ship commercial units to Abbott in support of Abbott’s commercialization of the product.

SundanceTM DCB is a sirolimus-coated DCB used for the treatment of below-the-knee PAD. We completed six-month patient follow-up visits in the fourth quarter of fiscal 2021 for the SWING first-in-human, 35-patient clinical study of our Sundance DCB. SWING study data at 24 months have demonstrated an excellent safety profile and promising signals of potential performance. We continue to evaluate our strategy for further clinical investment in the Sundance DCB based on the experience we have gained from the PMA application process for the SurVeil DCB and market interest.

Thrombectomy Systems

We have successfully developed, internally and through acquisitions, multiple FDA 510(k)-cleared mechanical thrombectomy devices, which require no capital equipment, for the non-surgical removal of thrombi and emboli (clots) from the peripheral arterial and venous vasculatures, while minimizing the need for thrombolytics. We believe that the ease of use, intuitive design, and performance of our thrombectomy systems make these products attractive first-line treatment options for interventionalists.

Pounce Thrombectomy Platform, indicated for the peripheral arterial vasculature, is a suite of mechanical thrombectomy systems designed for the capture and non-surgical removal of thrombi and emboli (clots) without the need for capital equipment or aspiration while minimizing the use of thrombolytics. Two different-sized systems are commercially available.

The original Pounce (mid profile) Thrombectomy System is indicated for use in peripheral arterial vessels 3.5 mm to 6 mm in diameter, such as those found above the knee. Commercial sales of the Pounce Thrombectomy System began in fiscal 2022.

The Pounce LP (Low Profile) Thrombectomy System is indicated for use in peripheral arterial vessels 2 mm to 4 mm in diameter, such as those found below the knee. The Pounce LP Thrombectomy System received FDA 510(k) regulatory clearance in fiscal 2023, and we began limited market evaluations of the product in the first quarter of fiscal 2024. In the third quarter of fiscal 2024, we completed limited market evaluations for the Pounce LP Thrombectomy System, and the product was commercially launched.

The Pounce XL Thrombectomy System is indicated for use in peripheral arterial vessels 5.5 mm to 10 mm in diameter, making it suitable for iliac, femoral, and other arteries within this range. The Pounce XL Thrombectomy System received FDA 510(k) regulatory clearance in the fourth quarter of fiscal 2024. We have initiated, and plan to continue, limited market evaluations of the product in the first half of fiscal 2025, with commercialization following the completion of the limited market evaluations.

Pounce Venous Thrombectomy System is a mechanical thrombectomy system indicated for mechanical de-clotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature. The Pounce Venous System is designed to remove mixed-morphology, wall-adherent venous clot in a single session, minimizing the need for thrombolytics and without the need for capital equipment. We conducted limited market evaluations of the Pounce Venous Thrombectomy System in fiscal 2023 and in the first half of fiscal 2024 to obtain physician feedback across a variety of cases and clinical conditions. In the second quarter of fiscal 2024, we completed limited market evaluations for the Pounce Venous Thrombectomy System, and the product was commercially launched.

Sublime Radial Access Platform

We have successfully developed and received FDA 510(k) regulatory clearance for a suite of devices designed to access and treat stenosed (narrowed) arteries from the thigh to the foot via radial (wrist) access. Our Sublime radial access platform provides a unique combination of length, profile and deliverability, allowing physicians to access and treat lesions previously inaccessible via radial access. Commercial sales of the Sublime guide sheath and RX PTA dilatation catheter devices began in fiscal 2022.

Sublime guide sheath provides the conduit for peripheral intervention with an access point at the wrist that enables treatment all the way to the pedal loop of the foot.
Sublime .014 RX PTA dilatation catheter treats lesions in peripheral arteries below the knee all the way to the patient’s foot and around the pedal loop.
Sublime .018 RX PTA dilatation catheter treats lesions in peripheral arteries above and below the knee.
Sublime microcatheters (.014, .018 and .035) facilitate guidewire placement for difficult to access and treat arterial lesions above and below the knee using radial, femoral, or alternate access sites. Limited market evaluations of our Sublime microcatheters

21


 

began in the third quarter of fiscal 2023. In the third quarter of fiscal 2024, we completed limited market evaluations for the Sublime microcatheter, and the product was commercially launched.

Performance Coatings – Preside™ Hydrophilic Coatings

In October 2023, we announced the commercial launch of our most advanced hydrophilic medical device coating technology, Preside hydrophilic coatings. Preside hydrophilic coatings complement our existing Serene™ hydrophilic coatings by providing customers with a unique low-friction and low-particulate generation coating to further enhance distal access for neuro-vascular applications, as well as improved crossing for challenging coronary lesions or chronic total occlusions. Preside hydrophilic coatings are specifically formulated to meet the challenge of achieving the right balance of enhanced lubricity (reduction in friction) and excellent coating durability (resulting in low particulates) for the next-generation of neurovascular, coronary and peripheral vascular devices. Our Preside and Serene hydrophilic coatings both allow customers to leverage their existing coating process to apply these innovative surface treatments.

For more information regarding our vascular intervention medical devices and performance coatings, see Part I, Item 1 of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024.

Results of Operations

Three Months Ended December 31, 2024 and 2023

Revenue. Revenue in the first quarter of fiscal 2025 was $29.9 million, a $0.6 million or 2% decrease compared to the prior-year quarter. The following is a summary of revenue streams of each reportable segment.

 

Three Months Ended December 31,

(Dollars in thousands)

2024

 

 

2023

 

 

Increase/(Decrease)

Medical Device

 

 

 

 

 

 

 

 

 

 

 

Product sales

$

10,116

 

 

$

11,950

 

 

$

(1,834

)

 

(15

)

%

Royalties & license fees – performance coatings

 

9,383

 

 

 

8,208

 

 

 

1,175

 

 

14

 

%

License fees – SurVeil DCB

 

1,251

 

 

 

971

 

 

 

280

 

 

29

 

%

R&D and other

 

2,531

 

 

 

2,416

 

 

 

115

 

 

5

 

%

Medical Device Revenue

 

23,281

 

 

 

23,545

 

 

 

(264

)

 

(1

)

%

In Vitro Diagnostics

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

6,432

 

 

 

6,877

 

 

 

(445

)

 

(6

)

%

R&D and other

 

209

 

 

 

130

 

 

 

79

 

 

61

 

%

In Vitro Diagnostics Revenue

 

6,641

 

 

 

7,007

 

 

 

(366

)

 

(5

)

%

Total Revenue

$

29,922

 

 

$

30,552

 

 

$

(630

)

 

(2

)

%

Medical Device. Revenue in our Medical Device segment was $23.3 million in the first quarter of fiscal 2025, a 1% decrease from $23.5 million in the prior-year quarter.

Medical Device product sales decreased 15% to $10.1 million in the first quarter of fiscal 2025, compared to $12.0 million in the prior-year quarter. Product sales decreased driven primarily by a decline in SurVeil commercial revenue as the prior year quarter benefited from the initial stocking order shipments of the SurVeil DCB to Abbott, the Company’s exclusive distribution partner for the product, partially offset by continued growth of the Pounce thrombectomy device platform.

Based on forecasts that we have received from Abbott for purchases of SurVeil DCB products, we expect product revenue for our SurVeil DCB products to decline by approximately $6.0 million in fiscal 2025 from their fiscal 2024 level. We do not expect any increases in sales from our Pounce thrombectomy device platform to fully offset that decrease.

Performance coating royalties and license fee revenue increased 14% to $9.4 million in the first quarter of fiscal 2025, compared to $8.2 million in the prior-year quarter. The year-over-year growth in performance coating royalties and license fee revenue was primarily driven by continued growth in customer utilization of our Serene™ hydrophilic coating.
SurVeil DCB license fee revenue under the Abbott Agreement was $1.3 million in the first quarter of fiscal 2025 compared to $1.0 million in the first quarter of fiscal 2024.

We anticipate completion of the TRANSCEND pivotal clinical trial in the second quarter of fiscal 2025. Consequently, we expect SurVeil DCB license fee revenue to decline by $3.6 million in fiscal 2025, compared to fiscal 2024, with no further recognition of SurVeil DCB license fee revenue subsequent to March 31, 2025.

22


 

Medical Device research and development (“R&D”) and other revenue increased to $2.5 million in the first quarter of fiscal 2025, compared to $2.4 million in the prior-year quarter, primarily driven by increased customer development programs.

In Vitro Diagnostics. Revenue in our In Vitro Diagnostics (“IVD”) segment was $6.6 million in the first quarter of fiscal 2025, a 5% decrease from $7.0 million in the prior-year quarter.

IVD product sales decreased 6% to $6.4 million in the first quarter of fiscal 2025, compared to $6.9 million in the prior-year quarter, primarily driven by unfavorable order timing for distributed antigen and diagnostic test chemical components.
IVD R&D and other revenue of $0.2 million in the first quarter of fiscal 2025 increased slightly compared to $0.1 million in the prior-year quarter, primarily driven by customer development projects.

Operating Costs and Expenses. Product sales, product costs, product gross profit, product gross margin, and operating costs were as follows:

 

Three Months Ended December 31,

(Dollars in thousands)

2024

 

2023

 

Increase/(Decrease)

Product sales

$

16,548

 

 

 

$

18,827

 

 

 

$

(2,279

)

 

(12

)

%

Product costs

 

7,425

 

 

 

 

8,803

 

 

 

 

(1,378

)

 

(16

)

%

Product gross profit (1)

 

9,123

 

 

 

 

10,024

 

 

 

 

(901

)

 

(9

)

%

% Product gross margin (2)

 

55.1

 

%

 

 

53.2

 

%

 

 

1.9

 

ppt

R&D expense

 

8,941

 

 

 

 

8,664

 

 

 

 

277

 

 

3

 

%

% Total revenue

 

30

 

%

 

 

28

 

%

 

 

 

 

 

 

SG&A expense

 

15,174

 

 

 

 

12,537

 

 

 

 

2,637

 

 

21

 

%

% Total revenue

 

51

 

%

 

 

41

 

%

 

 

 

 

 

 

Acquired intangible asset amortization

 

863

 

 

 

 

870

 

 

 

 

(7

)

 

(1

)

%

(1)
Product gross profit is defined as product sales less related product costs.
(2)
Product gross margin is defined as product gross profit as a percentage of product sales.

Product Gross Profit and Product Gross Margins. Product gross profit decreased $0.9 million, or 9%, in the first quarter of fiscal 2025, compared to the prior-year quarter. Product gross margins were 55.1% and 53.2% in the first quarter of fiscal 2025 and fiscal 2024, respectively. The year-over-year increase in product gross margins was primarily driven by favorable product mix of higher margin products partially offset by production inefficiencies, including the expiration of inventory related to our vascular intervention medical devices.

 

For the remainder of fiscal 2025, we expect product gross profit and product gross margin to decline, compared to their fiscal 2024 levels, primarily due to the expected decline in fiscal 2025 SurVeil DCB product revenue resulting in under-absorption and production inefficiencies associated with below-scale production, including potential expiration of inventory. We do not expect any increases in product gross profit from our Pounce thrombectomy device platform to fully offset that decrease.

R&D Expense. R&D expense increased 3%, or $0.3 million, in the first quarter of fiscal 2025 to $8.9 million, compared to $8.7 million in the prior-year quarter. R&D expense as a percentage of revenue was 30% and 28% in the first quarter of fiscal 2025 and 2024, respectively. For the first quarter of fiscal 2025, the year-over-year increase in R&D expense was primarily driven by higher compensation expenses to support our continued investment in medical devices, including our Pounce thrombectomy and Sublime radial access product platforms.

Selling, General and Administrative (“SG&A”) Expense. SG&A expense increased 21%, or $2.6 million, in the first quarter of fiscal 2025, compared to the prior-year quarter. SG&A expense as a percentage of revenue was 51% and 41% in the first quarter of fiscal 2025 and 2024, respectively. The year-over-year increase in SG&A expense in the first quarter of fiscal 2025 was primarily driven by $2.3 million in merger-related charges.

Acquired Intangible Asset Amortization. We have previously acquired certain intangible assets through business combinations, which are amortized over periods ranging from seven to 14 years.

23


 

Other Expense. Major classifications of other expense were as follows:

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Interest expense, net

$

(882

)

 

$

(896

)

Foreign exchange gain (loss)

 

32

 

 

 

(45

)

Investment income, net

 

387

 

 

 

539

 

Other expense, net

$

(463

)

 

$

(402

)

Interest expense, net in the first quarter of fiscal 2025 was relatively consistent with the same prior-year period. Refer to “Liquidity and Capital Resources” for further discussion of financing arrangements and expectations for fiscal 2025 interest expense. Foreign currency exchange gains (losses) result primarily from the impact of U.S. dollar to Euro exchange rate fluctuations on certain intercompany transactions and balances. Investment income, net decreased in the first quarter of fiscal 2025, compared to the same prior-year period, due to decreased investments in available-for-sale securities and lower interest rates.

Income Taxes. (Loss) income before income taxes, income tax expense and our effective tax rate were as follows:

 

Three Months Ended December 31,

(Dollars in thousands)

2024

 

2023

(Loss) income before income taxes

$

(2,944

)

 

 

$

(724

)

 

Income tax expense

 

(707

)

 

 

 

(62

)

 

Effective tax rate

 

(24

)

%

 

 

(9

)

%

Several factors impacted income taxes and our effective tax rate:

Beginning in our fiscal 2023, certain R&D costs are required to be capitalized and amortized over a five-year period under the Tax Cuts and Jobs Act enacted in December 2017. This change impacts the expected U.S. federal and state income tax expense and cash taxes paid and to be paid for our fiscal 2025 and fiscal 2024.
Since September 30, 2022, we have maintained a full valuation allowance against U.S. net deferred tax assets. As a result of the full valuation allowance, we are no longer recording a tax benefit associated with U.S. pre-tax losses and incremental deferred tax assets. A valuation allowance is required to be recognized against deferred tax assets if, based on the available evidence, it is more likely than not (defined as a likelihood of more than 50%) that all or a portion of such assets will not be realized. The relevant guidance weighs available evidence such as historical cumulative taxable losses more heavily than future profitability. The valuation allowance has no impact on the availability of U.S. net deferred tax assets to offset future tax liabilities.
Recurring items cause our effective tax rate to differ from the U.S. federal statutory rate of 21%, including foreign-derived intangible income (“FDII”) deductions in the U.S., U.S. federal and Irish R&D credits, Irish and U.S. state tax rates, excess tax benefits associated with stock-based compensation, and non-deductible merger-related charges.

Segment Operating Results

Operating results for each of our reportable segments were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

 

$ Change

 

Operating (loss) income:

 

 

 

 

 

 

 

 

Medical Device

$

161

 

 

$

(224

)

 

$

385

 

In Vitro Diagnostics

 

2,922

 

 

 

3,124

 

 

 

(202

)

Total segment operating income

 

3,083

 

 

 

2,900

 

 

 

183

 

Corporate

 

(5,564

)

 

 

(3,222

)

 

 

(2,342

)

Total operating (loss) income

$

(2,481

)

 

$

(322

)

 

$

(2,159

)

Medical Device. Our Medical Device business reported operating income of $0.2 million in the first quarter of fiscal 2025, compared to an operating loss of $(0.2) million in the prior-year quarter, representing 1% and (1)% of revenue, respectively.

Performance coating royalties and license fee revenue increased 14% to $9.4 million in the first quarter of fiscal 2025, compared to $8.2 million in the prior-year quarter.

24


 

Medical Device operating expenses, excluding product costs, increased $0.4 million year-over-year in the first quarter of fiscal 2025.

R&D expenditures in our Medical Device segment increased $0.1 million year-over-year in the first quarter of fiscal 2025 primarily driven by higher compensation expenses to support our continued investment in medical devices, including our Pounce thrombectomy and Sublime radial access product platforms.

SG&A expense in our Medical Device segment increased $0.3 million in the first quarter of fiscal 2025, compared to the prior-year quarter, primarily driven by higher compensation expenses.

Medical Device product gross profit decreased $0.8 million in the first quarter of fiscal 2025 , compared to the prior-year quarter, primarily driven by a decline in SurVeil commercial revenue as the year-ago-period benefited from the initial stocking order shipments of the SurVeil DCB to Abbott, the Company’s exclusive distribution partner for the product, offset by continued growth of the Pounce thrombectomy device platform. Medical Device product gross margins were 49.3% and 48.6% in the first quarter of fiscal 2025 and 2024, respectively.

In Vitro Diagnostics. Our In Vitro Diagnostics business reported operating income of $2.9 million and $3.1 million in the first quarter of fiscal 2025 and 2024, respectively, representing 44% and 45% of revenue, respectively.

IVD product gross profit decreased $0.1 million in the first quarter of fiscal 2025, compared to the prior-year quarter, primarily driven by unfavorable order timing for distributed antigen and diagnostic test chemical components. IVD product gross margins were 64.3% and 61.4% in the first quarter of fiscal 2025 and 2024, respectively. The gross margins increased primarily due to favorable product mix.

Corporate. The Corporate category includes expenses for administrative corporate functions, such as executive management, corporate accounting, information technology, legal, human resources and Board of Directors related fees and expenses, which we do not fully allocate to the Medical Device and IVD segments. Corporate also includes expenses, such as litigation and merger-and-acquisition-related costs, which are not specific to a segment and thus not allocated to our reportable segments. The unallocated Corporate operating loss was $(5.6) million and $(3.2) million in the first quarter of fiscal 2025 and 2024, respectively. The year-over-year increase in Corporate operating loss in the first quarter of fiscal 2025 was primarily driven by $2.3 million in Merger-related charges reported in SG&A expense.

Cash Flow Operating Results

The following is a summary of cash flow results:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Cash (used in) provided by:

 

 

 

 

 

Operating activities

$

(7,894

)

 

$

(8,792

)

Investing activities

 

3,698

 

 

 

(8,470

)

Financing activities

 

(1,203

)

 

 

(1,049

)

Effect of exchange rate changes on cash and cash equivalents

 

(571

)

 

 

247

 

Net change in cash and cash equivalents

$

(5,970

)

 

$

(18,064

)

Operating Activities. Cash used in operating activities was $(7.9) million in the first three months of fiscal 2025, compared to $(8.8) million in the same prior-year period. Significant changes in operating assets and liabilities affecting cash flows during these periods included:

Cash provided in accounts receivable and contract assets was $0.4 million in the first three months of fiscal 2025, compared to cash used of $(3.4) million in the same prior-year period. The year-over-year decrease in cash used was primarily driven by a decline in Medical Device product sales, from the initial stocking order shipments of the SurVeil DCB to Abbott. as well as a decline in IVD product sales, primarily driven by unfavorable order timing for distributed antigen and diagnostic test chemical components.
Cash used in deferred revenue was $(1.4) million in the first three months of fiscal 2025, compared to cash used of $(1.1) million in the same prior-year period, primarily related to the recognition of SurVeil DCB license fees.
Cash used in accrued liabilities was $(7.4) million in the first three months of fiscal 2025, compared to cash used of $(7.1) million in the same prior-year period, primarily related to the Company annual incentive plan.

25


 

In addition, income taxes affected the change in operating assets and liabilities. In the first three months of fiscal 2025, the change in operating assets and liabilities included cash provided by income taxes of $0.7 million.

Investing Activities. Cash (used in) provided by investing activities totaled $3.7 million in the first three months of fiscal 2025, compared to cash used of $(8.5) million in the same prior-year period.

Net purchases and maturities of available-for-sale investments were a source (use) of cash totaling $4.0 million and $(7.8) million in the first three months of fiscal 2025 and 2024, respectively.
We invested $0.3 million and $0.7 million in property and equipment in the first three months of fiscal 2025 and 2024, respectively.

Financing Activities. Cash (used in) provided by financing activities totaled $(1.2) million and $(1.0) million in the first three months of fiscal 2025 and 2024, respectively.

In the first three months of fiscal 2025 and 2024, we paid $1.3 million and $1.0 million, respectively, to purchase common stock to pay employee taxes resulting from the vesting of stock awards and the exercise of stock options.
In the first three months of fiscal 2025 and 2024, we generated $0.1 million and $0.0 million, respectively, from the sale of common stock related to our stock-based compensation plans.

Liquidity and Capital Resources

As of December 31, 2024, working capital totaled $58.7 million, a decrease of $2.1 million from $60.8 million as of September 30, 2024. We define working capital as current assets minus current liabilities. Cash and cash equivalents and available-for-sale investments totaled $30.1 million as of December 31, 2024, a decrease of $10.0 million from $40.1 million as of September 30, 2024.

The Company proactively manages its access to capital to support liquidity and continued growth. On October 14, 2022, Surmodics entered into a new, five-year secured credit agreement with MidCap, which consisted of up to $100 million in term loans ($25 million of which was at the sole discretion of MidCap and $50 million of which was an additional loan commitment that expired undrawn by the Company on December 31, 2024) and a $25 million revolving credit facility. At close, the Company drew $25 million on the term loan and $5 million on the revolving credit facility. These proceeds were partially used to retire the Company’s then existing $25 million revolving credit facility with Bridgewater Bank, of which $10 million was outstanding. Upon closing in October 2022, the Company’s cash balance increased by $19.3 million. In fiscal 2025, the Company expects total interest expense under the credit agreement with MidCap to be approximately $3.5 million.

Revolving Credit Facility. Surmodics has access to a revolving credit facility, which provides for maximum availability of $25 million, subject to a borrowing base. As of December 31, 2024, the outstanding balance on the revolving credit facility was $5 million. As of December 31, 2024, additional, incremental availability on the revolving credit facility was approximately $14.0 million, based on borrowing base eligibility requirements consisting primarily of the Company’s inventory, accounts receivable and contract asset balances. The revolving credit facility has an annual interest rate equal to 3.00% plus the greater of Term SOFR (as defined in the credit agreement) or 1.50%, and has a maturity date of October 1, 2027.
Term Loan. As of December 31, 2024, the outstanding principal on the term loan was $25 million. The credit agreement with MidCap calls for interest-only payments on the term loan over the first four years, which can be extended to five years if certain criteria are met. The Company has entered into an interest rate swap arrangement with Wells Fargo Bank, N.A., whereby the $25 million borrowing on the term loan’s variable base rate was fixed at 10.205% per annum for the five-year loan term. The term loan has a maturity date of October 1, 2027.

As of December 31, 2024, the Company’s shelf registration statement with the SEC allows the Company to offer potentially up to $200 million in debt securities, common stock, preferred stock, warrants, and other securities or any such combination of such securities in amounts, at prices, and on terms announced if and when the securities are ever offered. This shelf registration statement expires in May 2026.

In fiscal 2025, we anticipate SG&A and R&D expenses will continue to be significant, primarily related to medical device sales and product development, including continued investment in our Pounce and Sublime product platforms. We believe that our existing cash and cash equivalents, which totaled $30.1 million as of December 31, 2024, together with cash flow from operations and our revolving credit facility, will provide liquidity sufficient to meet our cash needs and fund our operations and planned capital expenditures for fiscal 2025. There can be no assurance, however, that our business will continue to generate cash flows at historic levels.

26


 

Beyond fiscal 2025, our cash requirements will depend extensively on the timing of market introduction and extent of market acceptance of products in our medical device product portfolio, including the SurVeil DCB distributed by Abbott, our exclusive distribution partner for the product. Our long-term cash requirements also will be significantly impacted by the level of our investment in commercialization of our vascular intervention device products and whether we make future corporate transactions. We cannot accurately predict our long-term cash requirements at this time. We may seek additional sources of liquidity and capital resources, including through borrowing, debt or equity financing or corporate transactions to generate cashflow. There can be no assurance that such transactions will be available to us on favorable terms, if at all.

Customer Concentrations

We have agreements with a diverse base of customers and certain customers have multiple products using our technology. Abbott and Medtronic are our largest customers, comprising 16% and 12%, respectively, of our consolidated revenue for fiscal 2024. Abbott and Medtronic each comprised approximately 12%, of our consolidated revenue for the three months ended December 31, 2024.

Critical Accounting Policies and Significant Estimates

Critical accounting policies are those policies that require the application of management’s most challenging subjective or complex judgment, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. Critical accounting policies involve judgments and uncertainties that are sufficiently likely to result in materially different results under different assumptions and conditions. For the three months ended December 31, 2024, there were no significant changes in our critical accounting policies. For a detailed description of our other critical accounting policies and significant estimates, see Management’s Discussion and Analysis of Financial Condition and Results of Operations under Item 7 in our Annual Report on Form 10-K for the fiscal year ended September 30, 2024.

Forward-looking Statements

This Quarterly Report on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 2, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, our strategies for growth and profitability; statements about the Merger and its effects; the expected duration of limited market evaluations and product commercialization following limited market evaluations; the promising signals of potential performance of our Sundance DCB; plans to evaluate our strategy for further clinical investment in the Sundance DCB; expected product revenue from SurVeil DCB products; any increase in Pounce thrombectomy platform product sales revenues or gross profits; future gross profits and gross margins; future revenue growth, our longer-term valuation-creation strategy, and our future potential; information about our product pipeline; future gross margins, operating expenses, and capital expenditures; the potential impact of a shift in revenue mix towards sales of medical devices; estimated future amortization expense; expectations regarding operating expenses and their impact on our cash flows; the period over which unrecognized compensation costs is expected to be recognized; the expected completion timeframe for the TRANSCEND clinical trial; the period over which deferred revenue related to the Abbott Agreement is expected to be recognized; anticipated cash requirements; the intended use of remaining proceeds of our borrowing under the MidCap Credit Agreement; future cash flows and sources of funding, and their ability together with existing cash, and cash equivalents, to provide liquidity sufficient to meet our cash needs and fund our operations and planned capital expenditures for fiscal 2025; statements regarding cash requirements beyond fiscal 2025; expectations regarding capital available under our secured revolving credit facility; expectations regarding the maturity of debt; future impacts of our interest rate swap transactions; our expected interest expense in fiscal 2025 under the MidCap Credit Agreement; the impact of potential lawsuits or claims; the potential impact of interest rate fluctuations on our results of operations and cash flows; the impact of potential change in raw material prices, sources of raw materials and our ability to manufacture raw materials ourselves; the potential impact on the Company of currency fluctuations; future income tax (expense) benefit; expected income tax expense and cash taxes to be paid; the likelihood that we will realize the benefits of our deferred tax assets; and the impact of the adoption of new accounting pronouncements. Without limiting the foregoing, words or phrases such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “project,” “will” and similar terminology, generally identify forward-looking statements. Forward-looking statements may also represent challenging goals for us. These statements, which represent our expectations or beliefs concerning various future events, are based on current expectations that involve a number of risks and uncertainties that could cause actual results to differ materially from those of such forward-looking statements. We caution that undue reliance should not be placed on such forward-looking statements, which speak only as of the date made. Some of the factors which could cause results to differ from those expressed in any forward-looking statement are set forth under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q and in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024. We disclaim any intent or obligation to update publicly these forward-looking statements, whether because of new information, future events or otherwise.

27


 

Although it is not possible to create a comprehensive list of all factors that may cause actual results to differ from our forward-looking statements, such factors include, among others:

1.
risks related to the Merger, including (1) risks related to the consummation of the Merger, including the risks that (a) the Merger may not be consummated within the anticipated time period, or at all, (b) the parties may fail to secure the termination or expiration of any waiting period applicable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), (c) other conditions to the consummation of the Merger under the Merger Agreement may not be satisfied, including the absence of any injunction or other legal restraint or prohibition that would prevent or prohibit the consummation of the Merger, such as the voluntary agreement being in effect with the U.S. Federal Trade Commission (d) all or part of Parent’s financing may not become available, and (e) the significant limitations on remedies contained in the Merger Agreement may limit or entirely prevent the Company from specifically enforcing Parent’s obligations under the Merger Agreement or recovering damages for any breach by Parent; (2) the effects that any termination of the Merger Agreement may have on the Company or its business, including the risks that (a) the Company’s stock price may decline significantly if the Merger is not completed, (b) the Merger Agreement may be terminated in circumstances requiring the Company to pay Parent a termination fee of $20,380,000, or (c) the circumstances of the termination, including the possible imposition of a 12-month tail period during which the termination fee could be payable upon certain subsequent transactions, may have a chilling effect on alternatives to the Merger; (3) the effects that the announcement or pendency of the Merger may have on the Company and its business, including the risks that as a result (a) the Company’s business, operating results or stock price may suffer, (b) the Company’s current plans and operations may be disrupted, (c) the Company’s ability to retain or recruit key employees may be adversely affected, (d) the Company’s business relationships (including, customers, franchisees and suppliers) may be adversely affected, or (e) the Company’s management’s or employees’ attention may be diverted from other important matters; (4) the effect of limitations that the Merger Agreement places on the Company’s ability to operate its business, return capital to shareholders or engage in alternative transactions; (5) the nature, cost and outcome of pending and future litigation and other legal proceedings, including any such proceedings related to the Merger and instituted against the Company and others; (6) the risk that the Merger and related transactions may involve unexpected costs, liabilities or delays; and (7) other risks, including our ability to sign new license agreements, conduct clinical evaluations, and bring new products to market;
2.
ongoing operating losses, interest expense, and failure to generate cash flows from operations, which could impact expected expenditures and investments in growth initiatives;
3.
our reliance on a small number of significant customers, including our largest customers, Abbott and Medtronic, which causes our financial results and stock price to be subject to factors affecting those significant customers and their products, the timing of market introduction of their or competing products, product safety or efficacy concerns and intellectual property litigation impacting such customers, which could adversely affect our growth strategy and the royalties revenue we derive;
4.
our ability to successfully manufacture at commercial volumes our SurVeil DCB products;
5.
our ability to successfully develop, obtain and maintain regulatory approval for, commercialize, and manufacture at commercial volumes our other DCB products;
6.
general economic conditions that are beyond our control, such as the impacts of recessions, inflation, rising interest rates, customer mergers and acquisitions, business investment, changes in consumer confidence, and medical epidemics or pandemics such as the COVID-19 pandemic, which negatively impacted our business and results of operations;
7.
our ability to successfully and profitably commercialize our vascular intervention products, including our Pounce Venous Thrombectomy System, through our direct salesforce, or otherwise;
8.
our ability to comply with the terms of our secured revolving credit facility and secured term loan facilities;
9.
the difficulties and uncertainties associated with the lengthy and costly new product development and foreign and domestic regulatory approval processes, such as delays, difficulties or failures in achieving acceptable clinical results or obtaining foreign or FDA marketing clearances or approvals, which may result in lost market opportunities, failure to bring new products to market or postpone or preclude product commercialization by licensees or ourselves;
10.
whether operating expenses that we incur related to the development and commercialization of new technologies and products are effective;

28


 

11.
our ability to successfully perform product development activities, the related research and development expense impact, and governmental and regulatory compliance activities, with which we do not have extensive experience;
12.
impairment of goodwill and intangible assets or the establishment of reserves against other assets on our balance sheets; and
13.
other factors described under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q and in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024, which you are encouraged to read carefully.

Many of these factors are outside our control and knowledge and could result in increased volatility in period-to-period results. Investors are advised not to place undue reliance upon our forward-looking statements and to consult any further disclosures by us on this subject in our filings with the Securities and Exchange Commission.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our investment policy requires investments with high credit quality issuers and limits the amount of credit exposure to any one issuer. Our investments consist principally of interest-bearing corporate debt securities with varying maturity dates, which generally are less than one year. Because of the credit criteria of our investment policies, the primary market risk associated with these investments is interest rate risk. As of December 31, 2024, we did not hold any available-for-sale debt securities. Therefore, interest rate fluctuations relating to investments would have an insignificant impact on our results of operations or cash flows. Our policy also allows the Company to hold a substantial portion of funds in cash and cash equivalents, which are defined as financial instruments with original maturities of three months or less and may include money market instruments, certificates of deposit, repurchase agreements and commercial paper instruments.

Loans under the Midcap Credit Agreement bear interest at floating rates tied to Term SOFR. As a result, changes in Term SOFR can affect our results of operations and cash flows to the extent we do not have effective interest rate swap arrangements in place. On October 14, 2022, we entered into a five-year interest rate swap transaction with Wells Fargo Bank, N.A. with respect to $25.0 million of notional value of the term loans funded under the MidCap Credit Agreement. The interest rate swap transaction fixes at 4.455% the one-month Term SOFR portion of interest rate under the $25.0 million term loan such that the interest rate on $25.0 million of the term loan will be 10.205% through its maturity. We have no other swap arrangements in place for any other loans under the Midcap Credit Agreement.

Management believes that a reasonable change in raw material prices would not have a material impact on future earnings or cash flows because the Company’s inventory exposure is not material.

We are exposed to increasing Euro currency risk with respect to our manufacturing operations in Ireland. In addition, the contractual transfer price paid by Abbott for commercial units of our SurVeil DCB product is denominated in Euros. In a period where the U.S. dollar is strengthening or weakening relative to the Euro, our revenue and expenses denominated in Euro currency are translated into U.S. dollars at a lower or higher value than they would be in an otherwise constant currency exchange rate environment. All sales transactions are denominated in U.S. dollars or Euros. We generate royalties revenue from the sale of customer products in foreign jurisdictions. Royalties generated in foreign jurisdictions by customers are converted and paid in U.S. dollars per contractual terms. Substantially all of our purchasing transactions are denominated in U.S. dollars or Euros. To date, we have not entered into any foreign currency forward exchange contracts or other derivative financial instruments to hedge the effects of adverse fluctuations in foreign currency exchange rates.

29


 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The Company maintains disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The Company’s management, under the supervision and with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, referred to collectively herein as the “Certifying Officers,” carried out an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of December 31, 2024. Based on that evaluation, the Company’s Certifying Officers concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) were effective to ensure that information required to be disclosed by the Company in reports that it files under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the Securities and Exchange Commission rules and forms, and to ensure that information required to be disclosed by the Company in the reports the Company files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its Certifying Officers, as appropriate, to allow timely decisions regarding required disclosures.

Changes in Internal Controls over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) during the three months ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

30


 

PART II — OTHER INFORMATION

From time to time, the Company has been involved in various legal actions involving its operations, products and technologies, including intellectual property and employment disputes.

Item 1A. Risk Factors

The information presented below updates, and should be read in conjunction with, the risk factors identified in our Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the Securities and Exchange Commission on November 20, 2024, under Part I, Item 1A, “Risk Factors.” Such risks could affect our financial performance and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this Quarterly Report on Form 10-Q. Except as presented below, there were no other significant changes in our risk factors during the quarter ended December 31, 2024.

The completion of the Merger is subject to a number of conditions, many of which are largely outside of the parties’ control, and, if these conditions are not satisfied or waived on a timely basis, the Merger Agreement may be terminated and the Merger may not be completed.

The Merger is subject to various closing conditions that remain open, including:

(1) the expiration or termination of the waiting period applicable to the consummation of the Merger under the HSR Act and no voluntary agreement being in effect with either the Federal Trade Commission or Antitrust Division of the Department of Justice not to consummate the transaction for any period of time;

(2) the absence of any judgment, ruling, order, writ, injunction or decree of any governmental authority, nor any statute, code, decree, law, healthcare law, act, ordinance, rule, regulation or order of any governmental authority or other legal restraint or prohibition, that is in effect that would make the Merger illegal or otherwise prevent or prohibit its consummation;

(3) subject to specific standards, the accuracy of the representations and warranties of the other party or parties;

(4) the performance or compliance in all material respects by the other party or parties of such party’s or parties’ covenants, obligations, and agreements under the Merger Agreement;

(5) with respect to Parent’s and Merger Sub’s obligations to consummate the merger, the absence of a material adverse effect (as defined in the Merger Agreement) and the absence of any changes having occurred that would reasonably be expected to have, individually or in the aggregate, a material adverse effect;

(6) our having delivered to Parent a certificate, dated as of the closing date and signed by one of our executive officers, certifying to the satisfaction of the foregoing conditions; and

(7) Parent and Merger Sub having delivered to us a certificate, dated as of the closing date and signed by an executive officer, certifying to the satisfaction of the foregoing conditions.

The failure to satisfy all of the required conditions could delay the completion of the Merger by a significant period of time or prevent it from closing. Any delay in completing the Merger could cause the parties to not realize some or all of the benefits that are expected to be achieved if the Merger is successfully completed within the expected timeframe. There can be no assurance that the conditions to closing of the Merger will be satisfied or waived or that the Merger will be completed within the expected timeframe, or at all.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

The following table presents the information with respect to purchases made by or on behalf of Surmodics, Inc. or any “affiliated purchaser” (as defined in Rule 10b-18(a)(3) under the Securities Exchange Act of 1934), of our common stock during the three months ended December 31, 2024.

31


 

 

 

Total Number of
Shares Purchased (1)

 

 

Average Price Paid
Per Share

 

 

Total Number of Shares Purchased as Part of Publicly Announced Programs

 

 

Maximum Dollar Value of Shares that May Yet Be Purchased Under the Programs

 

Period:

 

 

 

 

 

 

 

 

 

 

 

 

October 1 – 31, 2024

 

 

63

 

 

$

37.59

 

 

 

 

 

$

25,300,000

 

November 1 – 30, 2024

 

 

20,505

 

 

 

39.45

 

 

 

 

 

 

25,300,000

 

December 1 – 31, 2024

 

 

12,448

 

 

 

39.91

 

 

 

 

 

 

25,300,000

 

Total

 

 

33,016

 

 

 

39.62

 

 

 

 

 

 

 

(1)
All shares reported were delivered by employees in connection with the satisfaction of tax withholding obligations related to the vesting of shares of restricted stock.

The Company has an aggregate of $25.3 million available for future common stock purchases under the current authorizations. The MidCap Credit Agreement restricts our ability to repurchase our common stock.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information

During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted, modified or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).

32


 

 

Item 6. Exhibits

EXHIBIT INDEX

Exhibit

 

Description

 

 

 

2.1

 

Stock Purchase Agreement, dated January 8, 2016, among Surmodics, Inc. and the shareholders of NorMedix, Inc. and Gregg Sutton as Seller’s Agent — incorporated by reference to Exhibit 2.1 to the Company’s Form Current Report on Form 8-K filed on January 13, 2016.

 

 

 

2.2

 

Share Purchase Agreement by and among Surmodics, Inc., SurModics MD, LLC, and the shareholders of Vetex Medical Limited named therein dated as of July 2, 2021 — incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K dated July 2, 2021.

 

 

 

2.3

 

Put and Call Option Agreement by and among SurModics MD, LLC and the shareholders of Vetex Medical Limited named therein dated as of July 2, 2021 — incorporated by reference to Exhibit 2.2 to the Company’s Current Report on Form 8-K dated July 2, 2021.

 

 

 

2.4

 

Merger Agreement, dated as of May 28, 2024, by and among Surmodics, Inc., BCE Parent, LLC and BCE Merger Sub, Inc. — incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K dated May 28, 2024.

 

 

 

3.1

 

Restated Articles of Incorporation, as amended — incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q filed on July 29, 2016.

 

 

 

3.2

 

Restated Bylaws of Surmodics, Inc., as amended August 27, 2024 – incorporated by reference to Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed on July 31, 2024.

 

 

 

31.1*

 

Certification of Chief Executive Officer pursuant to 18 U.S.C. Sec. 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2*

 

Certification of Chief Financial Officer pursuant to 18 U.S.C. Sec. 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1*

 

Certification of Chief Executive Officer pursuant to 18 U.S.C. Sec. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.2*

 

Certification of Chief Financial Officer pursuant to 18 U.S.C. Sec. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101.INS*

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document.

 

 

 

101.SCH*

 

Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents.

 

 

 

104*

 

Cover page formatted as Inline XBRL and contained in Exhibit 101.

 

* Filed herewith

33


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

January 30, 2025

Surmodics, Inc.

 

 

 

 

By:

/s/ Timothy J. Arens

 

 

Timothy J. Arens

 

 

Senior Vice President of Finance and Chief Financial Officer

 

 

 

 

(duly authorized signatory and principal financial officer)

 

34


 

EXHIBIT 31.1

 

CERTIFICATION PURSUANT TO SECTION 302

OF THE SARBANES-OXLEY ACT OF 2002

 

I, Gary R. Maharaj, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of Surmodics, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: January 30, 2025

Signature:

/s/ Gary R. Maharaj

Gary R. Maharaj

President and

 

 

Chief Executive Officer

 

 


 

EXHIBIT 31.2

 

CERTIFICATION PURSUANT TO SECTION 302

OF THE SARBANES-OXLEY ACT OF 2002

 

I, Timothy J. Arens, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of Surmodics, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: January 30, 2025

Signature:

/s/ Timothy J. Arens

Timothy J. Arens

Senior Vice President of Finance and Chief Financial Officer

 

 


 

EXHIBIT 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Surmodics, Inc. (the “Company”) on Form 10-Q for the quarter ended December 31, 2024, as filed with the Securities and Exchange Commission (the “Report”), I, Gary R. Maharaj, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: January 30, 2025

Signature:

/s/ Gary R. Maharaj

Gary R. Maharaj

President and

 

 

Chief Executive Officer

 

 


 

EXHIBIT 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Surmodics, Inc. (the “Company”) on Form 10-Q for the quarter ended December 31, 2024, as filed with the Securities and Exchange Commission (the “Report”), I, Timothy J. Arens, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: January 30, 2025

Signature:

/s/ Timothy J. Arens

Timothy J. Arens

Senior Vice President of Finance and Chief Financial Officer

 

 

 

 

 


v3.24.4
Document and Entity Information - shares
3 Months Ended
Dec. 31, 2024
Jan. 27, 2025
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Dec. 31, 2024  
Document Fiscal Year Focus 2025  
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, $0.05 par value  
Entity File Number 0-23837  
Entity Incorporation, State or Country Code MN  
Entity Tax Identification Number 41-1356149  
Entity Address, Address Line One 9924 West 74th Street  
Entity Address, City or Town Eden Prairie  
Entity Address, State or Province MN  
Entity Address, Postal Zip Code 55344  
City Area Code 952  
Local Phone Number 500-7000  
Document Quarterly Report true  
Document Transition Report false  
Entity Common Stock, Shares Outstanding   14,295,998
v3.24.4
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Current Assets:    
Cash and cash equivalents $ 30,145 $ 36,115
Available-for-sale securities   3,997
Accounts receivable, net of allowances of $220 and $144 as of December 31, 2024 and September 30, 2024, respectively 12,559 13,292
Contract assets 9,879 9,872
Inventories 15,261 15,168
Prepaids and other 4,005 2,860
Total Current Assets 71,849 81,304
Property and equipment, net 23,805 24,956
Intangible assets, net 21,271 23,569
Goodwill 42,408 44,640
Other assets 4,407 4,093
Total Assets 163,740 178,562
Current Liabilities:    
Accounts payable 2,561 2,786
Accrued liabilities:    
Compensation 4,882 11,099
Accrued other 3,582 3,795
Deferred revenue 266 1,619
Income tax payable 1,894 1,244
Total Current Liabilities 13,185 20,543
Long-term debt, net 29,591 29,554
Deferred income taxes 1,595 1,785
Other long-term liabilities 7,600 7,783
Total Liabilities 51,971 59,665
Commitments and Contingencies (Note 11)
Stockholders’ Equity:    
Series A Preferred stock - $.05 par value, 450 shares authorized; no shares issued and outstanding
Common stock - $.05 par value, 45,000 shares authorized; 14,294 and 14,325 shares issued and outstanding as of December 31, 2024 and September 30, 2024, respectively 715 716
Additional paid-in capital 45,135 44,594
Accumulated other comprehensive loss (6,143) (2,126)
Retained earnings 72,062 75,713
Total Stockholders’ Equity 111,769 118,897
Total Liabilities and Stockholders’ Equity $ 163,740 $ 178,562
v3.24.4
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Statement of Financial Position [Abstract]    
Allowances (accounts receivable) $ 220 $ 144
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 14,294,000 14,325,000
Common stock, shares outstanding 14,294,000 14,325,000
v3.24.4
Condensed Consolidated Statements of Operations - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Revenue:    
Total revenue $ 29,922 $ 30,552
Operating costs and expenses:    
Cost, Product and Service [Extensible Enumeration] Product Sales [Member] Product Sales [Member]
Product costs $ 7,425 $ 8,803
Research and development 8,941 8,664
Selling, general and administrative 15,174 12,537
Acquired intangible asset amortization 863 870
Total operating costs and expenses 32,403 30,874
Operating (loss) income (2,481) (322)
Other expense, net:    
Interest expense, net (882) (896)
Foreign exchange gain (loss) 32 (45)
Investment income, net 387 539
Other expense, net (463) (402)
(Loss) income before income taxes (2,944) (724)
Income tax expense (707) (62)
Net loss $ (3,651) $ (786)
Basic net (loss) income per share $ (0.26) $ (0.06)
Diluted net (loss) income per share $ (0.26) $ (0.06)
Weighted average number of shares outstanding:    
Basic 14,231 14,102
Diluted 14,231 14,102
Product Sales [Member]    
Revenue:    
Total revenue $ 16,548 $ 18,827
Royalties and License Fees [Member]    
Revenue:    
Total revenue 10,634 9,179
Research, Development and Other [Member]    
Revenue:    
Total revenue $ 2,740 $ 2,546
v3.24.4
Condensed Consolidated Statements of Comprehensive (Loss) Income - USD ($)
$ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Statement of Comprehensive Income [Abstract]    
Net loss $ (3,651) $ (786)
Derivative instruments:    
Unrealized net gain (loss) 506 (620)
Net gain reclassified to earnings (29) (62)
Net changes related to available-for-sale securities, net of tax   (8)
Foreign currency translation adjustments (4,494) 2,797
Other comprehensive (loss) income (4,017) 2,107
Comprehensive (loss) income $ (7,668) $ 1,321
v3.24.4
Condensed Consolidated Statements of Stockholders' Equity - USD ($)
shares in Thousands, $ in Thousands
Total
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Other Comprehensive Loss [Member]
Retained Earnings [Member]
Beginning balance at Sep. 30, 2023 $ 119,910 $ 708 $ 36,706 $ (4,759) $ 87,255
Beginning balance, shares at Sep. 30, 2023   14,155      
Net Income (Loss) (786)       (786)
Other comprehensive income (loss), net of tax 2,107     2,107  
Issuance of common stock   $ 5 (5)    
Issuance of common stock ,shares   102      
Common stock options exercised, net 39   39    
Common stock options exercised, net, shares   7      
Purchase of common stock to pay employee taxes (1,088) $ (1) (1,087)    
Purchase of common stock to pay employee taxes ,shares   (29)      
Stock-based compensation 1,968   1,968    
Ending balance at Dec. 31, 2023 122,150 $ 712 37,621 (2,652) 86,469
Ending balance ,shares at Dec. 31, 2023   14,235      
Beginning balance at Sep. 30, 2024 118,897 $ 716 44,594 (2,126) 75,713
Beginning balance, shares at Sep. 30, 2024   14,325      
Net Income (Loss) (3,651)       (3,651)
Other comprehensive income (loss), net of tax (4,017)     (4,017)  
Issuance of common stock ,shares   (1)      
Common stock options exercised, net 105   105    
Common stock options exercised, net, shares   3      
Purchase of common stock to pay employee taxes (1,308) $ (1) (1,307)    
Purchase of common stock to pay employee taxes ,shares   (33)      
Stock-based compensation 1,743   1,743    
Ending balance at Dec. 31, 2024 $ 111,769 $ 715 $ 45,135 $ (6,143) $ 72,062
Ending balance ,shares at Dec. 31, 2024   14,294      
v3.24.4
Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Operating Activities:    
Net loss $ (3,651) $ (786)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:    
Depreciation and amortization 2,083 2,333
Stock-based compensation 1,743 1,968
Noncash lease expense 208 183
Amortization of debt issuance costs 76 76
Provision for credit losses 76 6
Deferred taxes (68) (97)
Other 5 (123)
Change in operating assets and liabilities:    
Accounts receivable and contract assets 435 (3,430)
Inventories (93) 401
Prepaids and other (515) (788)
Accounts payable (216) (428)
Accrued liabilities (7,362) (7,084)
Income taxes 738 99
Deferred revenue (1,353) (1,122)
Net cash (used in) provided by operating activities (7,894) (8,792)
Investing Activities:    
Purchases of property and equipment (302) (720)
Purchases of available-for-sale securities   (9,750)
Maturities of available-for-sale securities 4,000 2,000
Net cash (used in) provided by investing activities 3,698 (8,470)
Financing Activities:    
Issuance of common stock 105 39
Payments for taxes related to net share settlement of equity awards (1,308) (1,088)
Net cash (used in) provided by financing activities (1,203) (1,049)
Effect of exchange rate changes on cash and cash equivalents (571) 247
Net change in cash and cash equivalents (5,970) (18,064)
Cash and Cash Equivalents:    
Beginning of period 36,115 41,419
End of period 30,145 23,355
Supplemental Information:    
Cash paid for interest 785 779
Noncash investing and financing activities:    
Acquisition of property and equipment $ 141 43
Right-of-use assets obtained in exchange for operating lease liabilities   $ 845
v3.24.4
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Pay vs Performance Disclosure    
Net Income (Loss) $ (3,651) $ (786)
v3.24.4
Insider Trading Arrangements
3 Months Ended
Dec. 31, 2024
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
Rule 10b5-1 Arrangement Modified false
Non-Rule 10b5-1 Arrangement Modified false
v3.24.4
Organization
3 Months Ended
Dec. 31, 2024
Accounting Policies [Abstract]  
Organization

1. Organization

Description of Business

Surmodics, Inc. and subsidiaries (referred to as “Surmodics,” the “Company,” “we,” “us,” “our” and other like terms) is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic (“IVD”) immunoassay tests and microarrays. Surmodics develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. Our key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota.

On May 28, 2024, Surmodics entered into a Merger Agreement (the “Merger Agreement”) with BCE Parent, LLC, a Delaware limited liability company (“Parent”), and BCE Merger Sub, Inc., a Minnesota corporation and a wholly owned Subsidiary of Parent (“Merger Sub”), pursuant to which Surmodics will, subject to the terms and conditions thereof, be acquired by Parent for $43.00 per share in cash through the merger of Merger Sub with and into the Company, with the Company as the surviving corporation and a wholly owned subsidiary of Parent. See Note 13 Merger Agreement for additional information.

Basis of Presentation and Principles of Consolidation

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, 2024, and notes thereto included in our Annual Report on Form 10-K as filed with the SEC.

Use of Estimates

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 liabilities at the date of the condensed 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, 2024 are not necessarily indicative of the results that may be expected for the entire 2025 fiscal year.

New Accounting Pronouncements

Not Yet Adopted

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures. This guidance requires disclosure of incremental segment information on an annual and interim basis. This amendment is effective for our fiscal year ending September 30, 2025 and interim periods within our fiscal year ending September 30, 2026. We are currently assessing the impact of this guidance on our disclosures.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes: Improvements to Income Tax Disclosures. This guidance requires consistent categories and greater disaggregation of information in the rate reconciliation and disclosures of income taxes paid by jurisdiction. This amendment is effective for our fiscal year ending September 30, 2026 and interim periods within our fiscal year ending September 30, 2027. We are currently assessing the impact of this guidance on our disclosures.

No other new accounting pronouncement issued or effective during our fiscal year ending September 30, 2025, or is expected to have, a material impact on the Company’s condensed consolidated financial statements.

v3.24.4
Revenue
3 Months Ended
Dec. 31, 2024
Revenue from Contract with Customer [Abstract]  
Revenue

2. Revenue

The following table is a disaggregation of revenue within each reportable segment.

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Medical Device

 

 

Product sales

$

10,116

 

 

$

11,950

 

Royalties & license fees – performance coatings

 

9,383

 

 

 

8,208

 

License fees – SurVeil DCB

 

1,251

 

 

 

971

 

Research, development and other

 

2,531

 

 

 

2,416

 

Medical Device Revenue

 

23,281

 

 

 

23,545

 

In Vitro Diagnostics

 

 

 

 

 

Product sales

 

6,432

 

 

 

6,877

 

Research, development and other

 

209

 

 

 

130

 

In Vitro Diagnostics Revenue

 

6,641

 

 

 

7,007

 

Total Revenue

$

29,922

 

 

$

30,552

 

Contract assets totaled $10.7 million and $10.6 million as of December 31, 2024 and September 30, 2024, respectively, and was reported in contract assets, current and other assets, noncurrent (Note 5) on the condensed consolidated balance sheets. Fluctuations in the balance of contract assets result primarily from (i) fluctuations in the sales volume of performance coating royalties and license fees earned, but not collected, at each balance sheet date due to payment timing and contractual changes in the normal course of business; and (ii) starting in fiscal 2024, sales-based profit-sharing earned, but not collected, related to a collaborative arrangement (Note 3).

Deferred revenue totaled $0.3 million and $1.6 million as of December 31, 2024 and September 30, 2024, respectively, on the condensed consolidated balance sheets and was primarily related to a collaborative arrangement (Note 3). For the three months ended December 31, 2024 and 2023, the total amount of revenue recognized that was included in the respective beginning of fiscal year balances of deferred revenue on the condensed consolidated balance sheets totaled $1.3 million and $1.0 million, respectively.

v3.24.4
Collaborative Arrangement
3 Months Ended
Dec. 31, 2024
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”) with respect to one of the device products in our Medical Device reportable segment, the SurVeil™ drug-coated balloon (“DCB”) for treatment of the superficial femoral artery (the “Abbott Agreement”). In June 2023, the SurVeil DCB received U.S. Food and Drug Administration (“FDA”) premarket approval (“PMA”) and may now be marketed and sold in the U.S. by Abbott.

SurVeil DCB License Fees

Under the Abbott Agreement, Surmodics is responsible for conducting all necessary clinical trials, including completion of the ongoing, five-year TRANSCEND pivotal clinical trial of the SurVeil DCB. The Company has received payments totaling $87.8 million for achievement of clinical and regulatory milestones under the Abbott Agreement, which consisted of the following: (i) a $25 million upfront fee in fiscal 2018, (ii) a $10 million milestone payment in fiscal 2019, (iii) a $10.8 million milestone payment in fiscal 2020, (iv) a $15 million milestone payment in fiscal 2021, and (v) a $27 million milestone payment in the third quarter of fiscal 2023 upon receipt of PMA for the SurVeil DCB from the FDA. There are no remaining contingent or other milestone payments under the Abbott Agreement.

License fee revenue on milestone payments received under the Abbott Agreement is recognized using the cost-to-cost method based on total costs incurred to date relative to total expected costs for the TRANSCEND pivotal clinical trial, which is expected to be competed in fiscal 2025. See Note 2 Revenue for SurVeil DCB license fee revenue recognized in our Medical Device reportable segment.

As of December 31, 2024, deferred revenue on the condensed consolidated balance sheets included $0.3 million from upfront and milestone payments received under the Abbott Agreement. This represented the Company’s remaining performance obligations and is expected to be recognized as revenue in the second quarter of fiscal 2025 as services, principally the TRANSCEND clinical trial, are completed.

SurVeil DCB Product Sales

Under the Abbott Agreement, we supply commercial units of the SurVeil DCB to Abbott, and Abbott has exclusive worldwide distribution rights. During the first quarter of fiscal 2024, we commenced shipment of commercial units of the SurVeil DCB to Abbott. We recognize revenue from the sale of commercial units of the SurVeil DCB to Abbott at the time of shipment in product sales on the condensed consolidated statements of operations. The amount of SurVeil DCB product sales revenue recognized includes (i) the contractual transfer price per unit and (ii) an estimate of Surmodics’ share of net profits resulting from product sales by Abbott to third parties pursuant to the Abbott Agreement (“estimated SurVeil DCB profit-sharing”). On a quarterly basis, Abbott (i) reports to us its third-party sales of the SurVeil DCB the quarter after those sales occur, which may occur within two years following shipment based on the product’s current shelf life; and (ii) reports to us and pays the actual amount of profit-sharing. Estimated SurVeil DCB profit-sharing represents variable consideration and is recorded in contract assets, current and other assets, noncurrent on the condensed consolidated balance sheets. We estimate variable consideration as the most-likely amount to which we expect to be entitled, and we include estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue will not occur when the uncertainty associated with the variable consideration is resolved. Significant judgment is required in estimating the amount of variable consideration to recognize when assessing factors outside of Surmodics’ influence, such as limited availability of third-party information, expected duration of time until resolution, and limited relevant past experience.

v3.24.4
Fair Value Measurements
3 Months Ended
Dec. 31, 2024
Fair Value Disclosures [Abstract]  
Fair Value Measurements

4. Fair Value Measurements

Assets and liabilities measured at fair value on a recurring basis by level of the fair value hierarchy were as follows:

 

 

December 31, 2024

 

(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 (1)

$

 

 

$

23,228

 

 

$

 

 

$

23,228

 

Available-for-sale securities (1)

 

 

 

 

 

 

 

 

 

 

 

Total assets

$

 

 

$

23,228

 

 

$

 

 

$

23,228

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap (2)

 

 

 

 

196

 

 

 

 

 

 

196

 

Total liabilities

$

 

 

$

196

 

 

$

 

 

$

196

 

 

 

September 30, 2024

 

(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 (1)

$

 

 

$

29,334

 

 

$

 

 

$

29,334

 

Available-for-sale securities (1)

 

 

 

 

3,997

 

 

 

 

 

 

3,997

 

Total assets

$

 

 

$

33,331

 

 

$

 

 

$

33,331

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap (2)

$

 

 

$

673

 

 

$

 

 

$

673

 

Total liabilities

$

 

 

$

673

 

 

$

 

 

$

673

 

(1)
Fair value of cash equivalents (money market funds) and available-for-sale securities (commercial paper and corporate bond securities) was based on quoted vendor prices and broker pricing where all significant inputs are observable.
(2)
Fair value of interest rate swap is based on forward-looking, one-month term secured overnight financing rate (“Term SOFR”) spot rates and interest rate curves (Note 7).
v3.24.4
Supplemental Balance Sheet Information
3 Months Ended
Dec. 31, 2024
Balance Sheet Related Disclosures [Abstract]  
Supplemental Balance Sheet Information

5. Supplemental Balance Sheet Information

Investments — 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, 2024

 

(In thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Commercial paper and corporate bonds

 

$

 

 

$

 

 

$

 

 

$

 

Available-for-sale securities

 

$

 

 

$

 

 

$

 

 

$

 

 

 

 

September 30, 2024

 

(In thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Commercial paper and corporate bonds

 

$

3,997

 

 

$

 

 

$

 

 

$

3,997

 

Available-for-sale securities

 

$

3,997

 

 

$

 

 

$

 

 

$

3,997

 

Inventories

Inventories consisted of the following components:

 

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Raw materials

$

8,793

 

 

$

8,505

 

Work-in process

 

2,268

 

 

 

2,476

 

Finished products

 

4,200

 

 

 

4,187

 

Inventories

$

15,261

 

 

$

15,168

 

Prepaids and Other Assets, Current

Prepaids and other current assets consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Prepaid expenses and other

$

3,905

 

 

$

2,752

 

Irish research and development credits receivable

 

100

 

 

 

108

 

Prepaids and other

$

4,005

 

 

$

2,860

 

 

Intangible Assets

Intangible assets consisted of the following:

 

December 31, 2024

 

(Dollars in thousands)

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

9.3

 

 

$

11,066

 

 

$

(10,321

)

 

$

745

 

Developed technology

 

11.9

 

 

 

33,452

 

 

 

(14,215

)

 

 

19,237

 

Patents and other

 

14.9

 

 

 

2,338

 

 

 

(1,629

)

 

 

709

 

Total definite-lived intangible assets

 

 

 

 

46,856

 

 

 

(26,165

)

 

 

20,691

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

580

 

 

 

 

 

 

580

 

Intangible assets, net

 

 

 

$

47,436

 

 

$

(26,165

)

 

$

21,271

 

 

 

September 30, 2024

 

(Dollars in thousands)

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

9.3

 

 

$

11,870

 

 

$

(10,844

)

 

$

1,026

 

Developed technology

 

11.9

 

 

 

35,433

 

 

 

(14,222

)

 

 

21,211

 

Patents and other

 

14.9

 

 

 

2,338

 

 

 

(1,586

)

 

 

752

 

Total definite-lived intangible assets

 

 

 

 

49,641

 

 

 

(26,652

)

 

 

22,989

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

580

 

 

 

 

 

 

580

 

Intangible assets, net

 

 

 

$

50,221

 

 

$

(26,652

)

 

$

23,569

 

Intangible asset amortization expense was $0.9 million for each of the three months ended December 31, 2024 and 2023 . Based on the intangible assets in service as of December 31, 2024, estimated amortization expense for future fiscal years was as follows:

(In thousands)

 

 

Remainder of 2025

$

2,694

 

2026

 

2,741

 

2027

 

2,498

 

2028

 

2,488

 

2029

 

2,488

 

2030

 

2,262

 

Thereafter

 

5,520

 

Definite-lived intangible assets

$

20,691

 

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

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, 2024

$

8,010

 

 

$

36,630

 

 

$

44,640

 

Currency translation adjustment

 

 

 

 

(2,232

)

 

 

(2,232

)

Goodwill as of December 31, 2024

$

8,010

 

 

$

34,398

 

 

$

42,408

 

 

Other Assets, Noncurrent

Other noncurrent assets consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Operating lease right-of-use assets

$

2,820

 

 

$

3,028

 

Contract asset (1)

 

803

 

 

 

689

 

Other

 

784

 

 

 

376

 

Other assets

$

4,407

 

 

$

4,093

 

(1)
As of December 31, 2024 and September 30, 2024, the noncurrent portion of the contract asset associated with estimated SurVeil DCB profit-sharing (Note 3).

Accrued Other Liabilities

Accrued other liabilities consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Accrued professional fees

$

869

 

 

$

563

 

Accrued clinical study expense

 

377

 

 

 

499

 

Accrued purchases

 

828

 

 

 

1,023

 

Operating lease liabilities, current portion

 

1,049

 

 

 

1,040

 

Other

 

459

 

 

 

670

 

Total accrued other liabilities

$

3,582

 

 

$

3,795

 

Other Long-term Liabilities

Other long-term liabilities consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Deferred consideration (1)

$

1,669

 

 

$

1,661

 

Unrecognized tax benefits (2)

 

3,263

 

 

 

3,176

 

Operating lease liabilities, less current portion

 

2,387

 

 

 

2,648

 

Other

 

281

 

 

 

298

 

Other long-term liabilities

$

7,600

 

 

$

7,783

 

(1)
Deferred consideration consisted of the present value of a guaranteed payment to be made in connection with the fiscal 2021 Vetex acquisition (Note 11).
(2)
Unrecognized tax benefits include accrued interest and penalties, if applicable (Note 10).
v3.24.4
Debt
3 Months Ended
Dec. 31, 2024
Debt Disclosure [Abstract]  
Debt

6. Debt

Debt consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Revolving Credit Facility, Term SOFR + 3.00%, maturing October 1, 2027

$

5,000

 

 

$

5,000

 

Tranche 1 Term Loans, Term SOFR +5.75%, maturing October 1, 2027

 

25,000

 

 

 

25,000

 

Long-term debt, gross

 

30,000

 

 

 

30,000

 

Less: Unamortized debt issuance costs

 

(409

)

 

 

(446

)

Long-term debt, net

$

29,591

 

 

$

29,554

 

 

On October 14, 2022, the Company entered into a secured revolving credit facility and secured term loan facilities pursuant to a Credit, Security and Guaranty Agreement (the “MidCap Credit Agreement”) with Mid Cap Funding IV Trust, as agent, and MidCap Financial Trust, as term loan servicer and the lenders from time to time party thereto. The MidCap Credit Agreement provides for availability under a secured revolving line of credit of up to $25.0 million (the “Revolving Credit Facility”). Availability under the Revolving Credit Facility is subject to a borrowing base.

The MidCap Credit Agreement also provided for up to $75.0 million in term loans (the “Term Loans”), consisting of a $25.0 million Tranche 1 (“Tranche 1”) and a $50.0 million Tranche 2 (“Tranche 2”), which was available until December 31, 2024. The Company did not draw any amounts under Tranche 2 and the Tranche 2 commitment expired on December 31, 2024. Upon closing, the Company borrowed $25.0 million of Tranche 1, borrowed $5.0 million on the Revolving Credit Facility, and used approximately $10.0 million of the proceeds to repay borrowings under the revolving credit facility with Bridgewater Bank. The Company intends to use the remaining proceeds to fund working capital needs and for other general corporate purposes, as permitted under the MidCap Credit Agreement.

Pursuant to the MidCap Credit Agreement, the Company provided a first priority security interest in all existing and future acquired assets, including intellectual property and real estate, owned by the Company. The MidCap Credit Agreement contains certain covenants that limit the Company’s ability to engage in certain transactions. Subject to certain limited exceptions, these covenants limit the Company’s ability to, among other things:

create, incur, assume or permit to exist any additional indebtedness, or create, incur, allow or permit to exist any additional liens;
enter into any amendment or other modification of certain agreements;
effect certain changes in the Company’s business, fiscal year, management, entity name or business locations;
liquidate or dissolve, merge with or into, or consolidate with, any other company;
pay cash dividends on, make any other distributions in respect of, or redeem, retire or repurchase, any shares of the Company’s capital stock;
make certain investments, other than limited permitted acquisitions; and
enter into transactions with the Company’s affiliates.

The MidCap Credit Agreement also contains customary indemnification obligations and customary events of default, including, among other things, (i) non-payment, (ii) breach of warranty, (iii) non-performance of covenants and obligations, (iv) default on other indebtedness, (v) judgments, (vi) change of control, (vii) bankruptcy and insolvency, (viii) impairment of security, (ix) termination of a pension plan, (x) regulatory matters, and (xi) material adverse effect.

In the event of default under the MidCap Credit Agreement, the Company would be required to pay interest on principal and all other due and unpaid obligations at the current rate in effect plus 2%.

Borrowings under the MidCap Credit Agreement bear interest at Term SOFR as published by CME Group Benchmark Administration Limited plus 0.10% (“Adjusted Term SOFR”). The Revolving Credit Facility bears interest at an annual rate equal to 3.00% plus the greater of Adjusted Term SOFR or 1.50%, and the Term Loans bear interest at an annual rate equal to 5.75% plus the greater of Adjusted Term SOFR or 1.50%. The Company is required to make monthly interest payments on the Revolving Credit Facility with the entire principal payment due at maturity. The Company is required to make 48 monthly interest payments on the Term Loans beginning on November 1, 2022 (the “Interest-Only Period”). If the Company is in covenant compliance at the end of the Interest-Only Period, the Company will have the option to extend the Interest-Only Period through maturity with the entire principal payment due at maturity. If the Company is not in covenant compliance at the end of the Interest-Only Period, the Company is required to make 12 months of straight-line amortization payments with the entire principal amount due at maturity.

Subject to certain limitations, the Term Loans have a prepayment fee for payments made prior to the maturity date equal to 1.0% of the prepaid principal amount for the third year following the closing date and thereafter. In addition, if the Revolving Credit Facility is terminated in whole or in part prior to the maturity date, the Company must pay a prepayment fee equal to 1.0% of the terminated commitment amount for the third year following the closing date of the MidCap Credit Agreement and thereafter. The Company is also required to pay a full exit fee at the time of maturity or full prepayment event equal to 2.5% of the aggregate principal amount of the Term Loans made pursuant to the MidCap Credit Agreement and a partial exit fee at the time of any partial prepayment event equal to 2.5% of the amount prepaid. This exit fee is accreted over the remaining term of the Term Loans. The Company also is obligated to pay customary origination fees at the time of each funding of the Term Loans and a customary annual administrative fee based on the amount borrowed under the Term Loan, due on an annual basis. The customary fees on the Revolving Credit Facility

include (i) an origination fee based on the commitment amount, which was paid on the closing date, (ii) an annual collateral management fee of 0.50% per annum based on the outstanding balance of the Revolving Credit Facility, payable monthly in arrears and (iii) an unused line fee of 0.50% per annum based on the average unused portion of the Revolving Credit Facility, payable monthly in arrears. The Company must also maintain a minimum balance of no less than 20% of availability under the Revolving Credit Facility or a minimum balance fee applies of 0.50% per annum. Expenses recognized for fees for the Revolving Credit Facility and Term Loans are reported in interest expense, net on the condensed consolidated statements of operations.

v3.24.4
Derivative Financial Instruments
3 Months Ended
Dec. 31, 2024
Derivative Instruments and Hedging Activities Disclosure [Abstract]  
Derivative Financial Instruments

7. Derivative Financial Instruments

As of December 31, 2024 and September 30, 2024, derivative financial instruments on the condensed consolidated balance sheets consisted of a fixed-to-variable interest rate swap to mitigate exposure to interest rate increases related to our Term Loans (“interest rate swap”). The interest rate swap has been designated as a cash flow hedge. See Note 6 Debt for further information on our financing arrangements. The net fair value of designated hedge derivatives subject to master netting arrangements reported on the condensed consolidated balance sheets was as follows:

 

Asset (Liability)

(In thousands)

Gross Recognized Amount

 

 

Gross Offset Amount

 

 

Net Amount Presented

 

 

Cash Collateral Receivable

 

 

Net Amount Reported

 

 

Balance Sheet Location

December 31, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap

$

(196

)

 

$

 

 

$

(196

)

 

$

436

 

 

$

240

 

 

Other assets, noncurrent

September 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap

$

(673

)

 

$

 

 

$

(673

)

 

$

625

 

 

$

(48

)

 

Other long-term liabilities

The pretax amounts recognized in accumulated other comprehensive loss (“AOCL”) for designated hedge derivative instruments were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

 

2024

 

 

2023

 

Beginning unrealized net (loss) gain in AOCL

 

$

(673

)

 

$

183

 

Net gain (loss) recognized in other comprehensive (loss) income

 

 

506

 

 

 

(620

)

Net gain (loss) reclassified into interest expense

 

 

(29

)

 

 

(62

)

Ending unrealized (loss) gain in AOCL

 

$

(196

)

 

$

(499

)

v3.24.4
Stock-based Compensation Plans
3 Months Ended
Dec. 31, 2024
Share-Based Payment Arrangement [Abstract]  
Stock-based Compensation Plans

8. Stock-based Compensation Plans

The Company has stock-based compensation plans approved by its 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)

2024

 

 

2023

 

Product costs

$

59

 

 

$

72

 

Research and development

 

301

 

 

 

370

 

Selling, general and administrative

 

1,383

 

 

 

1,526

 

Total

$

1,743

 

 

$

1,968

 

As of December 31, 2024, unrecognized compensation costs related to non-vested awards totaled approximately $9.1 million, which is expected to be recognized over a weighted average period of approximately 2.0 years.

Stock Option Awards

The Company awards stock options to officers, directors and key employees and uses the Black-Scholes option pricing model to determine the fair value of stock options as of the date of each grant. Stock option grant activity was as follows:

 

Three Months Ended December 31,

 

 

2024

 

 

2023

 

Stock option grant activity:

 

 

 

 

 

Stock options granted

 

-

 

 

 

250,000

 

Weighted average grant date fair value

$

-

 

 

$

15.82

 

Weighted average exercise price

$

-

 

 

$

33.64

 

Restricted Stock Awards

During the three months ended December 31, 2024, the Company did not award any shares of restricted stock. During the three months ended December 31, 2023, the Company awarded 98,000 shares of restricted stock to certain key employees and officers with a weighted average grant date fair value per share of $33.64. Restricted stock is valued based on the market value of the shares as of the date of grant.

Restricted Stock Unit Awards

During the three months ended December 31, 2024, the Company did not award any restricted stocks (“RSU’s”). During the three months ended December 31, 2023, the Company awarded 5,000 RSU’s to directors and key employees in foreign jurisdictions with a weighted average grant date fair value per unit of $33.64. RSUs are valued based on the market value of the shares as of the date of grant.

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 each of the three months ended December 31, 2024 and 2023 no shares were issued under the ESPP.

v3.24.4
Net (Loss) Income Per Share Data
3 Months Ended
Dec. 31, 2024
Earnings Per Share [Abstract]  
Net (Loss) Income Per Share Data

9. 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 (loss) 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 RSUs.

The calculation of diluted loss per share excluded 0.1 million or less in weighted-average shares for each of the three-month periods ended December 31, 2024 and 2023, as their effect was anti-dilutive. Basic and diluted weighted average shares outstanding were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Basic weighted average shares outstanding

 

14,231

 

 

 

14,102

 

Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units

 

 

 

 

 

Diluted weighted average shares outstanding

 

14,231

 

 

 

14,102

 

v3.24.4
Income Taxes
3 Months Ended
Dec. 31, 2024
Income Tax Disclosure [Abstract]  
Income Taxes

10. Income Taxes

For interim income tax reporting, the Company estimates its full-year 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 reported income tax expense of $(0.7) million and $(0.1) million for the three months ended December 31, 2024 and 2023, respectively.

Beginning in our fiscal 2023, certain research and development (“R&D”) costs are required to be capitalized and amortized over a five-year period under the Tax Cuts and Jobs Act enacted in December 2017. This change impacts the expected U.S. federal and state income tax expense and cash taxes paid and to be paid for our fiscal 2025 and 2024.
Since September 30, 2022, we have maintained a full valuation allowance against U.S. net deferred tax assets. As a result, we are no longer recording a tax benefit associated with U.S. pretax losses and incremental deferred tax assets.
Recurring items cause our effective tax rate to differ from the U.S. federal statutory rate of 21%, including foreign-derived intangible income (“FDII”) deductions in the U.S., U.S. federal and Irish R&D credits, Irish and U.S. state tax rates, excess tax benefits associated with stock-based compensation, and non-deductible merger-related charges (Note 13).

A valuation allowance is required to be recognized against deferred tax assets if, based on the available evidence, it is more likely than not (defined as a likelihood of more than 50%) that all or a portion of such assets will not be realized. We apply judgment to consider the relative impact of negative and positive evidence, and the weight given to negative and positive evidence is commensurate with the extent to which such evidence can be objectively verified. Objective historical evidence, such as cumulative three-year pre-tax losses adjusted for permanent adjustments, is given greater weight than subjective positive evidence, such as forecasts of future earnings. The more objective negative evidence that exists limits our ability to consider other, potentially positive, subjective evidence, such as our future earnings projections. Based on our evaluation of all available positive and negative evidence, and by placing greater weight on the objectively verifiable evidence, we determined, as of December 31, 2024 and September 30, 2024, that it is more likely than not that our net U.S. deferred tax assets will not be realized. Due to significant estimates used to establish the valuation allowance and the potential for changes in facts and circumstances, it is reasonably possible that we will be required to record additional adjustments to the valuation allowance in future reporting periods that could have a material effect on our results of operations.

Discrete tax benefits related to stock-based compensation awards vested, expired, canceled and exercised was $0.1 million or less for each of the three months ended December 31, 2024 and 2023. The total amount of unrecognized tax benefits, excluding interest and penalties that, if recognized, would affect the effective tax rate was $3.2 million and $2.8 million as of December 31, 2024 and September 30, 2024, respectively. Interest and penalties related to unrecognized tax benefits are recorded in income tax expense.

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. The Internal Revenue Service commenced an examination of the Company’s fiscal 2019 U.S. federal tax return in fiscal 2022; the examination has been completed. U.S. federal income tax returns for years prior to fiscal 2020 are no longer subject to examination by federal tax authorities. For tax returns for U.S. state and local jurisdictions, the Company is no longer subject to examination for tax years generally before fiscal 2015. For tax returns for non-U.S. jurisdictions, the Company is no longer subject to income tax examination for years prior to 2020. Additionally, the Company has been indemnified of liability for any taxes relating to the fiscal 2021 acquisition of Vetex Medical Limited (“Vetex”) and the fiscal 2016 acquisitions of Creagh Medical, Ltd and NorMedix, Inc. for periods prior to the 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, 2024 and September 30, 2024.

v3.24.4
Commitments and Contingencies
3 Months Ended
Dec. 31, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

11. Commitments and Contingencies

Asset Acquisition. 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 fiscal 2020, $1.0 million in fiscal 2021, $0.5 million in fiscal 2022, $1.0 million in fiscal 2023, and $0.9 million in fiscal 2024. An additional $1.0 million payment is contingent upon the achievement of a certain regulatory milestone within a contingency period ending in 2033.

Vetex Acquisition. In fiscal 2021, Surmodics acquired all of the outstanding shares of Vetex with an upfront cash payment of $39.9 million. The Company paid the sellers $1.8 million in the fourth quarter of fiscal 2024. The Company is obligated to pay an additional installment of $1.8 million in fiscal 2027. An additional $3.5 million in payments is contingent upon the achievement of certain product development and regulatory milestones within a contingency period ending in fiscal 2027.

v3.24.4
Segment Information
3 Months Ended
Dec. 31, 2024
Segment Reporting [Abstract]  
Segment Information

12. Segment Information

Segment revenue, operating (loss) income, and depreciation and amortization were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Revenue:

 

 

 

 

 

Medical Device

$

23,281

 

 

$

23,545

 

In Vitro Diagnostics

 

6,641

 

 

 

7,007

 

Total revenue

$

29,922

 

 

$

30,552

 

 

 

 

 

 

 

Operating (loss) income:

 

 

 

 

 

Medical Device

$

161

 

 

$

(224

)

In Vitro Diagnostics

 

2,922

 

 

 

3,124

 

Total segment operating income

 

3,083

 

 

 

2,900

 

Corporate

 

(5,564

)

 

 

(3,222

)

Total operating (loss) income

$

(2,481

)

 

$

(322

)

 

 

 

 

 

 

Depreciation and amortization:

 

 

 

 

 

Medical Device

$

1,924

 

 

$

2,054

 

In Vitro Diagnostics

 

91

 

 

 

97

 

Corporate

 

68

 

 

 

182

 

Total depreciation and amortization

$

2,083

 

 

$

2,333

 

The Corporate category includes expenses that are not fully allocated to the Medical Device and In Vitro Diagnostics segments. These Corporate costs are related to administrative corporate functions, such as executive management, corporate accounting, information technology, legal, human resources and Board of Directors. Corporate may also include expenses, such as litigation and merger-and-acquisition-related costs, which are not specific to a segment and thus not allocated to the reportable 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.

v3.24.4
Merger Agreement
3 Months Ended
Dec. 31, 2024
Business Combinations [Abstract]  
Merger Agreement

13. Merger Agreement

On May 28, 2024, Surmodics entered into the Merger Agreement with Parent and Merger Sub (Note 1). Pursuant to the Merger Agreement, and subject to the terms and conditions thereof, Merger Sub will merge (the “Merger”) with and into the Company, with the Company as the surviving corporation and a wholly owned subsidiary of Parent. At the effective time of the Merger (the “Effective Time”), each share of common stock of the Company then outstanding (other than (1) those shares owned by Merger Sub, Parent, the Company, or any direct or indirect wholly owned subsidiary of Parent or the Company (which will be cancelled without any consideration), (2) any shares outstanding immediately prior to the Effective Time and held of record or beneficially by a Person who has not voted in favor of approval of this Agreement and who is entitled to demand and properly demands and perfects such holder’s dissenter’s rights with respect to such shares, and (3) any shares that have been issued as a restricted stock award pursuant to any of the Stock Incentive Plans (as defined in the Merger Agreement) and that remains unvested and subject to forfeiture thereunder (“Restricted Shares”) (which will be treated as described below)) will be converted into the right to receive $43.00 in cash, without interest (the “Merger Consideration”). The Merger is not subject to a financing condition. If the Merger is consummated, shares of our common stock will be delisted from The Nasdaq Stock Market and deregistered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

During the three months ended December 31, 2024, we incurred a total of $2.3 million in Merger-related charges, which we reported within selling, general and administrative expenses on the condensed consolidated statements of operations.

Merger Consideration

The Merger Agreement provides that, at the Effective Time, each of the Company’s then outstanding equity awards will be treated as follows: (1) each restricted stock unit or deferred stock unit that has been issued pursuant to any of the Stock Incentive Plans will be cancelled in exchange for an amount in cash equal to the Merger Consideration net of any taxes withheld pursuant to the Merger Agreement; (2) each Restricted Share will be cancelled in exchange for an amount in cash equal to the Merger Consideration, net of

any taxes withheld pursuant to the Merger Agreement; and (3) each unexercised option to acquire Company common stock will be (i) if the Merger Consideration for such option is equal to or greater than the exercise price per share of Company common stock subject to such option, cancelled in exchange for an amount in cash equal to the excess, if any, of the Merger Consideration over the exercise price per share of Company common stock subject to such option multiplied by the number of shares of Company common stock subject to such option, and (ii) if the Merger Consideration for such option is less than the exercise price per share of Company common stock subject to such option, cancelled for no consideration.

Conditions

The obligations of the parties to consummate the Merger are subject to the satisfaction or waiver of closing conditions set forth in the Merger Agreement, including (1) the approval of the Company’s shareholders, (2) the expiration or termination of any waiting period applicable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), (3) the absence of a “Company Material Adverse Effect” (as defined in the Merger Agreement) with respect to the Company and (4) other customary closing conditions, including the absence of any injunction or other legal restraint or prohibition that would prevent or prohibit the consummation of the Merger.

The Merger was approved by Surmodics’ shareholders at a special meeting on August 13, 2024. On the same date, the Company announced that it and an affiliate of Parent each received a request for additional information and documentary materials (a “Second Request”) from the U.S. Federal Trade Commission (“FTC”) in connection with the Merger. As of December 31, 2024, the Merger remains subject to the expiration or termination of a voluntary agreement with the FTC not to consummate the Merger for a period of time following substantial compliance with the Second Requests. The Company and Parent remain engaged with the FTC with the goal of consummating the Merger in accordance with the definitive agreement for the Merger in the Company’s second fiscal quarter ending March 31, 2025 if all the remaining closing conditions are satisfied.

Termination Rights & Fees

The Merger Agreement may be terminated with the mutual written consent of Parent and the Company and also contains termination rights for each of Parent and the Company, including, among others, (1) if the Merger has not been consummated by February 28, 2025 (which date may be extended one or more times, for up to nine additional months in total, under specified circumstances), (2) if a final and non-appealable judgment or law makes consummation of the Merger illegal or prevents the consummation of the Merger, (3) if the required approval of the Company’s shareholders is not obtained, or (4) in the case of a material uncured breach by the other party, in each case as further described in, and subject to the terms and conditions of, the Merger Agreement. Parent may terminate the Merger Agreement in certain circumstances generally related to an adverse change in the Company’s board of directors’ recommendation in favor of the Merger and, as further described below, the Company may terminate the Merger Agreement to accept a Superior Proposal, as further described in, and subject to the terms and conditions of, the Merger Agreement.

Upon termination of the Merger Agreement under specified circumstances, generally relating to alternative acquisition proposals or an adverse change in the Company’s board of directors’ recommendation in favor of the Merger, the Company would be required to pay Parent a termination fee of $20.4 million. Upon termination of the Merger Agreement under specified circumstances, generally relating to a failure of the Merger to be completed due to certain regulatory impediments, Parent would be required to pay the Company a reverse termination fee of $50.2 million. In certain other circumstances, generally related to a failure by Parent to consummate the Merger when required to do so pursuant to the terms of the Merger Agreement, Parent would be required to pay the Company a reverse termination fee of $47.0 million. The Merger Agreement also contains restrictions on the Company’s ability to seek specific performance of Parent’s obligation to consummate the Merger and generally limits the aggregate liability of Parent for a breach of the Merger Agreement to the amount of the termination fee payable by Parent to the Company.

The foregoing description of the Merger and the Merger Agreement does not purport to be and is not complete and is subject to and qualified in its entirety by reference to the full text of the Merger Agreement.

v3.24.4
Organization (Policies)
3 Months Ended
Dec. 31, 2024
Accounting Policies [Abstract]  
Description of Business

Description of Business

Surmodics, Inc. and subsidiaries (referred to as “Surmodics,” the “Company,” “we,” “us,” “our” and other like terms) is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic (“IVD”) immunoassay tests and microarrays. Surmodics develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. Our key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota.

On May 28, 2024, Surmodics entered into a Merger Agreement (the “Merger Agreement”) with BCE Parent, LLC, a Delaware limited liability company (“Parent”), and BCE Merger Sub, Inc., a Minnesota corporation and a wholly owned Subsidiary of Parent (“Merger Sub”), pursuant to which Surmodics will, subject to the terms and conditions thereof, be acquired by Parent for $43.00 per share in cash through the merger of Merger Sub with and into the Company, with the Company as the surviving corporation and a wholly owned subsidiary of Parent. See Note 13 Merger Agreement for additional information.

Basis of Presentation and Principles of Consolidation

Basis of Presentation and Principles of Consolidation

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, 2024, and notes thereto included in our Annual Report on Form 10-K as filed with the SEC.

Use of Estimates

Use of Estimates

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 liabilities at the date of the condensed 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, 2024 are not necessarily indicative of the results that may be expected for the entire 2025 fiscal year.

New Accounting Pronouncements

New Accounting Pronouncements

Not Yet Adopted

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures. This guidance requires disclosure of incremental segment information on an annual and interim basis. This amendment is effective for our fiscal year ending September 30, 2025 and interim periods within our fiscal year ending September 30, 2026. We are currently assessing the impact of this guidance on our disclosures.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes: Improvements to Income Tax Disclosures. This guidance requires consistent categories and greater disaggregation of information in the rate reconciliation and disclosures of income taxes paid by jurisdiction. This amendment is effective for our fiscal year ending September 30, 2026 and interim periods within our fiscal year ending September 30, 2027. We are currently assessing the impact of this guidance on our disclosures.

No other new accounting pronouncement issued or effective during our fiscal year ending September 30, 2025, or is expected to have, a material impact on the Company’s condensed consolidated financial statements.

Net Loss 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 (loss) 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 RSUs.

The calculation of diluted loss per share excluded 0.1 million or less in weighted-average shares for each of the three-month periods ended December 31, 2024 and 2023, as their effect was anti-dilutive. Basic and diluted weighted average shares outstanding were as follows:

Income Taxes For interim income tax reporting, the Company estimates its full-year 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.
Income Tax Uncertainties 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. The Internal Revenue Service commenced an examination of the Company’s fiscal 2019 U.S. federal tax return in fiscal 2022; the examination has been completed. U.S. federal income tax returns for years prior to fiscal 2020 are no longer subject to examination by federal tax authorities. For tax returns for U.S. state and local jurisdictions, the Company is no longer subject to examination for tax years generally before fiscal 2015. For tax returns for non-U.S. jurisdictions, the Company is no longer subject to income tax examination for years prior to 2020.
v3.24.4
Revenue (Tables)
3 Months Ended
Dec. 31, 2024
Revenue from Contract with Customer [Abstract]  
Summary of Disaggregation of Revenue Within Reportable Segment

The following table is a disaggregation of revenue within each reportable segment.

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Medical Device

 

 

Product sales

$

10,116

 

 

$

11,950

 

Royalties & license fees – performance coatings

 

9,383

 

 

 

8,208

 

License fees – SurVeil DCB

 

1,251

 

 

 

971

 

Research, development and other

 

2,531

 

 

 

2,416

 

Medical Device Revenue

 

23,281

 

 

 

23,545

 

In Vitro Diagnostics

 

 

 

 

 

Product sales

 

6,432

 

 

 

6,877

 

Research, development and other

 

209

 

 

 

130

 

In Vitro Diagnostics Revenue

 

6,641

 

 

 

7,007

 

Total Revenue

$

29,922

 

 

$

30,552

 

v3.24.4
Fair Value Measurements (Tables)
3 Months Ended
Dec. 31, 2024
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, 2024

 

(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 (1)

$

 

 

$

23,228

 

 

$

 

 

$

23,228

 

Available-for-sale securities (1)

 

 

 

 

 

 

 

 

 

 

 

Total assets

$

 

 

$

23,228

 

 

$

 

 

$

23,228

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap (2)

 

 

 

 

196

 

 

 

 

 

 

196

 

Total liabilities

$

 

 

$

196

 

 

$

 

 

$

196

 

 

 

September 30, 2024

 

(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 (1)

$

 

 

$

29,334

 

 

$

 

 

$

29,334

 

Available-for-sale securities (1)

 

 

 

 

3,997

 

 

 

 

 

 

3,997

 

Total assets

$

 

 

$

33,331

 

 

$

 

 

$

33,331

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap (2)

$

 

 

$

673

 

 

$

 

 

$

673

 

Total liabilities

$

 

 

$

673

 

 

$

 

 

$

673

 

(1)
Fair value of cash equivalents (money market funds) and available-for-sale securities (commercial paper and corporate bond securities) was based on quoted vendor prices and broker pricing where all significant inputs are observable.
(2)
Fair value of interest rate swap is based on forward-looking, one-month term secured overnight financing rate (“Term SOFR”) spot rates and interest rate curves (Note 7).
v3.24.4
Supplemental Balance Sheet Information (Tables)
3 Months Ended
Dec. 31, 2024
Balance Sheet Related Disclosures [Abstract]  
Amortized Cost, Unrealized Holding Gains (Losses) and Fair Value of Available for Sale Securities

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

 

 

 

December 31, 2024

 

(In thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Commercial paper and corporate bonds

 

$

 

 

$

 

 

$

 

 

$

 

Available-for-sale securities

 

$

 

 

$

 

 

$

 

 

$

 

 

 

 

September 30, 2024

 

(In thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Commercial paper and corporate bonds

 

$

3,997

 

 

$

 

 

$

 

 

$

3,997

 

Available-for-sale securities

 

$

3,997

 

 

$

 

 

$

 

 

$

3,997

 

Components of Inventories, net

Inventories consisted of the following components:

 

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Raw materials

$

8,793

 

 

$

8,505

 

Work-in process

 

2,268

 

 

 

2,476

 

Finished products

 

4,200

 

 

 

4,187

 

Inventories

$

15,261

 

 

$

15,168

 

Summary of Prepaids and Other Current Assets

Prepaids and other current assets consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Prepaid expenses and other

$

3,905

 

 

$

2,752

 

Irish research and development credits receivable

 

100

 

 

 

108

 

Prepaids and other

$

4,005

 

 

$

2,860

 

 

Schedule of Intangible Assets

Intangible assets consisted of the following:

 

December 31, 2024

 

(Dollars in thousands)

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

9.3

 

 

$

11,066

 

 

$

(10,321

)

 

$

745

 

Developed technology

 

11.9

 

 

 

33,452

 

 

 

(14,215

)

 

 

19,237

 

Patents and other

 

14.9

 

 

 

2,338

 

 

 

(1,629

)

 

 

709

 

Total definite-lived intangible assets

 

 

 

 

46,856

 

 

 

(26,165

)

 

 

20,691

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

580

 

 

 

 

 

 

580

 

Intangible assets, net

 

 

 

$

47,436

 

 

$

(26,165

)

 

$

21,271

 

 

 

September 30, 2024

 

(Dollars in thousands)

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

9.3

 

 

$

11,870

 

 

$

(10,844

)

 

$

1,026

 

Developed technology

 

11.9

 

 

 

35,433

 

 

 

(14,222

)

 

 

21,211

 

Patents and other

 

14.9

 

 

 

2,338

 

 

 

(1,586

)

 

 

752

 

Total definite-lived intangible assets

 

 

 

 

49,641

 

 

 

(26,652

)

 

 

22,989

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

580

 

 

 

 

 

 

580

 

Intangible assets, net

 

 

 

$

50,221

 

 

$

(26,652

)

 

$

23,569

 

Estimated Amortization Expense Based on the intangible assets in service as of December 31, 2024, estimated amortization expense for future fiscal years was as follows:

(In thousands)

 

 

Remainder of 2025

$

2,694

 

2026

 

2,741

 

2027

 

2,498

 

2028

 

2,488

 

2029

 

2,488

 

2030

 

2,262

 

Thereafter

 

5,520

 

Definite-lived intangible assets

$

20,691

 

Schedule of Carrying Amount of Goodwill By Reportable Segment

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, 2024

$

8,010

 

 

$

36,630

 

 

$

44,640

 

Currency translation adjustment

 

 

 

 

(2,232

)

 

 

(2,232

)

Goodwill as of December 31, 2024

$

8,010

 

 

$

34,398

 

 

$

42,408

 

 

Summary of Other Noncurrent Assets

Other noncurrent assets consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Operating lease right-of-use assets

$

2,820

 

 

$

3,028

 

Contract asset (1)

 

803

 

 

 

689

 

Other

 

784

 

 

 

376

 

Other assets

$

4,407

 

 

$

4,093

 

(1)
As of December 31, 2024 and September 30, 2024, the noncurrent portion of the contract asset associated with estimated SurVeil DCB profit-sharing (Note 3).
Schedule of Accrued Other Liabilities

Accrued other liabilities consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Accrued professional fees

$

869

 

 

$

563

 

Accrued clinical study expense

 

377

 

 

 

499

 

Accrued purchases

 

828

 

 

 

1,023

 

Operating lease liabilities, current portion

 

1,049

 

 

 

1,040

 

Other

 

459

 

 

 

670

 

Total accrued other liabilities

$

3,582

 

 

$

3,795

 

Schedule of Other Long-term Liabilities

Other long-term liabilities consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Deferred consideration (1)

$

1,669

 

 

$

1,661

 

Unrecognized tax benefits (2)

 

3,263

 

 

 

3,176

 

Operating lease liabilities, less current portion

 

2,387

 

 

 

2,648

 

Other

 

281

 

 

 

298

 

Other long-term liabilities

$

7,600

 

 

$

7,783

 

(1)
Deferred consideration consisted of the present value of a guaranteed payment to be made in connection with the fiscal 2021 Vetex acquisition (Note 11).
(2)
Unrecognized tax benefits include accrued interest and penalties, if applicable (Note 10).
v3.24.4
Debt (Tables)
3 Months Ended
Dec. 31, 2024
Debt Disclosure [Abstract]  
Schedule of Debt

Debt consisted of the following:

 

December 31,

 

 

September 30,

 

(In thousands)

2024

 

 

2024

 

Revolving Credit Facility, Term SOFR + 3.00%, maturing October 1, 2027

$

5,000

 

 

$

5,000

 

Tranche 1 Term Loans, Term SOFR +5.75%, maturing October 1, 2027

 

25,000

 

 

 

25,000

 

Long-term debt, gross

 

30,000

 

 

 

30,000

 

Less: Unamortized debt issuance costs

 

(409

)

 

 

(446

)

Long-term debt, net

$

29,591

 

 

$

29,554

 

 

v3.24.4
Derivative Financial Instruments (Tables)
3 Months Ended
Dec. 31, 2024
Derivative Instruments and Hedging Activities Disclosure [Abstract]  
Schedule of Net Fair Value of Designated Hedge Derivatives Subject to Master Netting Arrangements Reported on Condensed Consolidated Balance Sheets The net fair value of designated hedge derivatives subject to master netting arrangements reported on the condensed consolidated balance sheets was as follows:

 

Asset (Liability)

(In thousands)

Gross Recognized Amount

 

 

Gross Offset Amount

 

 

Net Amount Presented

 

 

Cash Collateral Receivable

 

 

Net Amount Reported

 

 

Balance Sheet Location

December 31, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap

$

(196

)

 

$

 

 

$

(196

)

 

$

436

 

 

$

240

 

 

Other assets, noncurrent

September 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest rate swap

$

(673

)

 

$

 

 

$

(673

)

 

$

625

 

 

$

(48

)

 

Other long-term liabilities

Schedule of Pretax Amounts Recognized in Accumulated Other Comprehensive Loss ("AOCL") for Designated Hedge Derivative Instruments

The pretax amounts recognized in accumulated other comprehensive loss (“AOCL”) for designated hedge derivative instruments were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

 

2024

 

 

2023

 

Beginning unrealized net (loss) gain in AOCL

 

$

(673

)

 

$

183

 

Net gain (loss) recognized in other comprehensive (loss) income

 

 

506

 

 

 

(620

)

Net gain (loss) reclassified into interest expense

 

 

(29

)

 

 

(62

)

Ending unrealized (loss) gain in AOCL

 

$

(196

)

 

$

(499

)

v3.24.4
Stock-based Compensation Plans (Tables)
3 Months Ended
Dec. 31, 2024
Share-Based Payment Arrangement [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)

2024

 

 

2023

 

Product costs

$

59

 

 

$

72

 

Research and development

 

301

 

 

 

370

 

Selling, general and administrative

 

1,383

 

 

 

1,526

 

Total

$

1,743

 

 

$

1,968

 

Summary of Stock Option Grant Activity Stock option grant activity was as follows:

 

Three Months Ended December 31,

 

 

2024

 

 

2023

 

Stock option grant activity:

 

 

 

 

 

Stock options granted

 

-

 

 

 

250,000

 

Weighted average grant date fair value

$

-

 

 

$

15.82

 

Weighted average exercise price

$

-

 

 

$

33.64

 

v3.24.4
Net (Loss) Income Per Share Data (Tables)
3 Months Ended
Dec. 31, 2024
Earnings Per Share [Abstract]  
Basic and Diluted Weighted Average Shares Outstanding Basic and diluted weighted average shares outstanding were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Basic weighted average shares outstanding

 

14,231

 

 

 

14,102

 

Dilutive effect of outstanding stock options, non-vested restricted stock, and non-vested restricted stock units

 

 

 

 

 

Diluted weighted average shares outstanding

 

14,231

 

 

 

14,102

 

v3.24.4
Segment Information (Tables)
3 Months Ended
Dec. 31, 2024
Segment Reporting [Abstract]  
Segment Revenue, Operating (Loss) Income and Depreciation and Amortization

Segment revenue, operating (loss) income, and depreciation and amortization were as follows:

 

 

Three Months Ended December 31,

 

(In thousands)

2024

 

 

2023

 

Revenue:

 

 

 

 

 

Medical Device

$

23,281

 

 

$

23,545

 

In Vitro Diagnostics

 

6,641

 

 

 

7,007

 

Total revenue

$

29,922

 

 

$

30,552

 

 

 

 

 

 

 

Operating (loss) income:

 

 

 

 

 

Medical Device

$

161

 

 

$

(224

)

In Vitro Diagnostics

 

2,922

 

 

 

3,124

 

Total segment operating income

 

3,083

 

 

 

2,900

 

Corporate

 

(5,564

)

 

 

(3,222

)

Total operating (loss) income

$

(2,481

)

 

$

(322

)

 

 

 

 

 

 

Depreciation and amortization:

 

 

 

 

 

Medical Device

$

1,924

 

 

$

2,054

 

In Vitro Diagnostics

 

91

 

 

 

97

 

Corporate

 

68

 

 

 

182

 

Total depreciation and amortization

$

2,083

 

 

$

2,333

 

v3.24.4
Organization - Additional Information (Detail)
May 28, 2024
$ / shares
BCE Parent LLC and BCE Merger Sub Inc [Member] | GTCR Merger Agreement [Member]  
Summary Of Significant Accounting Policies [Line Items]  
Share acquired price per share in cash $ 43
v3.24.4
Revenue - Summary of Disaggregation of Revenue Within Reportable Segment (Detail) - USD ($)
$ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Disaggregation Of Revenue [Line Items]    
Total revenue $ 29,922 $ 30,552
Product Sales [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 16,548 18,827
Royalties [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 10,634 9,179
Research, Development and Other [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 2,740 2,546
Operating Segments [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 29,922 30,552
Operating Segments [Member] | Medical Device [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 23,281 23,545
Operating Segments [Member] | Medical Device [Member] | Product Sales [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 10,116 11,950
Operating Segments [Member] | Medical Device [Member] | Royalties [Member] | Performance Coatings [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 9,383 8,208
Operating Segments [Member] | Medical Device [Member] | License Fees [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 1,251 971
Operating Segments [Member] | Medical Device [Member] | Research, Development and Other [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 2,531 2,416
Operating Segments [Member] | In Vitro Diagnostics [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 6,641 7,007
Operating Segments [Member] | In Vitro Diagnostics [Member] | Product Sales [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue 6,432 6,877
Operating Segments [Member] | In Vitro Diagnostics [Member] | Research, Development and Other [Member]    
Disaggregation Of Revenue [Line Items]    
Total revenue $ 209 $ 130
v3.24.4
Revenue - Additional Information (Detail) - USD ($)
$ in Millions
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Sep. 30, 2024
Disaggregation of Revenue [Line Items]      
Total contract assets $ 10.7   $ 10.6
Deferred revenue, total 0.3   $ 1.6
Revenue recognized included in deferred revenue balance at beginning of period $ 1.3 $ 1.0  
v3.24.4
Collaborative Arrangement - Additional Information (Detail) - USD ($)
$ in Thousands
3 Months Ended 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Jun. 30, 2023
Sep. 30, 2021
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2024
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Total revenue $ 29,922 $ 30,552            
Revenue recognized included in deferred revenue balance at beginning of period 1,300 1,000            
Deferred revenue, total 300             $ 1,600
Royalties and License Fees [Member]                
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Total revenue 10,634 $ 9,179            
Abbott Agreement [Member]                
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Collaborative arrangement payment received 87,800              
Deferred revenue, total $ 300              
Abbott Agreement [Member] | Upfront Payment [Member]                
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Collaborative arrangement payment received             $ 25,000  
Abbott Agreement [Member] | Milestone Payment [Member]                
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Collaborative arrangement payment received     $ 27,000 $ 15,000 $ 10,800 $ 10,000    
v3.24.4
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, 2024
Sep. 30, 2024
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items]    
Assets measured at fair value $ 23,228 $ 33,331
Liabilities measured at fair value 196 673
Available-for-sale securities [Member]    
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items]    
Assets measured at fair value 0 3,997
Significant Other Observable Inputs (Level 2) [Member]    
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items]    
Assets measured at fair value 23,228 33,331
Liabilities measured at fair value 196 673
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 0 3,997
Cash equivalents [Member]    
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items]    
Assets measured at fair value 23,228 29,334
Cash equivalents [Member] | Significant Other Observable Inputs (Level 2) [Member]    
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items]    
Assets measured at fair value 23,228 29,334
Interest Rate Swap [Member]    
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items]    
Liabilities measured at fair value 196 673
Interest Rate Swap [Member] | Significant Other Observable Inputs (Level 2) [Member]    
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items]    
Liabilities measured at fair value $ 196 $ 673
v3.24.4
Supplemental Balance Sheet Information - Amortized Cost, Unrealized Holding Gains and (Losses) and Fair Value of Available-for-sale Securities (Details) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Debt Securities, Available-for-Sale [Line Items]    
Amortized Cost $ 0 $ 3,997
Fair Value 0 3,997
Commercial paper and corporate bonds [Member]    
Debt Securities, Available-for-Sale [Line Items]    
Amortized Cost 0 3,997
Fair Value $ 0 $ 3,997
v3.24.4
Supplemental Balance Sheet Information - Components of Inventories, net (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Inventory Disclosure [Abstract]    
Raw materials $ 8,793 $ 8,505
Work-in process 2,268 2,476
Finished products 4,200 4,187
Inventories $ 15,261 $ 15,168
v3.24.4
Supplemental Balance Sheet Information - Summary of Prepaids and Other Current Assets (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Prepaid Expense and Other Assets, Current [Abstract]    
Prepaid expenses and other $ 3,905 $ 2,752
Irish research and development credits receivable 100 108
Prepaids and other $ 4,005 $ 2,860
v3.24.4
Supplemental Balance Sheet Information - Schedule of Intangible Assets (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Intangible Assets [Line Items]    
Definite-lived intangible assets, Accumulated Amortization $ (26,165) $ (26,652)
Definite-lived intangible assets 20,691  
Intangible assets, Gross Carrying Amount 47,436 50,221
Intangible assets, Net $ 21,271 $ 23,569
Customer Lists and Relationships [Member]    
Intangible Assets [Line Items]    
Definite-lived intangible assets, Weighted Average Original Life (Years) 9 years 3 months 18 days 9 years 3 months 18 days
Definite-lived intangible assets, Gross Carrying Amount $ 11,066 $ 11,870
Definite-lived intangible assets, Accumulated Amortization (10,321) (10,844)
Definite-lived intangible assets $ 745 $ 1,026
Developed Technology [Member]    
Intangible Assets [Line Items]    
Definite-lived intangible assets, Weighted Average Original Life (Years) 11 years 10 months 24 days 11 years 10 months 24 days
Definite-lived intangible assets, Gross Carrying Amount $ 33,452 $ 35,433
Definite-lived intangible assets, Accumulated Amortization (14,215) (14,222)
Definite-lived intangible assets $ 19,237 $ 21,211
Patents and Other [Member]    
Intangible Assets [Line Items]    
Definite-lived intangible assets, Weighted Average Original Life (Years) 14 years 10 months 24 days 14 years 10 months 24 days
Definite-lived intangible assets, Gross Carrying Amount $ 2,338 $ 2,338
Definite-lived intangible assets, Accumulated Amortization (1,629) (1,586)
Definite-lived intangible assets 709 752
Definite-Lived Intangible Assets [Member]    
Intangible Assets [Line Items]    
Definite-lived intangible assets, Gross Carrying Amount 46,856 49,641
Definite-lived intangible assets, Accumulated Amortization (26,165) (26,652)
Definite-lived intangible assets 20,691 22,989
Trademarks and Trade Names [Member]    
Intangible Assets [Line Items]    
Indefinite-lived intangible assets, Net $ 580 $ 580
v3.24.4
Supplemental Balance Sheet Information - Additional Information (Detail) - USD ($)
$ in Millions
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Balance Sheet Related Disclosures [Abstract]    
Amortization expense $ 0.9 $ 0.9
v3.24.4
Supplemental Balance Sheet Information - Estimated Amortization Expense (Detail)
$ in Thousands
Dec. 31, 2024
USD ($)
Goodwill and Intangible Assets Disclosure [Abstract]  
Remainder of 2025 $ 2,694
2026 2,741
2027 2,498
2028 2,488
2029 2,488
2030 2,262
Thereafter 5,520
Definite-lived intangible assets $ 20,691
v3.24.4
Supplemental Balance Sheet Information - Schedule of Carrying Amount of Goodwill by Segment (Detail)
$ in Thousands
3 Months Ended
Dec. 31, 2024
USD ($)
Goodwill [Line Items]  
Goodwill as of September 30, 2024 $ 44,640
Currency translation adjustment (2,232)
Goodwill as of December 31, 2024 42,408
In Vitro Diagnostics [Member]  
Goodwill [Line Items]  
Goodwill as of September 30, 2024 8,010
Goodwill as of December 31, 2024 8,010
Medical Device [Member]  
Goodwill [Line Items]  
Goodwill as of September 30, 2024 36,630
Currency translation adjustment (2,232)
Goodwill as of December 31, 2024 $ 34,398
v3.24.4
Supplemental Balance Sheet Information - Summary of Other Noncurrent Assets (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Schedule of Investments [Line Items]    
Contract asset $ 803 $ 689
Other assets, net 4,407 4,093
Operating Lease Right-of-Use Assets [Member]    
Schedule of Investments [Line Items]    
Other assets, net 2,820 3,028
Other [Member]    
Schedule of Investments [Line Items]    
Other assets, net $ 784 $ 376
v3.24.4
Supplemental Balance Sheet Information - Schedule of Accrued Other Liabilities (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Accrued Liabilities, Current [Abstract]    
Accrued professional fees $ 869 $ 563
Accrued clinical study expense 377 499
Accrued purchases 828 1,023
Operating lease liability, current portion $ 1,049 $ 1,040
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] Total accrued other liabilities Total accrued other liabilities
Other $ 459 $ 670
Total accrued other liabilities $ 3,582 $ 3,795
v3.24.4
Supplemental Balance Sheet Information - Schedule of Other Long-term Liabilities (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Other Liabilities Disclosure [Abstract]    
Deferred consideration $ 1,669 $ 1,661
Unrecognized tax benefits 3,263 3,176
Operating lease liabilities, less current portion $ 2,387 $ 2,648
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] Other long-term liabilities Other long-term liabilities
Other $ 281 $ 298
Other long-term liabilities $ 7,600 $ 7,783
v3.24.4
Debt - Schedule of Debt (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Schedule of Debt [Line Items]    
Long-term debt, gross $ 30,000 $ 30,000
Less: Unamortized debt issuance costs (409) (446)
Long-term debt, net 29,591 29,554
Revolving Credit Facility [Member] | Term SOFR [Member]    
Schedule of Debt [Line Items]    
Long-term debt, gross 5,000 5,000
Secured Term Loan Facilities [Member] | Term SOFR [Member] | Tranche 1 [Member]    
Schedule of Debt [Line Items]    
Long-term debt, gross $ 25,000 $ 25,000
v3.24.4
Debt - Schedule of Debt (Parenthetical) (Detail) - Term SOFR [Member]
3 Months Ended
Dec. 31, 2024
Revolving Credit Facility [Member]  
Schedule of Debt [Line Items]  
Description of variable rate basis Term SOFR + 3.00%
Debt instrument, basis spread on variable rate 3.00%
Maturity date Oct. 01, 2027
Secured Term Loan Facilities [Member] | Tranche 1 [Member]  
Schedule of Debt [Line Items]  
Description of variable rate basis Term SOFR +5.75%
Debt instrument, basis spread on variable rate 5.75%
Maturity date Oct. 01, 2027
v3.24.4
Debt - Additional Information (Detail) - USD ($)
3 Months Ended
Oct. 14, 2022
Dec. 31, 2024
Sep. 30, 2024
Line Of Credit Facility [Line Items]      
Secured term loan facilities, proceeds at closing   $ 30,000,000 $ 30,000,000
Secured Overnight Financing Rate [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Debt instrument, basis spread on variable rate 0.10%    
Description of variable rate basis   Term SOFR as published by CME Group Benchmark Administration Limited plus 0.10%  
Term Loans [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Secured term loan facilities, borrowing capacity $ 75,000,000    
Debt instrument, basis spread on variable rate 5.75%    
MidCap Credit Agreement, exit fee 2.50%    
Term Loans [Member] | Tranche 1 [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Secured term loan facilities, borrowing capacity $ 25,000,000    
Secured term loan facilities, proceeds at closing 25,000,000    
Repayments of lines of credit 10,000,000    
Term Loans [Member] | Tranche 1 [Member] | Secured Overnight Financing Rate [Member]      
Line Of Credit Facility [Line Items]      
Debt instrument, basis spread on variable rate   5.75%  
Description of variable rate basis   Term SOFR +5.75%  
Term Loans [Member] | Tranche 2 [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Secured term loan facilities, borrowing capacity 50,000,000    
Secured term loan facilities, proceeds at closing $ 0    
Term Loans [Member] | Year Three to Maturity [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Prepayment penalty 1.00%    
Term Loans [Member] | Minimum [Member] | Secured Overnight Financing Rate [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Debt instrument, variable rate floor 1.50%    
Term Loans [Member] | Midcap Revolving Credit Facility [Member] | Midcap Event of Default [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
MidCap Credit Agreement, interest rate premium upon event of default 2.00%    
Revolving Credit Facility [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Revolving credit facility, maximum borrowing capacity $ 25,000,000    
Debt instrument, basis spread on variable rate 3.00%    
Revolving credit facility, minimum borrowing as percentage of availability 20.00%    
Percentage of annual collateral management fee 0.50%    
Percentage of annual minimum balance fee 0.50%    
Revolving credit facility, unused commitment fee rate 0.50%    
Revolving Credit Facility [Member] | Secured Overnight Financing Rate [Member]      
Line Of Credit Facility [Line Items]      
Debt instrument, basis spread on variable rate   3.00%  
Description of variable rate basis   Term SOFR + 3.00%  
Revolving Credit Facility [Member] | Tranche 1 [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Revolving credit facility, proceeds at closing $ 5,000,000    
Revolving Credit Facility [Member] | Year Two [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Prepayment penalty 1.00%    
Revolving Credit Facility [Member] | Minimum [Member] | Secured Overnight Financing Rate [Member] | MidCap Credit Agreement [Member]      
Line Of Credit Facility [Line Items]      
Debt instrument, variable rate floor 1.50%    
v3.24.4
Derivative Financial Instruments - Schedule of Net Fair Value of Designated Hedge Derivatives Subject to Master Netting Arrangements Reported on Condensed Consolidated Balance Sheets (Detail) - Interest Rate Swap [Member] - USD ($)
$ in Thousands
Dec. 31, 2024
Sep. 30, 2024
Offsetting Assets [Line Items]    
Gross Recognized Amount $ (196) $ (673)
Net Amount Presented (196) (673)
Cash Collateral Receivable 436 625
Net Amount Reported   $ (48)
Net Amount Reported $ 240  
Derivative Asset, Statement of Financial Position [Extensible Enumeration] Other Assets, Noncurrent  
Derivative Liability, Statement of Financial Position [Extensible Enumeration]   Other Liabilities, Noncurrent
v3.24.4
Derivative Financial Instruments - Schedule of Pretax Amounts Recognized in Accumulated Other Comprehensive Loss ("AOCL") for Designated Hedge Derivative Instruments (Detail) - USD ($)
$ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Derivative Instruments, Gain (Loss) [Line Items]    
Beginning unrealized net (loss) gain in AOCL $ (673) $ 183
Net gain (loss) recognized in other comprehensive (loss) income 506 (620)
Net gain (loss) reclassified into interest expense $ (29) $ (62)
Derivative Instrument, Gain (Loss) Reclassified from AOCI into Income, Effective Portion, Statement of Income or Comprehensive Income [Extensible Enumeration] Other Comprehensive Income (Loss), Derivative, Excluded Component, Increase (Decrease), Adjustments, after Tax Other Comprehensive Income (Loss), Derivative, Excluded Component, Increase (Decrease), Adjustments, after Tax
Ending unrealized (loss) gain in AOCL $ (196) $ (499)
v3.24.4
Stock-based Compensation Plans - Stock-based Compensation Expenses (Detail) - USD ($)
$ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]    
Stock-based compensation expense $ 1,743 $ 1,968
Product costs [Member]    
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]    
Stock-based compensation expense 59 72
Research and development [Member]    
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]    
Stock-based compensation expense 301 370
Selling, general and administrative [Member]    
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]    
Stock-based compensation expense $ 1,383 $ 1,526
v3.24.4
Stock-based Compensation Plans - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Millions
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Stock-Based Compensation Activity [Line Items]    
Unrecognized compensation costs, nonvested awards, amount $ 9.1  
Unrecognized compensation costs, nonvested awards, weighted average recognition period 2 years  
Restricted Stock Awards [Member]    
Stock-Based Compensation Activity [Line Items]    
Units granted 0 98,000
Weighted average grant date fair value   $ 33.64
Restricted Stock Units (RSUs) [Member]    
Stock-Based Compensation Activity [Line Items]    
Units granted 0 5,000
Weighted average grant date fair value   $ 33.64
1999 Employee Stock Purchase Plan [Member]    
Stock-Based Compensation Activity [Line Items]    
Shares issued 0 0
v3.24.4
Stock-based Compensation Plans - Summary of Stock Option Grant Activity (Detail) - Stock Option Awards [Member]
3 Months Ended
Dec. 31, 2023
$ / shares
shares
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]  
Stock options granted | shares 250,000
Weighted average grant date fair value $ 15.82
Weighted average exercise price $ 33.64
v3.24.4
Net (Loss) Income Per Share Data - Additional Information (Detail) - shares
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Maximum [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive options excluded from computation of EPS 100,000 100,000
v3.24.4
Net (Loss) Income Per Share Data - Basic and Diluted Weighted Average Shares Outstanding (Detail) - shares
shares in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Earnings Per Share [Abstract]    
Basic weighted average shares outstanding 14,231 14,102
Diluted weighted average shares outstanding 14,231 14,102
v3.24.4
Income Taxes - Additional Information (Detail) - USD ($)
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Sep. 30, 2024
Income Tax Disclosure [Line Items]      
Income tax expense $ (707,000) $ (62,000)  
U.S. federal statutory tax rate 21.00%    
Valuation allowance percentage 50.00%    
Unrecognized tax benefits excluding interest and penalties that would impact effective tax rate $ 3,200,000   $ 2,800,000
Undistributed earnings in foreign subsidiaries 0   $ 0
Maximum [Member]      
Income Tax Disclosure [Line Items]      
Discrete tax benefits related to stock-based compensation awards $ 100,000 $ 100,000  
v3.24.4
Commitments and Contingencies - Additional Information (Detail) - USD ($)
$ in Millions
3 Months Ended 12 Months Ended 24 Months Ended
Sep. 30, 2027
Dec. 31, 2024
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2020
Sep. 30, 2018
Sep. 30, 2024
Vetex Medical Limited [Member]                
Commitments And Contingencies [Line Items]                
Payments to acquire in-process research and development   $ 1.8            
Consideration paid at closing         $ 39.9      
Contingent consideration, contractual value         $ 3.5      
Contingency period ending year         2027      
Forecast [Member] | Vetex Medical Limited [Member]                
Commitments And Contingencies [Line Items]                
Deferred consideration, contractual value $ 1.8              
Embolitech LLC [Member]                
Commitments And Contingencies [Line Items]                
Contingent payments upon achievement of regulatory milestones   $ 1.0            
Installment payment period   2024            
In-Process Research and Development [Member] | Embolitech LLC [Member]                
Commitments And Contingencies [Line Items]                
Contingency period ending year   2033            
Payments to acquire in-process research and development     $ 1.0 $ 0.5 $ 1.0 $ 1.0 $ 5.0  
Contractual obligation payable in fiscal 2022 through fiscal 2024               $ 0.9
v3.24.4
Segment Information - Segment Revenue, Operating (Loss) Income and Depreciation and Amortization (Detail) - USD ($)
$ in Thousands
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Segment Reporting Information [Line Items]    
Revenue $ 29,922 $ 30,552
Total operating (loss) income (2,481) (322)
Depreciation and amortization 2,083 2,333
Operating Segments [Member]    
Segment Reporting Information [Line Items]    
Revenue 29,922 30,552
Total operating (loss) income 3,083 2,900
Operating Segments [Member] | Medical Device [Member]    
Segment Reporting Information [Line Items]    
Revenue 23,281 23,545
Total operating (loss) income 161 (224)
Depreciation and amortization 1,924 2,054
Operating Segments [Member] | In Vitro Diagnostics [Member]    
Segment Reporting Information [Line Items]    
Revenue 6,641 7,007
Total operating (loss) income 2,922 3,124
Depreciation and amortization 91 97
Corporate [Member]    
Segment Reporting Information [Line Items]    
Total operating (loss) income (5,564) (3,222)
Depreciation and amortization $ 68 $ 182
v3.24.4
Merger Agreement - Additional Information (Detail) - GTCR Merger Agreement [Member] - USD ($)
$ / shares in Units, $ in Millions
3 Months Ended
May 28, 2024
Dec. 31, 2024
Business Combinations [Line Items]    
Merger consideration $ 43  
Merger related charges   $ 2.3
Termination fee payable $ 20.4  
Minimum [Member]    
Business Combinations [Line Items]    
Reverse termination fee under specified circumstances 50.2  
Maximum [Member]    
Business Combinations [Line Items]    
Reverse termination fee under other circumstances $ 47.0  

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