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Surmodics Inc (SRDX) SEC Filing 10-K Annual Report for the fiscal year ending Friday, September 30, 2022

Surmodics Inc

CIK: 924717 Ticker: SRDX

 

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EXHIBIT 99.1

 

Surmodics Reports Fourth Quarter and Fiscal Year 2022 Financial Results;

Introduces Fiscal Year 2023 Financial Guidance

November 9, 2022 07:00 Eastern Standard Time

EDEN PRAIRIE, Minn. – Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today reported financial results for its fourth quarter and fiscal year ended September 30, 2022, and introduced its financial outlook for the fiscal year ending September 30, 2023.

Fourth Quarter 2022 Financial Summary

Total Revenue of $26.0 million, an increase of 8% year-over-year
GAAP Diluted EPS of $(1.06), including $(0.73) deferred tax valuation reserve, compared to $(0.02) in the prior-year period
Non-GAAP Diluted EPS of $(0.26), compared to $(0.10) in the prior-year period

Fiscal Year 2022 Financial Summary

Total Revenue of $100.0 million, a decrease of 5% year-over-year
GAAP Diluted EPS of $(1.96), including $(0.73) deferred tax valuation reserve, compared to $0.30 in the prior-year period
Non-GAAP Diluted EPS of $(0.95), compared to $0.37 in the prior-year period

Business Highlights

On October 11, 2022, Surmodics announced that six-month data from its SWING first-in-human study of the Company’s Sundance™ Sirolimus drug-coated balloon was presented at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland, with Sundance demonstrating an excellent safety profile and the lowest binary restenosis at six months, compared to relevant below-the-knee trials.
On October 13, 2022, Surmodics submitted a complete response to FDA comments on its application for premarket approval of the SurVeil™ drug-coated balloon.
On October 17, 2022, Surmodics announced that it has entered into a new, five-year credit agreement with MidCap Financial, consisting of up to $100 million in term loans and a $25 million revolving credit facility.
On November 2, 2022, Surmodics announced that 24-month data from its TRANSCEND clinical trial of the Company’s SurVeil™ drug-coated balloon was presented at the Vascular InterVentional Advances (VIVA) annual conference in Las Vegas, Nevada, with SurVeil demonstrating sustained durability of safety and efficacy endpoints.

“We are pleased to bring fiscal 2022 to a strong conclusion, delivering revenue performance that exceeded our expectations for the fourth quarter, while continuing to invest in our business and make progress on our strategic objectives,” said Gary Maharaj, President and CEO of Surmodics, Inc. “Our fourth quarter revenue performance was exclusively driven by Medical Device revenue, which increased 12% year-over-year, with stronger-than-anticipated product sales – including sales of our Pounce™ and Sublime™ products – and licensing fee revenue. From an operational standpoint, our regulatory team worked diligently to prepare a complete response to FDA comments on the PMA application for our SurVeil drug-coated balloon, which we are pleased to announce was submitted to the Agency on October 13th. We also made important progress with respect to the initial commercialization of our Pounce arterial thrombectomy and Sublime radial platforms, onboarding and training our recently hired territory managers, building our customer base, and generating early commercial traction.”

 


The following information was filed by Surmodics Inc (SRDX) on Wednesday, November 9, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Surmodics Inc's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Comprehensive (Loss) Income
Consolidated Statements Of Operations
Consolidated Statements Of Stockholders' Equity
Acquisitions
Acquisitions (Tables)
Acquisitions - Additional Information (Detail)
Acquisitions - Summary Of Acquisition Date Fair Value Of Purchase Consideration (Detail)
Acquisitions - Summary Of Final Allocation Of Purchase Consideration As Of Acquisition Date (Detail)
Collaborative Arrangement
Collaborative Arrangement - Additional Information (Detail 1)
Collaborative Arrangement - Additional Information (Detail)
Commitments And Contingencies
Commitments And Contingencies - Additional Information (Detail)
Debt
Debt - Additional Information (Details)
Defined Contribution Plans
Defined Contribution Plans - Additional Information (Detail)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Fair Value Measurements - Schedule Of Contingent Consideration Liabilities Measured At Fair Value (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Schedule Of Deferred Income Taxes, Net (Detail)
Income Taxes - Schedule Of Deferred Income Taxes, Net (Parenthetical) (Details)
Income Taxes - Schedule Of Income Taxes (Detail)
Income Taxes - Schedule Of Reconciliation Difference Of Income Taxes (Detail)
Income Taxes - Schedule Of Reconciliation Difference Of Income Taxes (Parenthetical) (Details)
Income Taxes - Summary Of Reconciliation Of Changes In Unrecognized Tax Benefits (Detail)
Organization
Reportable Segment Information
Reportable Segment Information (Tables)
Reportable Segment Information - Additional Information (Detail)
Reportable Segment Information - Geographic Revenue And Long-Lived Assets (Detail)
Reportable Segment Information - Segment Revenue, Operating (Loss) Income And Depreciation And Amortization (Detail)
Revenue
Revenue (Tables)
Revenue - Additional Information (Detail)
Revenue - Revenue From Customers (Detail)
Revenue - Summary Of Disaggregation Of Revenue Within Reportable Segment (Detail)
Schedule Of Valuation And Qualifying Accounts
Schedule Of Valuation And Qualifying Accounts - Valuation And Qualifying Accounts (Detail)
Stock-Based Compensation Plans
Stock-Based Compensation Plans (Tables)
Stock-Based Compensation Plans - Additional Information (Detail)
Stock-Based Compensation Plans - Schedule Of Restricted Stock Activity (Detail)
Stock-Based Compensation Plans - Schedule Of Stock Option Activity (Detail)
Stock-Based Compensation Plans - Stock Option Fair Value Assumptions And Weighted Average Fair Value Of Stock Options Granted (Detail)
Stock-Based Compensation Plans - Stock-Based Compensation Expenses (Detail)
Stockholders' Equity
Stockholders' Equity - Additional Information (Detail)
Subsequent Events
Subsequent Events - Additional Information (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information
Summary Of Significant Accounting Policies And Select Balance Sheet Information (Policies)
Summary Of Significant Accounting Policies And Select Balance Sheet Information (Tables)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Additional Information (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Amortized Cost, Unrealized Holding Gains And (Losses) And Fair Value Of Available-For-Sale Securities (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Balance Sheet Classification And Amounts Of Right-Of-Use Assets And Lease Liabilities (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Components Of Inventories (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Denominator For Computation Of Diluted Weighted Average Shares Outstanding (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Estimated Amortization Expense (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Schedule Of Accrued Other Liabilities (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Schedule Of Carrying Amount Of Goodwill By Reportable Segment (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Schedule Of Intangible Assets (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Schedule Of Operating Lease Maturities (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Schedule Of Other Long-Term Liabilities (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Schedule Of Property, Plant And Equipment (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Summary Of Other Noncurrent Assets (Detail)
Summary Of Significant Accounting Policies And Select Balance Sheet Information - Summary Of Prepaids And Other Current Assets (Detail)
Ticker: SRDX
CIK: 924717
Form Type: 10-K Annual Report
Accession Number: 0000950170-22-025644
Submitted to the SEC: Wed Nov 23 2022 8:55:51 AM EST
Accepted by the SEC: Wed Nov 23 2022
Period: Friday, September 30, 2022
Industry: Surgical And Medical Instruments And Apparatus

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