Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today announced results for its fiscal 2022 first quarter ended December 31, 2021.

Summary of First Quarter and Recent Highlights

• Revenue of $23.0 million, an increase of 3% year-over-year
• GAAP EPS of $(0.20), non-GAAP EPS of $(0.13)
• First commercial sale of Pounce™ Arterial Thrombo-embolectomy System

“I am pleased with our first quarter performance. We delivered revenue growth and made critical progress on our SurVeil™ drug-coated balloon PMA submission and early commercialization of our Sublime™ radial and Pounce™ arterial thrombectomy platforms,” said Gary Maharaj, President and CEO of Surmodics, Inc. “I’m optimistic about our ability to deliver on our key strategic objectives this fiscal year.”

First Quarter Fiscal 2022 Financial Results

Total revenue for the first quarter of fiscal 2022 was $23.0 million, compared to $22.3 million in the prior-year period. Medical Device revenue was $16.9 million for the first quarter of fiscal 2022, compared to $16.2 million for the prior-year period, an increase of 4%. Medical Device revenue in the first quarter of fiscal 2022 includes $1.2 million from our Development and Distribution Agreement with Abbott Vascular, Inc. (“Abbott”) for the SurVeil drug-coated balloon, compared to $1.3 million in the prior-year quarter. In Vitro Diagnostics revenue was $6.1 million for both the first quarter of fiscal 2022 and 2021.

Diluted GAAP earnings per share in the first quarter of fiscal 2022 was a loss per share of $(0.20), compared to a loss per share of $(0.02) in the same prior-year period. On a non-GAAP basis, loss per share in the first quarter of fiscal 2022 was $(0.13), compared to earnings per share of $0.02 in the same prior-year quarter.

As of December 31, 2021, Surmodics reported cash and investments totaling $32.3 million and $10 million in outstanding borrowings on its $25 million line of credit. Surmodics reported $7.0 million of cash used in operating activities and $0.8 million in capital expenditures in the first quarter of fiscal 2022.

Company Reiterates Fiscal 2022 Guidance

Surmodics expects fiscal year 2022 revenue to range from $97 million to $101 million. The Company expects fiscal 2022 diluted GAAP EPS to range from a loss per share of $(2.05) to $(1.55), which reflects increased investments to accelerate the Company’s strategy. Non-GAAP diluted EPS for fiscal 2022 is expected to range from a loss per share of $(1.75) to $(1.25).

Surmodics has the potential to receive a $30 million milestone payment during fiscal 2022 or fiscal 2023 related to premarket approval of the SurVeil DCB pursuant to the Abbott Development and Distribution Agreement. The potential revenue associated with this milestone payment would be approximately $25 million. As has been the Company’s practice with past guidance, revenue from regulatory-related milestones is not included in guidance until they are achieved.

Conference Call Today at 7:30 a.m. CT (8:30 a.m. ET)

Surmodics is hosting a webcast at 7:30 a.m. CT (8:30 a.m. ET) today to discuss first quarter results. To access the webcast, go to the investor relations portion of the Company’s website at https://surmodics.gcs-web.com and click on the webcast icon. The webcast will be archived on the Company’s website for 90 days. A replay of the first quarter conference call will be available by dialing 888-203-1112 and entering conference call ID passcode 5657051. The audio replay will be available beginning at 10:30 a.m. CT on Thursday, February 3, 2022, until 10:30 a.m. CT on Thursday, February 10, 2022.

About Surmodics, Inc.

Surmodics is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing development and commercialization of highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development, and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the Company makes with the Securities and Exchange Commission (“SEC”).

Safe Harbor for Forward-looking Statements

This press release, and disclosures related to it, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical or current facts, including statements regarding our fiscal 2022 strategic objectives and our ability to deliver on our fiscal 2022 financial and strategic objectives; our revenue and loss expectations for fiscal 2022 and beyond, including our fiscal 2022 financial guidance; expectations regarding the duration of factors impacting our royalty revenues and the return to growth of royalty revenues; expectations regarding medical device product revenue growth; expectations regarding design verification, process validation, and manufacturing validation related to the Company’s products; the potential for the commercial success or our products; expectations regarding actions related to the U.S. Food and Drug Administration’s (“FDA”) review of the premarket approval application for, and the potential FDA approval of, our SurVeil DCB; the potential receipt of a premarket approval milestone payment from Abbott; the expected timing of completion and delivery of the SWING first-in-human clinical trial results; the Company’s strategy; plans for clinical product evaluations; expectations regarding revenue from our Sublime and Pounce product portfolios; expectations regarding the return to growth of our In Vitro Diagnostics business and its level of growth for fiscal 2022; expectations regarding fiscal 2022 operating expenses; and our anticipated fiscal 2022 year-end cash balance, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including, without limitation: (1) our ability to successfully develop and commercialize our SurVeil DCB (including realization of the full potential benefits of our agreement with Abbott), Avess™ DCB, Sundance™ DCB, and other proprietary products; (2) whether and when the FDA grants premarket approval to the SurVeil DCB; (3) our reliance on third parties (including our customers and licensees) and their failure to successfully develop, obtain regulatory approval for, market, and sell products incorporating our technologies; (4) possible adverse market conditions and possible adverse impacts on our cash flows; (5) the impacts, duration, and severity of the global COVID-19 pandemic and the effects of responses to it on healthcare systems, the general economy, our business partners, and our operations; (6) our ability to integrate the acquisition of Vetex Medical Limited successfully and realize the anticipated benefits of the acquisition; (7) whether anticipated increases in our operating expenses are effective in generating profitable revenues; and (8) the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2021 and subsequent SEC filings. These reports are available in the Investors section of our website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.

Use of Non-GAAP Financial Information

In addition to reporting financial results in accordance with U.S. generally accepted accounting principles, or GAAP, Surmodics is reporting non-GAAP financial results including EBITDA and Adjusted EBITDA, non-GAAP operating (loss) income, non-GAAP operating (loss) income percentage, non-GAAP (loss) income before income taxes, non-GAAP net (loss) income, non-GAAP diluted (loss) earnings per share, and the non-GAAP effective income tax rate. We believe that these non-GAAP measures, when read in conjunction with the Company’s GAAP financial statements, provide meaningful insight into our operating performance excluding certain event-specific matters, and provide an alternative perspective of our results of operations. We use non-GAAP measures, including those set forth in this release, to assess our operating performance and to determine payouts under our executive compensation programs. We also are providing guidance on a range of non-GAAP diluted loss per share for fiscal 2022. We believe that presentation of certain non-GAAP measures allows investors to review our results of operations from the same perspective as management and our board of directors and facilitates comparisons of our current results of operations. The method we use to produce non-GAAP results is not in accordance with GAAP and may differ from the methods used by other companies. Non-GAAP results should not be regarded as a substitute for corresponding GAAP measures but instead should be utilized as a supplemental measure of operating performance in evaluating our business. Non-GAAP measures do have limitations in that they do not reflect certain items that may have a material impact on our reported financial results. As such, these non-GAAP measures should be viewed in conjunction with both our financial statements prepared in accordance with GAAP and the reconciliation of the supplemental non-GAAP financial measures to the comparable GAAP results provided for the specific periods presented, which are attached to this release.

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