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 June 30, 2022 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) Indicate by check mark whether the registrant is a large accelerated filer, an acceler ...

1 | --- | --- | --- | |---------------------------------------------------------|-------|-------| | | | | | | | | | Gary Maharaj President and CEO | | | | Tim Arens | | | | Senior Vice President of Finance, IT and CFO April 2022 | | | © 2022 Surmodics, Inc. CONFIDENTIAL All rights reserved. 2 Safe Harbor Some of the statements made during this presentation may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historic ...

Surmodics, Inc. (NASDAQ:SRDX) Q2 2022 Earnings Conference Call April 27, 2022 8:30 AM ET Company Participants Tim Arens - SVP, Finance & CFO Gary Maharaj - President & CEO Conference Call Participants David Saxon - Needham Brooks O'Neil - Lake Street Capital Markets Jim Sidoti - Sidoti & Company Mike Petusky - Barrington Research Operator Good day, and welcome to the Surmodics Second Quarter Fiscal 2022 Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference ...

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 March 31, 2022 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 9924 West 74th Street, Eden Prairie, Minnesota 55344 (Address of ...

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, 2021 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) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Id ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2022 increased by 3% to $23 million compared to $22.3 million in the prior year quarter, driven by solid performance from both Medical Device and In Vitro Diagnostics businesses [10][39] - GAAP diluted loss per share was negative $0.20, while non-GAAP diluted loss per share was negative $0.13 [10][55] - Royalty and license fee revenue totaled $8.1 million, down $1.2 million from the prior year, with royalty revenue declining 13% to $6.9 million [41][55] Business Line Data and Key Metrics Changes - Medical Device business revenue grew 4% year-over-year to $16.9 million, driven by strong product sales [39] - In Vitro Diagnostics business revenue was essentially flat at $6.1 million, with growth in stabilization and colorimetric substrate products offset by a decline in slide product revenue [40][47] - Product revenue in the Medical Device business increased by 22% to $12.3 million, with a 49% growth in product revenue specifically driven by increased demand for coating reagents and medical devices [45][47] Market Data and Key Metrics Changes - The company faced challenges due to COVID-19, including elective procedure delays and staffing shortages impacting both suppliers and internal operations [8][9] - The company estimates that more than half of its royalty revenues are associated with devices used in elective or moderately urgent procedures, which have been deferred due to the pandemic [37] Company Strategy and Development Direction - The company aims to achieve PMA for SurVeil and support Abbott's commercialization efforts, while also focusing on becoming a first-line treatment for patients with its Sublime Radial platform [11][12] - The company is prioritizing the commercialization of its Sublime and Pounce platforms, with a focus on building a robust sales pipeline and increasing market awareness [19][28] - The company plans to continue investing in its commercialization pipeline to drive consistent double-digit revenue growth beginning in fiscal 2023 [29][33] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about achieving fiscal 2022 financial and strategic objectives despite recent headwinds from COVID-19 [9] - The company reaffirms its fiscal 2022 guidance, expecting revenue to range from $97 million to $101 million, with GAAP EPS losses projected between $2.05 and $1.55 [58] - Management anticipates sequential revenue growth in Q2 2022 compared to Q1, assuming the current COVID wave subsides [83] Other Important Information - The company reported a product gross margin of 64%, an increase from 63% in the prior year quarter, with improved margins in both Medical Device and IVD businesses [49] - R&D expenses increased to $11.7 million, representing 51% of revenue, driven by investments in Pounce venous thrombectomy device readiness [50][51] - The company expects to finish the year with approximately $20 million in cash, excluding potential milestone payments [57] Q&A Session Summary Question: Will Q2 results be lower than Q1 due to market headwinds? - Management indicated that Q2 results will likely be influenced by a significant milestone payment recognized in the prior year, but they expect year-on-year revenue growth overall [62][63] Question: Has the success with Sublime and Pounce changed the long-term strategy regarding partnerships? - Management expressed caution, emphasizing the importance of early market validation and the competitive nature of the market for sales personnel [64][65] Question: What is the timeline for SurVeil's FDA approval and commercialization? - Management outlined that after a pre-submission meeting in late April, a 90-day review period would follow, with potential approval expected in the second half of 2022 [81][82] Question: Why is additional analysis requested for Sundance? - The Steering Committee requested further analysis to ensure adherence to trial protocols, not due to safety concerns [72][74] Question: How will revenue be recognized once SurVeil is approved? - Revenue will be recognized from product sales and profit sharing, with more details to be provided as the situation develops [99]

1 | --- | --- | |-----------------------------------------------------------|-------| | | | | | | | Gary Maharaj President and CEO | | | Tim Arens | | | Senior Vice President of Finance, IT and CFO January 2022 | | © 2022 Surmodics, Inc. CONFIDENTIAL All rights reserved. 2 Safe Harbor Some of the statements made during this presentation may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical or current facts, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 0-23837 Surmodics, Inc. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorpo ...

Financial Data and Key Metrics Changes - For fiscal year 2021, the company generated $105.1 million in revenue, an increase of 11% from $94.9 million in fiscal 2020, driven by growth in both medical device and in vitro diagnostic businesses, which grew 10% and 15% respectively [8][9] - The company reported GAAP diluted earnings per share of $0.30 for the full year, benefiting from a $3.6 million reimbursement associated with the CARES Act, which positively impacted earnings per share by $0.19 [10] - In Q4 fiscal 2021, revenues grew 6% to $24 million compared to $22.5 million in the prior year quarter, with the Medical Device business revenue growing 1% to $17.4 million and the In Vitro Diagnostics business growing 23% to $6.6 million [39] Business Line Data and Key Metrics Changes - The Medical Device business reported product revenue of $6.3 million in Q4, an 18% increase from $5.4 million in the prior year quarter, driven by strong coating reagent sales and new product launches [42] - The In Vitro Diagnostics business reported product revenue of $6.2 million, up 19% compared to the same prior year period, benefiting from increased demand for antigen products [43] - R&D services revenue increased by 24% to $2.6 million, reflecting increased customer development programs leveraging medical coatings [44] Market Data and Key Metrics Changes - The IVD business is expected to outperform the immunoassay market growth of 3%, while medical device coatings revenue is expected to grow low to mid-single digits, in line with the endovascular device market [38] Company Strategy and Development Direction - The company aims to achieve PMA approval for SurVeil and support Abbott's commercialization efforts, while also focusing on becoming the first-line treatment for patients with the Sublime radial platform and Pounce thrombectomy systems [27][28] - The company plans to build a small commercial team to drive customer adoption and demonstrate the commercial viability of its products, with an investment of approximately $10 million to support initial commercialization efforts [35][36] - The company is strategically holding off on deep negotiations with larger companies to maximize shareholder value from its innovative products [81] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by the FDA's evolving requirements for long-term mortality data, which have shifted the approval process for SurVeil [60][62] - The company remains optimistic about its product pipeline and the potential for significant value creation, emphasizing the importance of demonstrating commercial viability in the market [69][92] - The outlook for fiscal 2022 anticipates revenue between $97 million and $101 million, with expectations for growth in legacy businesses and new product introductions [54][90] Other Important Information - The company faced ongoing supply chain issues affecting key components required for validation devices, which could delay timelines [25] - The company reported a loss per share of $0.02 in Q4 fiscal 2021, compared to a loss of $0.22 in the prior year quarter, with non-GAAP EPS showing a similar trend [52] Q&A Session Summary Question: Can you comment on the competitive landscape for SurVeil? - Management noted that the FDA's requirements have shifted, creating a more challenging environment compared to competitors with less stringent data requirements [60][63] Question: Is the company confident in its ability to go it alone in commercialization? - Management expressed confidence in their capabilities to demonstrate commercial value and maximize shareholder returns by building a small sales team [68][81] Question: What is the rationale behind building a direct sales force? - The decision to build a sales force is based on the desire to capture the full value of their products and respond to physician demand for continued use of their devices [83][84] Question: How does the revenue guidance for 2022 compare to 2021? - Management clarified that the guidance reflects a normalization of revenue, excluding one-time items from 2021, indicating solid growth in legacy businesses [89][90]

| --- | --- | --- | |--------------------------------------------------------|-------|-------| | | | | | | | | | | | | | Gary Maharaj President and CEO | | | | Tim Arens Senior Vice President of Finance, IT and CFO | | | | AUGUST 2021 | | | © 2021 Surmodics, Inc. CONFIDENTIAL All rights reserved. SAFE HARBOR Some of the statements made during this presentation may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not hist ...