Recent Quotes View Full List My Watchlist Create Watchlist Indicators DJI Nasdaq Composite SPX Gold Crude Oil Hydroworld Market Index Markets Stocks ETFs Tools Overview News Currencies International Treasuries Surmodics Reports Third Quarter of Fiscal Year 2023 Financial Results; Updates Fiscal Year 2023 Financial Guidance By: Surmodics, Inc. via Business Wire August 02, 2023 at 07:31 AM EDT 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 third quarter ended June 30, 2023, and updated its financial guidance for its fiscal year ending September 30, 2023. Third Quarter Fiscal 2023 Financial Summary Total Revenue of $52.5 million, an increase of 111% year-over-year Recognized $24.6 million in license fee revenue upon receipt of a $27.0 million milestone payment associated with obtaining FDA premarket approval of the SurVeil™ DCB under the company’s Development and Distribution Agreement with Abbott GAAP Diluted EPS of $0.52, compared to $(0.41) in the prior-year period Non-GAAP Diluted EPS of $0.52, compared to $(0.34) in the prior-year period Third Quarter and Recent Business Highlights On April 19, 2023, Surmodics announced the first successful patient use of the Sublime™ radial access microcatheter, the industry’s first suite of torqueable peripheral microcatheters, designed for navigating tortuosity and crossing complex lesions and available for both transradial and transfemoral procedures. On April 20, 2023, Surmodics announced enrollment of the first patient in PROWL, the Pounce™ Thrombectomy System Retrospective Registry, to collect real-world efficacy and safety outcomes data for endovascular interventions using the Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. On June 14, 2023, Surmodics announced the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System, which will allow for efficient clot removal in below-the-knee peripheral arteries (2 mm to 4 mm in diameter), expanding the addressable market for the Pounce platform. On June 20, 2023, Surmodics announced the receipt of FDA premarket approval for its SurVeil™ drug-coated balloon (DCB). The SurVeil DCB may now be marketed and sold in the U.S. by the company’s exclusive distribution partner, Abbott Vascular, Inc. (Abbott). The SurVeil DCB is a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease, includes a proprietary drug-excipient formulation for a durable balloon coating, and is manufactured using an innovative process to improve coating uniformity. “Our third quarter was marked by a combination of strong financial performance – including total revenue growth of 111% year-over-year – and notable progress with respect to our key strategic objectives for fiscal 2023,” said Gary Maharaj, President and CEO of Surmodics, Inc. “Most importantly, we obtained FDA premarket approval for the SurVeil DCB, our next-generation drug-coated balloon, secured a related $27 million milestone payment to strengthen our balance sheet, and made progress in preparing to support its commercial launch. In addition, we expanded the commercial adoption and utilization of our Pounce arterial thrombectomy and Sublime radial access platforms, while advancing our pipeline of additional vascular intervention technologies: secured FDA 510(k) clearance for our Pounce LP Thrombectomy System, initiated the limited market evaluation of our Sublime radial access microcatheter, and continued the limited market evaluation of our Pounce Venous Thrombectomy System.” Mr. Maharaj continued, “Our impressive total revenue performance in the quarter was driven by 163% growth year-over-year in our Medical Device segment, which benefited from the aforementioned milestone payment, along with strong underlying performance – including product sales growth of 38% year-over-year fueled primarily by sales of our Pounce and Sublime products. Lastly, we made notable year-over-year improvements in our profitability profile from an operating income and adjusted EBITDA standpoint, while continuing to control our expenses and manage our cash use. Our increased guidance reflects our impressive financial and operational performance in the third quarter and latest expectations for the balance of the year. Looking ahead, we remain focused on bringing fiscal 2023 to a strong conclusion by continuing to execute against our stated strategic objectives, laying the groundwork for further growth and value creation in the years to come.” Third Quarter Fiscal 2023 Financial Results Three Months Ended June 30, Increase (Decrease) 2023 2022 $ % Revenue: Medical Device $ 46,014 $ 17,528 $ 28,486 163 % In Vitro Diagnostics 6,469 7,326 (857 ) (12 )% Total revenue $ 52,483 $ 24,854 $ 27,629 111 % Total revenue increased $27.6 million, or 111%, to $52.5 million, compared to $24.9 million in the third quarter of fiscal 2022. Medical Device revenue increased $28.5 million, or 163%, to $46.0 million, compared to $17.5 million in the third quarter of fiscal 2022. Medical Device revenue in the third quarter of fiscal 2023 included a total of $25.9 million in license fee revenue from the company’s Development and Distribution Agreement with Abbott for the SurVeil DCB – of which $24.6 million was revenue recognized on the $27.0 million milestone payment received in the period associated with obtaining FDA approval of the SurVeil DCB – compared to $1.0 million of total license fee revenue in the prior-year period. Medical Device revenue growth was broad-based, including significant contributions from Pounce thrombectomy and Sublime radial access device platforms, as well as increased sales of performance coating reagents. In Vitro Diagnostics (“IVD”) revenue decreased $0.9 million, or 12%, to $6.5 million, compared to $7.3 million in the third quarter of fiscal 2022, driven primarily by active management of inventory levels by certain customers. Product gross profit (defined as product sales less product costs) was $8.7 million and was unchanged compared to the third quarter of fiscal 2022. Product gross margin (defined as product gross profit as a percentage of product sales) was 55.8%, compared to 63.1% in the third quarter of fiscal 2022. The decline in product gross margin was primarily driven by the adverse mix impact from increased device product sales, which have lower product gross margins due to low production volumes during the scale-up phase following initial commercialization. Operating costs and expenses, excluding product costs, decreased $2.7 million, or 10%, to $24.2 million, compared to $26.9 million in the third quarter of fiscal 2022. The decrease was driven primarily by lower research and development expenses as the result of the spending reduction plan implemented in the second quarter of fiscal 2023. In addition, operating costs and expenses in the third quarter of fiscal 2023 included a $0.8 million gain from the fair value adjustment of acquisition-related contingent consideration. GAAP net income was $7.3 million, or $0.52 per diluted share, compared to GAAP net loss of $(5.7) million, or $(0.41) per diluted share in the third quarter of fiscal 2022. Non-GAAP net income was $7.3 million, or $0.52 per diluted share, compared to Non-GAAP net loss of $(4.7) million, or $(0.34) per diluted share in the third quarter of fiscal 2022. Adjusted EBITDA was $24.6 million, compared to Adjusted EBITDA loss of $(3.1) million in the third quarter of fiscal 2022. Balance Sheet Summary As of June 30, 2023, Surmodics reported $44.6 million in cash and cash equivalents, $5.0 million in outstanding borrowings on its $25.0 million revolving credit facility, and $25.0 million in outstanding borrowings on its term loan facility. Additional draws on the term loan facility may be made in $10.0 million minimum increments, up to a total of $75.0 million through December 31, 2024. A third tranche of up to $25.0 million on the term loan facility may be available through December 31, 2024 at the lender’s option. Surmodics reported $25.9 million of cash provided by operating activities and $0.5 million in capital expenditures in the third quarter of fiscal 2023. Fiscal Year 2023 Financial Guidance Surmodics now expects fiscal year 2023 total revenue to range from $130 million to $132 million, representing an increase of 30% to 32% compared to the prior year. The company’s prior guidance called for fiscal year 2023 total revenue of $103 million to $106 million, representing an increase of 3% to 6% compared to the prior year. The company now expects fiscal 2023 GAAP diluted loss per share to range from $(0.55) to $(0.40). The company’s prior guidance called for fiscal 2023 GAAP diluted loss per share of $(2.30) to $(2.00). Non-GAAP diluted loss per share in fiscal 2023 is expected to range from $(0.29) to $(0.14). The company’s prior guidance called for fiscal 2023 Non-GAAP diluted loss per share of $(1.98) to $(1.68). Conference Call Today at 7:00 a.m. CT (8:00 a.m. ET) Surmodics is hosting a live webcast at 7:00 a.m. CT (8:00 a.m. ET) today to discuss third quarter of fiscal 2023 financial results and accomplishments, and to host a question-and-answer session. To access the webcast, please go to “Events & Presentations” under the “Investors” section of the company’s website at https://surmodics.gcs-web.com/events-and-presentations, and click on the webcast icon under “Upcoming Events.” To listen to the live teleconference, dial 877-407-8293 (international callers may dial 201-689-8349) and provide access ID: 13739898. An audio replay of the conference call will be available beginning at 11:00 a.m. CT today, until 11:00 a.m. CT on Wednesday, August 16, and can be accessed by dialing 877-660-6853 (international callers may dial 201-612-7415) and entering access ID: 13739898. In addition, the webcast and transcript will be archived on the company’s website following the call. About Surmodics, Inc. Surmodics, Inc. is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also 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. 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: expectations of the timing of an initial stocking order for SurVeil DCB products and of Abbott’s commercialization of the product; being well positioned to support Abbott’s commercial launch of the SurVeil DCB; our belief that the SurVeil DCB will complement and enhance Abbott’s existing product portfolio; our expectation about working with the FDA to update the SurVeil DCB product labeling to reflect currently available paclitaxel data; our future prospects; the expected customer base for our Sublime radial and Pounce arterial thrombectomy platforms by year end and their expected year-over-year growth rate for full fiscal 2023; our expectations regarding expanding the addressable market for our Pounce arterial thrombectomy system with the addition of new products and clinical indications; expectations regarding the conduct and timing of limited market introductions of certain products and of commercialization of products; our expectations related to the PROWL U.S. registry study and expectation of sharing interim data therefrom; our fiscal 2023 financial guidance and related assumptions, including assumptions in our revenue guidance provided for modeling purposes, expected revenue growth rates, expected license fee revenue related to the SurVeil DCB, expected product gross margins for the remainder of fiscal 2023 and factors that we expect to impact product gross margins, expected operating expenses, expected interest expense, and expected tax (expense) benefit; expected cash use for the fourth quarter of fiscal 2023; our expected cash balance at the end of fiscal 2023; our fiscal 2023 strategic objectives; and further and future growth and value creation in the years to come, 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) 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; (3) possible adverse market conditions and possible adverse impacts on our cash flows; (4) our ability to successfully and profitably commercialize our vascular intervention products; (5) supply chain constraints; (6) whether our operating expenses are effective in generating profitable revenues; (7) disruptions to our business from our plan to reduce our use of cash announced in the second quarter of fiscal 2023, the failure of such plan to achieve its objectives, or cost and expenses associated with such plan; 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, 2022 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 income (loss), non-GAAP operating income (loss) percentage, non-GAAP income (loss) before income taxes, non-GAAP net income (loss), and non-GAAP income (loss) per diluted share. 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 loss per diluted share for fiscal 2023. 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. Surmodics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (in thousands, except per share data) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Revenue: Product sales $ 15,667 $ 13,919 $ 45,251 $ 40,227 Royalties and license fees 34,153 8,795 52,347 26,738 Research, development and other 2,663 2,140 7,016 6,998 Total revenue 52,483 24,854 104,614 73,963 Operating costs and expenses: Product costs 6,921 5,141 17,926 14,745 Research and development 11,232 12,975 36,899 38,350 Selling, general and administrative 12,874 12,854 39,077 33,159 Acquired intangible asset amortization 879 1,024 2,659 3,184 Restructuring expense — — 1,282 — Contingent consideration (gain) expense (835 ) 3 (829 ) 9 Total operating costs and expenses 31,071 31,997 97,014 89,447 Operating income (loss) 21,412 (7,143 ) 7,600 (15,484 ) Other expense, net (763 ) (38 ) (2,324 ) (217 ) Income (loss) before income taxes 20,649 (7,181 ) 5,276 (15,701 ) Income tax (expense) benefit (13,303 ) 1,530 (13,506 ) 3,155 Net income (loss) $ 7,346 $ (5,651 ) $ (8,230 ) $ (12,546 ) Basic net income (loss) per share $ 0.52 $ (0.41 ) $ (0.59 ) $ (0.90 ) Diluted net income (loss) per share $ 0.52 $ (0.41 ) $ (0.59 ) $ (0.90 ) Weighted average number of shares outstanding: Basic 14,050 13,929 14,020 13,907 Diluted 14,072 13,929 14,020 13,907 Surmodics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in thousands) June 30, September 30, 2023 2022 Assets (Unaudited) (See Note) Current Assets: Cash and cash equivalents $ 44,579 $ 18,998 Accounts receivable, net 11,752 10,452 Contract assets — royalties and license fees 7,678 7,116 Inventories, net 14,610 11,819 Prepaids and other 7,231 9,202 Total Current Assets 85,850 57,587 Property and equipment, net 26,571 27,148 Intangible assets, net 27,798 28,145 Goodwill 43,844 40,710 Other assets 4,838 4,769 Total Assets $ 188,901 $ 158,359 Liabilities and Stockholders’ Equity Current Liabilities: Short-term borrowings $ — $ 10,000 Deferred revenue 4,328 4,160 Income tax payable 11,953 — Other current liabilities 15,767 17,919 Total Current Liabilities 32,048 32,079 Long-term debt, net 29,353 — Deferred revenue 3,492 5,088 Other long-term liabilities 11,596 12,800 Total Liabilities 76,489 49,967 Total Stockholders’ Equity 112,412 108,392 Total Liabilities and Stockholders’ Equity $ 188,901 $ 158,359 Note: Derived from audited financial statements as of the date indicated. Surmodics, Inc. and Subsidiaries Condensed Consolidated Statements of Cash Flows (in thousands) (Unaudited) Nine Months Ended June 30, 2023 2022 Operating Activities: Net loss $ (8,230 ) $ (12,546 ) Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Depreciation and amortization 6,365 6,902 Stock-based compensation 5,662 5,198 Deferred taxes (187 ) (2,996 ) Other 217 636 Change in operating assets and liabilities: Accounts receivable and contract assets (1,825 ) (847 ) Inventories (2,790 ) (4,167 ) Prepaids and other (961 ) (1,998 ) Accounts payable (669 ) 349 Accrued liabilities (2,474 ) (1,039 ) Income taxes 15,583 (676 ) Deferred revenue (1,427 ) (3,539 ) Net cash provided by (used in) operating activities 9,264 (14,723 ) Investing Activities: Purchases of property and equipment (2,170 ) (2,798 ) Maturities of available-for-sale securities — 7,600 Net cash (used in) provided by investing activities (2,170 ) 4,802 Financing Activities: Payments of short-term borrowings (10,000 ) — Proceeds from issuance of long-term debt 29,664 — Payments of debt issuance costs (614 ) — Issuance of common stock 803 763 Payments for taxes related to net share settlement of equity awards (888 ) (936 ) Payments for acquisition of in-process research and development (978 ) (500 ) Net cash provided by (used in) financing activities 17,987 (673 ) Effect of exchange rate changes on cash 500 (485 ) Net change in cash and cash equivalents 25,581 (11,079 ) Cash and Cash Equivalents: Beginning of period 18,998 31,153 End of period $ 44,579 $ 20,074 Surmodics, Inc. and Subsidiaries Supplemental Segment Information (in thousands) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Medical Device Revenue Product sales $ 9,299 $ 6,741 $ 25,593 $ 19,970 Royalties 8,220 7,771 23,702 23,015 License fees 25,933 1,024 28,645 3,723 Research, development and other 2,562 1,992 6,799 6,181 Medical Device revenue 46,014 17,528 84,739 52,889 In Vitro Diagnostics Revenue Product sales 6,368 7,178 19,658 20,257 Research, development and other 101 148 217 817 In Vitro Diagnostics revenue 6,469 7,326 19,875 21,074 Total Revenue $ 52,483 $ 24,854 $ 104,614 $ 73,963 Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Operating income (loss): Medical Device $ 21,777 $ (7,308 ) $ 7,483 $ (16,712 ) In Vitro Diagnostics 2,866 3,387 9,450 10,262 Total segment operating income (loss) 24,643 (3,921 ) 16,933 (6,450 ) Corporate (3,231 ) (3,222 ) (9,333 ) (9,034 ) Total operating income (loss) $ 21,412 $ (7,143 ) $ 7,600 $ (15,484 ) Surmodics, Inc. and Subsidiaries Reconciliation of GAAP Measures to Non-GAAP Amounts Schedule of EBITDA and Adjusted EBITDA (in thousands) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Net income (loss) $ 7,346 $ (5,651 ) $ (8,230 ) $ (12,546 ) Income tax expense (benefit) 13,303 (1,530 ) 13,506 (3,155 ) Depreciation and amortization 2,151 2,206 6,365 6,902 Interest expense, net 884 145 2,594 410 Investment income, net (182 ) (22 ) (531 ) (73 ) EBITDA 23,502 (4,852 ) 13,704 (8,462 ) Adjustments: Stock-based compensation expense 1,915 1,799 5,662 5,198 Restructuring expense (1) — — 1,282 — Contingent consideration fair value adjustment (2) (829 ) — (829 ) — Adjusted EBITDA $ 24,588 $ (3,053 ) $ 19,819 $ (3,264 ) Surmodics, Inc. and Subsidiaries Guidance Reconciliation: Estimated Non-GAAP Diluted EPS For the Fiscal Year Ending September 30, 2023 (Unaudited) Fiscal 2023 Full-Year Estimate Low High GAAP Diluted EPS $ (0.55 ) $ (0.40 ) Per diluted share: Amortization of acquired intangible assets (3) 0.23 0.23 Restructuring expense (1) 0.09 0.09 Contingent consideration fair value adjustment (2) (0.06 ) (0.06 ) Non-GAAP Diluted EPS $ (0.29 ) $ (0.14 ) Diluted weighted average shares outstanding 14,030 Surmodics, Inc. and Subsidiaries Net Income (Loss) and Diluted EPS GAAP to Non-GAAP Reconciliation (in thousands, except per share data) (Unaudited) Three Months Ended June 30, 2023 Revenue Operating Income Income Before Income Taxes Net Income (4) Diluted EPS GAAP $ 52,483 $ 21,412 40.8 % $ 20,649 $ 7,346 $ 0.52 Adjustments: Amortization of acquired intangible assets (3) — 879 1.7 % 879 813 0.06 Contingent consideration fair value adjustment (2) — (829 ) (1.6 )% (829 ) (829 ) (0.06 ) Non-GAAP $ 52,483 $ 21,462 40.9 % $ 20,699 $ 7,330 $ 0.52 Diluted weighted average shares outstanding (5) 14,072 Three Months Ended June 30, 2022 Revenue Operating Loss Loss Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 24,854 $ (7,143 ) (28.7 )% $ (7,181 ) $ (5,651 ) $ (0.41 ) Adjustments: Amortization of acquired intangible assets (3) — 1,024 4.1 % 1,024 930 0.07 Non-GAAP $ 24,854 $ (6,119 ) (24.6 )% $ (6,157 ) $ (4,721 ) $ (0.34 ) Diluted weighted average shares outstanding (5) 13,929 Nine Months Ended June 30, 2023 Revenue Operating Income Income Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 104,614 $ 7,600 7.3 % $ 5,276 $ (8,230 ) $ (0.59 ) Adjustments: Amortization of acquired intangible assets (3) — 2,659 2.5 % 2,659 2,467 0.18 Restructuring expense (1) — 1,282 1.2 % 1,282 1,282 0.09 Contingent consideration fair value adjustment (2) — (829 ) (0.8 )% (829 ) (829 ) (0.06 ) Non-GAAP $ 104,614 $ 10,712 10.2 % $ 8,388 $ (5,310 ) $ (0.38 ) Diluted weighted average shares outstanding (5) 14,020 Nine Months Ended June 30, 2022 Revenue Operating Loss Loss Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 73,963 $ (15,484 ) (20.9 )% $ (15,701 ) $ (12,546 ) $ (0.90 ) Adjustments: Amortization of acquired intangible assets (3) — 3,184 4.3 % 3,184 2,893 0.21 Non-GAAP $ 73,963 $ (12,300 ) (16.6 )% $ (12,517 ) $ (9,653 ) $ (0.69 ) Diluted weighted average shares outstanding (5) 13,907 (1) Restructuring expense consists of severance and related costs specifically associated with a workforce restructuring implemented in the second quarter of fiscal 2023. (2) Represents accounting adjustments to state acquisition-related contingent consideration liabilities at their estimated fair value as of the period end date, including adjustments to the liabilities’ fair values related to changes in the timing and/or probability of achieving milestones and accretion expense for the passage of time. (3) Represents amortization of business acquisition-related intangible assets and associated tax impact. A significant portion of the business acquisition-related amortization is not tax deductible. (4) Net income (loss) includes the effect of the above adjustments on income tax (expense) benefit, taking into account deferred taxes net of valuation allowances, as well as non-deductible items. Income tax impacts were estimated using the applicable statutory rate (21% in the U.S. and 12.5% in Ireland). (5) Diluted weighted average shares outstanding used in the calculation of EPS was the same for GAAP EPS and Non-GAAP EPS. 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Surmodics Reports Third Quarter of Fiscal Year 2023 Financial Results; Updates Fiscal Year 2023 Financial Guidance By: Surmodics, Inc. via Business Wire August 02, 2023 at 07:31 AM EDT 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 third quarter ended June 30, 2023, and updated its financial guidance for its fiscal year ending September 30, 2023. Third Quarter Fiscal 2023 Financial Summary Total Revenue of $52.5 million, an increase of 111% year-over-year Recognized $24.6 million in license fee revenue upon receipt of a $27.0 million milestone payment associated with obtaining FDA premarket approval of the SurVeil™ DCB under the company’s Development and Distribution Agreement with Abbott GAAP Diluted EPS of $0.52, compared to $(0.41) in the prior-year period Non-GAAP Diluted EPS of $0.52, compared to $(0.34) in the prior-year period Third Quarter and Recent Business Highlights On April 19, 2023, Surmodics announced the first successful patient use of the Sublime™ radial access microcatheter, the industry’s first suite of torqueable peripheral microcatheters, designed for navigating tortuosity and crossing complex lesions and available for both transradial and transfemoral procedures. On April 20, 2023, Surmodics announced enrollment of the first patient in PROWL, the Pounce™ Thrombectomy System Retrospective Registry, to collect real-world efficacy and safety outcomes data for endovascular interventions using the Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. On June 14, 2023, Surmodics announced the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System, which will allow for efficient clot removal in below-the-knee peripheral arteries (2 mm to 4 mm in diameter), expanding the addressable market for the Pounce platform. On June 20, 2023, Surmodics announced the receipt of FDA premarket approval for its SurVeil™ drug-coated balloon (DCB). The SurVeil DCB may now be marketed and sold in the U.S. by the company’s exclusive distribution partner, Abbott Vascular, Inc. (Abbott). The SurVeil DCB is a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease, includes a proprietary drug-excipient formulation for a durable balloon coating, and is manufactured using an innovative process to improve coating uniformity. “Our third quarter was marked by a combination of strong financial performance – including total revenue growth of 111% year-over-year – and notable progress with respect to our key strategic objectives for fiscal 2023,” said Gary Maharaj, President and CEO of Surmodics, Inc. “Most importantly, we obtained FDA premarket approval for the SurVeil DCB, our next-generation drug-coated balloon, secured a related $27 million milestone payment to strengthen our balance sheet, and made progress in preparing to support its commercial launch. In addition, we expanded the commercial adoption and utilization of our Pounce arterial thrombectomy and Sublime radial access platforms, while advancing our pipeline of additional vascular intervention technologies: secured FDA 510(k) clearance for our Pounce LP Thrombectomy System, initiated the limited market evaluation of our Sublime radial access microcatheter, and continued the limited market evaluation of our Pounce Venous Thrombectomy System.” Mr. Maharaj continued, “Our impressive total revenue performance in the quarter was driven by 163% growth year-over-year in our Medical Device segment, which benefited from the aforementioned milestone payment, along with strong underlying performance – including product sales growth of 38% year-over-year fueled primarily by sales of our Pounce and Sublime products. Lastly, we made notable year-over-year improvements in our profitability profile from an operating income and adjusted EBITDA standpoint, while continuing to control our expenses and manage our cash use. Our increased guidance reflects our impressive financial and operational performance in the third quarter and latest expectations for the balance of the year. Looking ahead, we remain focused on bringing fiscal 2023 to a strong conclusion by continuing to execute against our stated strategic objectives, laying the groundwork for further growth and value creation in the years to come.” Third Quarter Fiscal 2023 Financial Results Three Months Ended June 30, Increase (Decrease) 2023 2022 $ % Revenue: Medical Device $ 46,014 $ 17,528 $ 28,486 163 % In Vitro Diagnostics 6,469 7,326 (857 ) (12 )% Total revenue $ 52,483 $ 24,854 $ 27,629 111 % Total revenue increased $27.6 million, or 111%, to $52.5 million, compared to $24.9 million in the third quarter of fiscal 2022. Medical Device revenue increased $28.5 million, or 163%, to $46.0 million, compared to $17.5 million in the third quarter of fiscal 2022. Medical Device revenue in the third quarter of fiscal 2023 included a total of $25.9 million in license fee revenue from the company’s Development and Distribution Agreement with Abbott for the SurVeil DCB – of which $24.6 million was revenue recognized on the $27.0 million milestone payment received in the period associated with obtaining FDA approval of the SurVeil DCB – compared to $1.0 million of total license fee revenue in the prior-year period. Medical Device revenue growth was broad-based, including significant contributions from Pounce thrombectomy and Sublime radial access device platforms, as well as increased sales of performance coating reagents. In Vitro Diagnostics (“IVD”) revenue decreased $0.9 million, or 12%, to $6.5 million, compared to $7.3 million in the third quarter of fiscal 2022, driven primarily by active management of inventory levels by certain customers. Product gross profit (defined as product sales less product costs) was $8.7 million and was unchanged compared to the third quarter of fiscal 2022. Product gross margin (defined as product gross profit as a percentage of product sales) was 55.8%, compared to 63.1% in the third quarter of fiscal 2022. The decline in product gross margin was primarily driven by the adverse mix impact from increased device product sales, which have lower product gross margins due to low production volumes during the scale-up phase following initial commercialization. Operating costs and expenses, excluding product costs, decreased $2.7 million, or 10%, to $24.2 million, compared to $26.9 million in the third quarter of fiscal 2022. The decrease was driven primarily by lower research and development expenses as the result of the spending reduction plan implemented in the second quarter of fiscal 2023. In addition, operating costs and expenses in the third quarter of fiscal 2023 included a $0.8 million gain from the fair value adjustment of acquisition-related contingent consideration. GAAP net income was $7.3 million, or $0.52 per diluted share, compared to GAAP net loss of $(5.7) million, or $(0.41) per diluted share in the third quarter of fiscal 2022. Non-GAAP net income was $7.3 million, or $0.52 per diluted share, compared to Non-GAAP net loss of $(4.7) million, or $(0.34) per diluted share in the third quarter of fiscal 2022. Adjusted EBITDA was $24.6 million, compared to Adjusted EBITDA loss of $(3.1) million in the third quarter of fiscal 2022. Balance Sheet Summary As of June 30, 2023, Surmodics reported $44.6 million in cash and cash equivalents, $5.0 million in outstanding borrowings on its $25.0 million revolving credit facility, and $25.0 million in outstanding borrowings on its term loan facility. Additional draws on the term loan facility may be made in $10.0 million minimum increments, up to a total of $75.0 million through December 31, 2024. A third tranche of up to $25.0 million on the term loan facility may be available through December 31, 2024 at the lender’s option. Surmodics reported $25.9 million of cash provided by operating activities and $0.5 million in capital expenditures in the third quarter of fiscal 2023. Fiscal Year 2023 Financial Guidance Surmodics now expects fiscal year 2023 total revenue to range from $130 million to $132 million, representing an increase of 30% to 32% compared to the prior year. The company’s prior guidance called for fiscal year 2023 total revenue of $103 million to $106 million, representing an increase of 3% to 6% compared to the prior year. The company now expects fiscal 2023 GAAP diluted loss per share to range from $(0.55) to $(0.40). The company’s prior guidance called for fiscal 2023 GAAP diluted loss per share of $(2.30) to $(2.00). Non-GAAP diluted loss per share in fiscal 2023 is expected to range from $(0.29) to $(0.14). The company’s prior guidance called for fiscal 2023 Non-GAAP diluted loss per share of $(1.98) to $(1.68). Conference Call Today at 7:00 a.m. CT (8:00 a.m. ET) Surmodics is hosting a live webcast at 7:00 a.m. CT (8:00 a.m. ET) today to discuss third quarter of fiscal 2023 financial results and accomplishments, and to host a question-and-answer session. To access the webcast, please go to “Events & Presentations” under the “Investors” section of the company’s website at https://surmodics.gcs-web.com/events-and-presentations, and click on the webcast icon under “Upcoming Events.” To listen to the live teleconference, dial 877-407-8293 (international callers may dial 201-689-8349) and provide access ID: 13739898. An audio replay of the conference call will be available beginning at 11:00 a.m. CT today, until 11:00 a.m. CT on Wednesday, August 16, and can be accessed by dialing 877-660-6853 (international callers may dial 201-612-7415) and entering access ID: 13739898. In addition, the webcast and transcript will be archived on the company’s website following the call. About Surmodics, Inc. Surmodics, Inc. is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also 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. 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: expectations of the timing of an initial stocking order for SurVeil DCB products and of Abbott’s commercialization of the product; being well positioned to support Abbott’s commercial launch of the SurVeil DCB; our belief that the SurVeil DCB will complement and enhance Abbott’s existing product portfolio; our expectation about working with the FDA to update the SurVeil DCB product labeling to reflect currently available paclitaxel data; our future prospects; the expected customer base for our Sublime radial and Pounce arterial thrombectomy platforms by year end and their expected year-over-year growth rate for full fiscal 2023; our expectations regarding expanding the addressable market for our Pounce arterial thrombectomy system with the addition of new products and clinical indications; expectations regarding the conduct and timing of limited market introductions of certain products and of commercialization of products; our expectations related to the PROWL U.S. registry study and expectation of sharing interim data therefrom; our fiscal 2023 financial guidance and related assumptions, including assumptions in our revenue guidance provided for modeling purposes, expected revenue growth rates, expected license fee revenue related to the SurVeil DCB, expected product gross margins for the remainder of fiscal 2023 and factors that we expect to impact product gross margins, expected operating expenses, expected interest expense, and expected tax (expense) benefit; expected cash use for the fourth quarter of fiscal 2023; our expected cash balance at the end of fiscal 2023; our fiscal 2023 strategic objectives; and further and future growth and value creation in the years to come, 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) 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; (3) possible adverse market conditions and possible adverse impacts on our cash flows; (4) our ability to successfully and profitably commercialize our vascular intervention products; (5) supply chain constraints; (6) whether our operating expenses are effective in generating profitable revenues; (7) disruptions to our business from our plan to reduce our use of cash announced in the second quarter of fiscal 2023, the failure of such plan to achieve its objectives, or cost and expenses associated with such plan; 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, 2022 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 income (loss), non-GAAP operating income (loss) percentage, non-GAAP income (loss) before income taxes, non-GAAP net income (loss), and non-GAAP income (loss) per diluted share. 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 loss per diluted share for fiscal 2023. 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. Surmodics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (in thousands, except per share data) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Revenue: Product sales $ 15,667 $ 13,919 $ 45,251 $ 40,227 Royalties and license fees 34,153 8,795 52,347 26,738 Research, development and other 2,663 2,140 7,016 6,998 Total revenue 52,483 24,854 104,614 73,963 Operating costs and expenses: Product costs 6,921 5,141 17,926 14,745 Research and development 11,232 12,975 36,899 38,350 Selling, general and administrative 12,874 12,854 39,077 33,159 Acquired intangible asset amortization 879 1,024 2,659 3,184 Restructuring expense — — 1,282 — Contingent consideration (gain) expense (835 ) 3 (829 ) 9 Total operating costs and expenses 31,071 31,997 97,014 89,447 Operating income (loss) 21,412 (7,143 ) 7,600 (15,484 ) Other expense, net (763 ) (38 ) (2,324 ) (217 ) Income (loss) before income taxes 20,649 (7,181 ) 5,276 (15,701 ) Income tax (expense) benefit (13,303 ) 1,530 (13,506 ) 3,155 Net income (loss) $ 7,346 $ (5,651 ) $ (8,230 ) $ (12,546 ) Basic net income (loss) per share $ 0.52 $ (0.41 ) $ (0.59 ) $ (0.90 ) Diluted net income (loss) per share $ 0.52 $ (0.41 ) $ (0.59 ) $ (0.90 ) Weighted average number of shares outstanding: Basic 14,050 13,929 14,020 13,907 Diluted 14,072 13,929 14,020 13,907 Surmodics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in thousands) June 30, September 30, 2023 2022 Assets (Unaudited) (See Note) Current Assets: Cash and cash equivalents $ 44,579 $ 18,998 Accounts receivable, net 11,752 10,452 Contract assets — royalties and license fees 7,678 7,116 Inventories, net 14,610 11,819 Prepaids and other 7,231 9,202 Total Current Assets 85,850 57,587 Property and equipment, net 26,571 27,148 Intangible assets, net 27,798 28,145 Goodwill 43,844 40,710 Other assets 4,838 4,769 Total Assets $ 188,901 $ 158,359 Liabilities and Stockholders’ Equity Current Liabilities: Short-term borrowings $ — $ 10,000 Deferred revenue 4,328 4,160 Income tax payable 11,953 — Other current liabilities 15,767 17,919 Total Current Liabilities 32,048 32,079 Long-term debt, net 29,353 — Deferred revenue 3,492 5,088 Other long-term liabilities 11,596 12,800 Total Liabilities 76,489 49,967 Total Stockholders’ Equity 112,412 108,392 Total Liabilities and Stockholders’ Equity $ 188,901 $ 158,359 Note: Derived from audited financial statements as of the date indicated. Surmodics, Inc. and Subsidiaries Condensed Consolidated Statements of Cash Flows (in thousands) (Unaudited) Nine Months Ended June 30, 2023 2022 Operating Activities: Net loss $ (8,230 ) $ (12,546 ) Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Depreciation and amortization 6,365 6,902 Stock-based compensation 5,662 5,198 Deferred taxes (187 ) (2,996 ) Other 217 636 Change in operating assets and liabilities: Accounts receivable and contract assets (1,825 ) (847 ) Inventories (2,790 ) (4,167 ) Prepaids and other (961 ) (1,998 ) Accounts payable (669 ) 349 Accrued liabilities (2,474 ) (1,039 ) Income taxes 15,583 (676 ) Deferred revenue (1,427 ) (3,539 ) Net cash provided by (used in) operating activities 9,264 (14,723 ) Investing Activities: Purchases of property and equipment (2,170 ) (2,798 ) Maturities of available-for-sale securities — 7,600 Net cash (used in) provided by investing activities (2,170 ) 4,802 Financing Activities: Payments of short-term borrowings (10,000 ) — Proceeds from issuance of long-term debt 29,664 — Payments of debt issuance costs (614 ) — Issuance of common stock 803 763 Payments for taxes related to net share settlement of equity awards (888 ) (936 ) Payments for acquisition of in-process research and development (978 ) (500 ) Net cash provided by (used in) financing activities 17,987 (673 ) Effect of exchange rate changes on cash 500 (485 ) Net change in cash and cash equivalents 25,581 (11,079 ) Cash and Cash Equivalents: Beginning of period 18,998 31,153 End of period $ 44,579 $ 20,074 Surmodics, Inc. and Subsidiaries Supplemental Segment Information (in thousands) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Medical Device Revenue Product sales $ 9,299 $ 6,741 $ 25,593 $ 19,970 Royalties 8,220 7,771 23,702 23,015 License fees 25,933 1,024 28,645 3,723 Research, development and other 2,562 1,992 6,799 6,181 Medical Device revenue 46,014 17,528 84,739 52,889 In Vitro Diagnostics Revenue Product sales 6,368 7,178 19,658 20,257 Research, development and other 101 148 217 817 In Vitro Diagnostics revenue 6,469 7,326 19,875 21,074 Total Revenue $ 52,483 $ 24,854 $ 104,614 $ 73,963 Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Operating income (loss): Medical Device $ 21,777 $ (7,308 ) $ 7,483 $ (16,712 ) In Vitro Diagnostics 2,866 3,387 9,450 10,262 Total segment operating income (loss) 24,643 (3,921 ) 16,933 (6,450 ) Corporate (3,231 ) (3,222 ) (9,333 ) (9,034 ) Total operating income (loss) $ 21,412 $ (7,143 ) $ 7,600 $ (15,484 ) Surmodics, Inc. and Subsidiaries Reconciliation of GAAP Measures to Non-GAAP Amounts Schedule of EBITDA and Adjusted EBITDA (in thousands) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Net income (loss) $ 7,346 $ (5,651 ) $ (8,230 ) $ (12,546 ) Income tax expense (benefit) 13,303 (1,530 ) 13,506 (3,155 ) Depreciation and amortization 2,151 2,206 6,365 6,902 Interest expense, net 884 145 2,594 410 Investment income, net (182 ) (22 ) (531 ) (73 ) EBITDA 23,502 (4,852 ) 13,704 (8,462 ) Adjustments: Stock-based compensation expense 1,915 1,799 5,662 5,198 Restructuring expense (1) — — 1,282 — Contingent consideration fair value adjustment (2) (829 ) — (829 ) — Adjusted EBITDA $ 24,588 $ (3,053 ) $ 19,819 $ (3,264 ) Surmodics, Inc. and Subsidiaries Guidance Reconciliation: Estimated Non-GAAP Diluted EPS For the Fiscal Year Ending September 30, 2023 (Unaudited) Fiscal 2023 Full-Year Estimate Low High GAAP Diluted EPS $ (0.55 ) $ (0.40 ) Per diluted share: Amortization of acquired intangible assets (3) 0.23 0.23 Restructuring expense (1) 0.09 0.09 Contingent consideration fair value adjustment (2) (0.06 ) (0.06 ) Non-GAAP Diluted EPS $ (0.29 ) $ (0.14 ) Diluted weighted average shares outstanding 14,030 Surmodics, Inc. and Subsidiaries Net Income (Loss) and Diluted EPS GAAP to Non-GAAP Reconciliation (in thousands, except per share data) (Unaudited) Three Months Ended June 30, 2023 Revenue Operating Income Income Before Income Taxes Net Income (4) Diluted EPS GAAP $ 52,483 $ 21,412 40.8 % $ 20,649 $ 7,346 $ 0.52 Adjustments: Amortization of acquired intangible assets (3) — 879 1.7 % 879 813 0.06 Contingent consideration fair value adjustment (2) — (829 ) (1.6 )% (829 ) (829 ) (0.06 ) Non-GAAP $ 52,483 $ 21,462 40.9 % $ 20,699 $ 7,330 $ 0.52 Diluted weighted average shares outstanding (5) 14,072 Three Months Ended June 30, 2022 Revenue Operating Loss Loss Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 24,854 $ (7,143 ) (28.7 )% $ (7,181 ) $ (5,651 ) $ (0.41 ) Adjustments: Amortization of acquired intangible assets (3) — 1,024 4.1 % 1,024 930 0.07 Non-GAAP $ 24,854 $ (6,119 ) (24.6 )% $ (6,157 ) $ (4,721 ) $ (0.34 ) Diluted weighted average shares outstanding (5) 13,929 Nine Months Ended June 30, 2023 Revenue Operating Income Income Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 104,614 $ 7,600 7.3 % $ 5,276 $ (8,230 ) $ (0.59 ) Adjustments: Amortization of acquired intangible assets (3) — 2,659 2.5 % 2,659 2,467 0.18 Restructuring expense (1) — 1,282 1.2 % 1,282 1,282 0.09 Contingent consideration fair value adjustment (2) — (829 ) (0.8 )% (829 ) (829 ) (0.06 ) Non-GAAP $ 104,614 $ 10,712 10.2 % $ 8,388 $ (5,310 ) $ (0.38 ) Diluted weighted average shares outstanding (5) 14,020 Nine Months Ended June 30, 2022 Revenue Operating Loss Loss Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 73,963 $ (15,484 ) (20.9 )% $ (15,701 ) $ (12,546 ) $ (0.90 ) Adjustments: Amortization of acquired intangible assets (3) — 3,184 4.3 % 3,184 2,893 0.21 Non-GAAP $ 73,963 $ (12,300 ) (16.6 )% $ (12,517 ) $ (9,653 ) $ (0.69 ) Diluted weighted average shares outstanding (5) 13,907 (1) Restructuring expense consists of severance and related costs specifically associated with a workforce restructuring implemented in the second quarter of fiscal 2023. (2) Represents accounting adjustments to state acquisition-related contingent consideration liabilities at their estimated fair value as of the period end date, including adjustments to the liabilities’ fair values related to changes in the timing and/or probability of achieving milestones and accretion expense for the passage of time. (3) Represents amortization of business acquisition-related intangible assets and associated tax impact. A significant portion of the business acquisition-related amortization is not tax deductible. (4) Net income (loss) includes the effect of the above adjustments on income tax (expense) benefit, taking into account deferred taxes net of valuation allowances, as well as non-deductible items. Income tax impacts were estimated using the applicable statutory rate (21% in the U.S. and 12.5% in Ireland). (5) Diluted weighted average shares outstanding used in the calculation of EPS was the same for GAAP EPS and Non-GAAP EPS. View source version on businesswire.com: https://www.businesswire.com/news/home/20230802023507/en/Contacts Surmodics Investor Inquiries Jack Powell, Investor Relations ir@surmodics.com
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 third quarter ended June 30, 2023, and updated its financial guidance for its fiscal year ending September 30, 2023. Third Quarter Fiscal 2023 Financial Summary Total Revenue of $52.5 million, an increase of 111% year-over-year Recognized $24.6 million in license fee revenue upon receipt of a $27.0 million milestone payment associated with obtaining FDA premarket approval of the SurVeil™ DCB under the company’s Development and Distribution Agreement with Abbott GAAP Diluted EPS of $0.52, compared to $(0.41) in the prior-year period Non-GAAP Diluted EPS of $0.52, compared to $(0.34) in the prior-year period Third Quarter and Recent Business Highlights On April 19, 2023, Surmodics announced the first successful patient use of the Sublime™ radial access microcatheter, the industry’s first suite of torqueable peripheral microcatheters, designed for navigating tortuosity and crossing complex lesions and available for both transradial and transfemoral procedures. On April 20, 2023, Surmodics announced enrollment of the first patient in PROWL, the Pounce™ Thrombectomy System Retrospective Registry, to collect real-world efficacy and safety outcomes data for endovascular interventions using the Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. On June 14, 2023, Surmodics announced the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System, which will allow for efficient clot removal in below-the-knee peripheral arteries (2 mm to 4 mm in diameter), expanding the addressable market for the Pounce platform. On June 20, 2023, Surmodics announced the receipt of FDA premarket approval for its SurVeil™ drug-coated balloon (DCB). The SurVeil DCB may now be marketed and sold in the U.S. by the company’s exclusive distribution partner, Abbott Vascular, Inc. (Abbott). The SurVeil DCB is a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease, includes a proprietary drug-excipient formulation for a durable balloon coating, and is manufactured using an innovative process to improve coating uniformity. “Our third quarter was marked by a combination of strong financial performance – including total revenue growth of 111% year-over-year – and notable progress with respect to our key strategic objectives for fiscal 2023,” said Gary Maharaj, President and CEO of Surmodics, Inc. “Most importantly, we obtained FDA premarket approval for the SurVeil DCB, our next-generation drug-coated balloon, secured a related $27 million milestone payment to strengthen our balance sheet, and made progress in preparing to support its commercial launch. In addition, we expanded the commercial adoption and utilization of our Pounce arterial thrombectomy and Sublime radial access platforms, while advancing our pipeline of additional vascular intervention technologies: secured FDA 510(k) clearance for our Pounce LP Thrombectomy System, initiated the limited market evaluation of our Sublime radial access microcatheter, and continued the limited market evaluation of our Pounce Venous Thrombectomy System.” Mr. Maharaj continued, “Our impressive total revenue performance in the quarter was driven by 163% growth year-over-year in our Medical Device segment, which benefited from the aforementioned milestone payment, along with strong underlying performance – including product sales growth of 38% year-over-year fueled primarily by sales of our Pounce and Sublime products. Lastly, we made notable year-over-year improvements in our profitability profile from an operating income and adjusted EBITDA standpoint, while continuing to control our expenses and manage our cash use. Our increased guidance reflects our impressive financial and operational performance in the third quarter and latest expectations for the balance of the year. Looking ahead, we remain focused on bringing fiscal 2023 to a strong conclusion by continuing to execute against our stated strategic objectives, laying the groundwork for further growth and value creation in the years to come.” Third Quarter Fiscal 2023 Financial Results Three Months Ended June 30, Increase (Decrease) 2023 2022 $ % Revenue: Medical Device $ 46,014 $ 17,528 $ 28,486 163 % In Vitro Diagnostics 6,469 7,326 (857 ) (12 )% Total revenue $ 52,483 $ 24,854 $ 27,629 111 % Total revenue increased $27.6 million, or 111%, to $52.5 million, compared to $24.9 million in the third quarter of fiscal 2022. Medical Device revenue increased $28.5 million, or 163%, to $46.0 million, compared to $17.5 million in the third quarter of fiscal 2022. Medical Device revenue in the third quarter of fiscal 2023 included a total of $25.9 million in license fee revenue from the company’s Development and Distribution Agreement with Abbott for the SurVeil DCB – of which $24.6 million was revenue recognized on the $27.0 million milestone payment received in the period associated with obtaining FDA approval of the SurVeil DCB – compared to $1.0 million of total license fee revenue in the prior-year period. Medical Device revenue growth was broad-based, including significant contributions from Pounce thrombectomy and Sublime radial access device platforms, as well as increased sales of performance coating reagents. In Vitro Diagnostics (“IVD”) revenue decreased $0.9 million, or 12%, to $6.5 million, compared to $7.3 million in the third quarter of fiscal 2022, driven primarily by active management of inventory levels by certain customers. Product gross profit (defined as product sales less product costs) was $8.7 million and was unchanged compared to the third quarter of fiscal 2022. Product gross margin (defined as product gross profit as a percentage of product sales) was 55.8%, compared to 63.1% in the third quarter of fiscal 2022. The decline in product gross margin was primarily driven by the adverse mix impact from increased device product sales, which have lower product gross margins due to low production volumes during the scale-up phase following initial commercialization. Operating costs and expenses, excluding product costs, decreased $2.7 million, or 10%, to $24.2 million, compared to $26.9 million in the third quarter of fiscal 2022. The decrease was driven primarily by lower research and development expenses as the result of the spending reduction plan implemented in the second quarter of fiscal 2023. In addition, operating costs and expenses in the third quarter of fiscal 2023 included a $0.8 million gain from the fair value adjustment of acquisition-related contingent consideration. GAAP net income was $7.3 million, or $0.52 per diluted share, compared to GAAP net loss of $(5.7) million, or $(0.41) per diluted share in the third quarter of fiscal 2022. Non-GAAP net income was $7.3 million, or $0.52 per diluted share, compared to Non-GAAP net loss of $(4.7) million, or $(0.34) per diluted share in the third quarter of fiscal 2022. Adjusted EBITDA was $24.6 million, compared to Adjusted EBITDA loss of $(3.1) million in the third quarter of fiscal 2022. Balance Sheet Summary As of June 30, 2023, Surmodics reported $44.6 million in cash and cash equivalents, $5.0 million in outstanding borrowings on its $25.0 million revolving credit facility, and $25.0 million in outstanding borrowings on its term loan facility. Additional draws on the term loan facility may be made in $10.0 million minimum increments, up to a total of $75.0 million through December 31, 2024. A third tranche of up to $25.0 million on the term loan facility may be available through December 31, 2024 at the lender’s option. Surmodics reported $25.9 million of cash provided by operating activities and $0.5 million in capital expenditures in the third quarter of fiscal 2023. Fiscal Year 2023 Financial Guidance Surmodics now expects fiscal year 2023 total revenue to range from $130 million to $132 million, representing an increase of 30% to 32% compared to the prior year. The company’s prior guidance called for fiscal year 2023 total revenue of $103 million to $106 million, representing an increase of 3% to 6% compared to the prior year. The company now expects fiscal 2023 GAAP diluted loss per share to range from $(0.55) to $(0.40). The company’s prior guidance called for fiscal 2023 GAAP diluted loss per share of $(2.30) to $(2.00). Non-GAAP diluted loss per share in fiscal 2023 is expected to range from $(0.29) to $(0.14). The company’s prior guidance called for fiscal 2023 Non-GAAP diluted loss per share of $(1.98) to $(1.68). Conference Call Today at 7:00 a.m. CT (8:00 a.m. ET) Surmodics is hosting a live webcast at 7:00 a.m. CT (8:00 a.m. ET) today to discuss third quarter of fiscal 2023 financial results and accomplishments, and to host a question-and-answer session. To access the webcast, please go to “Events & Presentations” under the “Investors” section of the company’s website at https://surmodics.gcs-web.com/events-and-presentations, and click on the webcast icon under “Upcoming Events.” To listen to the live teleconference, dial 877-407-8293 (international callers may dial 201-689-8349) and provide access ID: 13739898. An audio replay of the conference call will be available beginning at 11:00 a.m. CT today, until 11:00 a.m. CT on Wednesday, August 16, and can be accessed by dialing 877-660-6853 (international callers may dial 201-612-7415) and entering access ID: 13739898. In addition, the webcast and transcript will be archived on the company’s website following the call. About Surmodics, Inc. Surmodics, Inc. is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also 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. 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: expectations of the timing of an initial stocking order for SurVeil DCB products and of Abbott’s commercialization of the product; being well positioned to support Abbott’s commercial launch of the SurVeil DCB; our belief that the SurVeil DCB will complement and enhance Abbott’s existing product portfolio; our expectation about working with the FDA to update the SurVeil DCB product labeling to reflect currently available paclitaxel data; our future prospects; the expected customer base for our Sublime radial and Pounce arterial thrombectomy platforms by year end and their expected year-over-year growth rate for full fiscal 2023; our expectations regarding expanding the addressable market for our Pounce arterial thrombectomy system with the addition of new products and clinical indications; expectations regarding the conduct and timing of limited market introductions of certain products and of commercialization of products; our expectations related to the PROWL U.S. registry study and expectation of sharing interim data therefrom; our fiscal 2023 financial guidance and related assumptions, including assumptions in our revenue guidance provided for modeling purposes, expected revenue growth rates, expected license fee revenue related to the SurVeil DCB, expected product gross margins for the remainder of fiscal 2023 and factors that we expect to impact product gross margins, expected operating expenses, expected interest expense, and expected tax (expense) benefit; expected cash use for the fourth quarter of fiscal 2023; our expected cash balance at the end of fiscal 2023; our fiscal 2023 strategic objectives; and further and future growth and value creation in the years to come, 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) 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; (3) possible adverse market conditions and possible adverse impacts on our cash flows; (4) our ability to successfully and profitably commercialize our vascular intervention products; (5) supply chain constraints; (6) whether our operating expenses are effective in generating profitable revenues; (7) disruptions to our business from our plan to reduce our use of cash announced in the second quarter of fiscal 2023, the failure of such plan to achieve its objectives, or cost and expenses associated with such plan; 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, 2022 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 income (loss), non-GAAP operating income (loss) percentage, non-GAAP income (loss) before income taxes, non-GAAP net income (loss), and non-GAAP income (loss) per diluted share. 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 loss per diluted share for fiscal 2023. 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. Surmodics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (in thousands, except per share data) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Revenue: Product sales $ 15,667 $ 13,919 $ 45,251 $ 40,227 Royalties and license fees 34,153 8,795 52,347 26,738 Research, development and other 2,663 2,140 7,016 6,998 Total revenue 52,483 24,854 104,614 73,963 Operating costs and expenses: Product costs 6,921 5,141 17,926 14,745 Research and development 11,232 12,975 36,899 38,350 Selling, general and administrative 12,874 12,854 39,077 33,159 Acquired intangible asset amortization 879 1,024 2,659 3,184 Restructuring expense — — 1,282 — Contingent consideration (gain) expense (835 ) 3 (829 ) 9 Total operating costs and expenses 31,071 31,997 97,014 89,447 Operating income (loss) 21,412 (7,143 ) 7,600 (15,484 ) Other expense, net (763 ) (38 ) (2,324 ) (217 ) Income (loss) before income taxes 20,649 (7,181 ) 5,276 (15,701 ) Income tax (expense) benefit (13,303 ) 1,530 (13,506 ) 3,155 Net income (loss) $ 7,346 $ (5,651 ) $ (8,230 ) $ (12,546 ) Basic net income (loss) per share $ 0.52 $ (0.41 ) $ (0.59 ) $ (0.90 ) Diluted net income (loss) per share $ 0.52 $ (0.41 ) $ (0.59 ) $ (0.90 ) Weighted average number of shares outstanding: Basic 14,050 13,929 14,020 13,907 Diluted 14,072 13,929 14,020 13,907 Surmodics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in thousands) June 30, September 30, 2023 2022 Assets (Unaudited) (See Note) Current Assets: Cash and cash equivalents $ 44,579 $ 18,998 Accounts receivable, net 11,752 10,452 Contract assets — royalties and license fees 7,678 7,116 Inventories, net 14,610 11,819 Prepaids and other 7,231 9,202 Total Current Assets 85,850 57,587 Property and equipment, net 26,571 27,148 Intangible assets, net 27,798 28,145 Goodwill 43,844 40,710 Other assets 4,838 4,769 Total Assets $ 188,901 $ 158,359 Liabilities and Stockholders’ Equity Current Liabilities: Short-term borrowings $ — $ 10,000 Deferred revenue 4,328 4,160 Income tax payable 11,953 — Other current liabilities 15,767 17,919 Total Current Liabilities 32,048 32,079 Long-term debt, net 29,353 — Deferred revenue 3,492 5,088 Other long-term liabilities 11,596 12,800 Total Liabilities 76,489 49,967 Total Stockholders’ Equity 112,412 108,392 Total Liabilities and Stockholders’ Equity $ 188,901 $ 158,359 Note: Derived from audited financial statements as of the date indicated. Surmodics, Inc. and Subsidiaries Condensed Consolidated Statements of Cash Flows (in thousands) (Unaudited) Nine Months Ended June 30, 2023 2022 Operating Activities: Net loss $ (8,230 ) $ (12,546 ) Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Depreciation and amortization 6,365 6,902 Stock-based compensation 5,662 5,198 Deferred taxes (187 ) (2,996 ) Other 217 636 Change in operating assets and liabilities: Accounts receivable and contract assets (1,825 ) (847 ) Inventories (2,790 ) (4,167 ) Prepaids and other (961 ) (1,998 ) Accounts payable (669 ) 349 Accrued liabilities (2,474 ) (1,039 ) Income taxes 15,583 (676 ) Deferred revenue (1,427 ) (3,539 ) Net cash provided by (used in) operating activities 9,264 (14,723 ) Investing Activities: Purchases of property and equipment (2,170 ) (2,798 ) Maturities of available-for-sale securities — 7,600 Net cash (used in) provided by investing activities (2,170 ) 4,802 Financing Activities: Payments of short-term borrowings (10,000 ) — Proceeds from issuance of long-term debt 29,664 — Payments of debt issuance costs (614 ) — Issuance of common stock 803 763 Payments for taxes related to net share settlement of equity awards (888 ) (936 ) Payments for acquisition of in-process research and development (978 ) (500 ) Net cash provided by (used in) financing activities 17,987 (673 ) Effect of exchange rate changes on cash 500 (485 ) Net change in cash and cash equivalents 25,581 (11,079 ) Cash and Cash Equivalents: Beginning of period 18,998 31,153 End of period $ 44,579 $ 20,074 Surmodics, Inc. and Subsidiaries Supplemental Segment Information (in thousands) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Medical Device Revenue Product sales $ 9,299 $ 6,741 $ 25,593 $ 19,970 Royalties 8,220 7,771 23,702 23,015 License fees 25,933 1,024 28,645 3,723 Research, development and other 2,562 1,992 6,799 6,181 Medical Device revenue 46,014 17,528 84,739 52,889 In Vitro Diagnostics Revenue Product sales 6,368 7,178 19,658 20,257 Research, development and other 101 148 217 817 In Vitro Diagnostics revenue 6,469 7,326 19,875 21,074 Total Revenue $ 52,483 $ 24,854 $ 104,614 $ 73,963 Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Operating income (loss): Medical Device $ 21,777 $ (7,308 ) $ 7,483 $ (16,712 ) In Vitro Diagnostics 2,866 3,387 9,450 10,262 Total segment operating income (loss) 24,643 (3,921 ) 16,933 (6,450 ) Corporate (3,231 ) (3,222 ) (9,333 ) (9,034 ) Total operating income (loss) $ 21,412 $ (7,143 ) $ 7,600 $ (15,484 ) Surmodics, Inc. and Subsidiaries Reconciliation of GAAP Measures to Non-GAAP Amounts Schedule of EBITDA and Adjusted EBITDA (in thousands) (Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2023 2022 2023 2022 Net income (loss) $ 7,346 $ (5,651 ) $ (8,230 ) $ (12,546 ) Income tax expense (benefit) 13,303 (1,530 ) 13,506 (3,155 ) Depreciation and amortization 2,151 2,206 6,365 6,902 Interest expense, net 884 145 2,594 410 Investment income, net (182 ) (22 ) (531 ) (73 ) EBITDA 23,502 (4,852 ) 13,704 (8,462 ) Adjustments: Stock-based compensation expense 1,915 1,799 5,662 5,198 Restructuring expense (1) — — 1,282 — Contingent consideration fair value adjustment (2) (829 ) — (829 ) — Adjusted EBITDA $ 24,588 $ (3,053 ) $ 19,819 $ (3,264 ) Surmodics, Inc. and Subsidiaries Guidance Reconciliation: Estimated Non-GAAP Diluted EPS For the Fiscal Year Ending September 30, 2023 (Unaudited) Fiscal 2023 Full-Year Estimate Low High GAAP Diluted EPS $ (0.55 ) $ (0.40 ) Per diluted share: Amortization of acquired intangible assets (3) 0.23 0.23 Restructuring expense (1) 0.09 0.09 Contingent consideration fair value adjustment (2) (0.06 ) (0.06 ) Non-GAAP Diluted EPS $ (0.29 ) $ (0.14 ) Diluted weighted average shares outstanding 14,030 Surmodics, Inc. and Subsidiaries Net Income (Loss) and Diluted EPS GAAP to Non-GAAP Reconciliation (in thousands, except per share data) (Unaudited) Three Months Ended June 30, 2023 Revenue Operating Income Income Before Income Taxes Net Income (4) Diluted EPS GAAP $ 52,483 $ 21,412 40.8 % $ 20,649 $ 7,346 $ 0.52 Adjustments: Amortization of acquired intangible assets (3) — 879 1.7 % 879 813 0.06 Contingent consideration fair value adjustment (2) — (829 ) (1.6 )% (829 ) (829 ) (0.06 ) Non-GAAP $ 52,483 $ 21,462 40.9 % $ 20,699 $ 7,330 $ 0.52 Diluted weighted average shares outstanding (5) 14,072 Three Months Ended June 30, 2022 Revenue Operating Loss Loss Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 24,854 $ (7,143 ) (28.7 )% $ (7,181 ) $ (5,651 ) $ (0.41 ) Adjustments: Amortization of acquired intangible assets (3) — 1,024 4.1 % 1,024 930 0.07 Non-GAAP $ 24,854 $ (6,119 ) (24.6 )% $ (6,157 ) $ (4,721 ) $ (0.34 ) Diluted weighted average shares outstanding (5) 13,929 Nine Months Ended June 30, 2023 Revenue Operating Income Income Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 104,614 $ 7,600 7.3 % $ 5,276 $ (8,230 ) $ (0.59 ) Adjustments: Amortization of acquired intangible assets (3) — 2,659 2.5 % 2,659 2,467 0.18 Restructuring expense (1) — 1,282 1.2 % 1,282 1,282 0.09 Contingent consideration fair value adjustment (2) — (829 ) (0.8 )% (829 ) (829 ) (0.06 ) Non-GAAP $ 104,614 $ 10,712 10.2 % $ 8,388 $ (5,310 ) $ (0.38 ) Diluted weighted average shares outstanding (5) 14,020 Nine Months Ended June 30, 2022 Revenue Operating Loss Loss Before Income Taxes Net Loss (4) Diluted EPS GAAP $ 73,963 $ (15,484 ) (20.9 )% $ (15,701 ) $ (12,546 ) $ (0.90 ) Adjustments: Amortization of acquired intangible assets (3) — 3,184 4.3 % 3,184 2,893 0.21 Non-GAAP $ 73,963 $ (12,300 ) (16.6 )% $ (12,517 ) $ (9,653 ) $ (0.69 ) Diluted weighted average shares outstanding (5) 13,907 (1) Restructuring expense consists of severance and related costs specifically associated with a workforce restructuring implemented in the second quarter of fiscal 2023. (2) Represents accounting adjustments to state acquisition-related contingent consideration liabilities at their estimated fair value as of the period end date, including adjustments to the liabilities’ fair values related to changes in the timing and/or probability of achieving milestones and accretion expense for the passage of time. (3) Represents amortization of business acquisition-related intangible assets and associated tax impact. A significant portion of the business acquisition-related amortization is not tax deductible. (4) Net income (loss) includes the effect of the above adjustments on income tax (expense) benefit, taking into account deferred taxes net of valuation allowances, as well as non-deductible items. Income tax impacts were estimated using the applicable statutory rate (21% in the U.S. and 12.5% in Ireland). (5) Diluted weighted average shares outstanding used in the calculation of EPS was the same for GAAP EPS and Non-GAAP EPS. 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