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Sep 30, 2022
Surmodics Q4 2022 Earnings Report
Surmodics reported an 8% increase in total revenue, driven by a 12% increase in Medical Device revenue, and submitted a complete response to FDA comments on its SurVeil drug-coated balloon application.
Key Takeaways
Surmodics reported an 8% increase in total revenue for the fourth quarter of fiscal year 2022, driven by growth in Medical Device revenue. Progress was made on strategic objectives, including the submission of a complete response to FDA comments for the SurVeil drug-coated balloon.
Total revenue increased by 8% year-over-year to $26.0 million.
Medical Device revenue increased by 12% year-over-year, driven by product sales and licensing fee revenue.
GAAP Diluted EPS was $(1.06), including $(0.73) deferred tax valuation reserve.
Non-GAAP Diluted EPS was $(0.26).
Surmodics
Surmodics
Surmodics Revenue by Segment
Revenue by Segment
Medical Device Revenue
CapyFin.comIn Vitro Diagnostics Revenue
CapyFin.com Forward Guidance
Surmodics expects fiscal year 2023 total revenue to range from $103 million to $107 million, representing an increase of 3% to 7% compared to the prior year. The Company expects fiscal 2023 GAAP diluted loss per share to range from $(2.80) to $(2.40).
Positive Outlook
- Fiscal year 2023 total revenue expected to increase by 3% to 7% compared to the prior year.
- The potential revenue during fiscal 2023 associated with the $30 million, $27 million or $24 million milestone payment would be approximately $27 million, $25 million or $22 million, respectively.
- New credit agreement with MidCap Financial, comprised of up to $100 million in term loans and a $25 million revolving credit facility.
- Continued investment to support the commercialization of the Company’s Pounce thrombectomy and Sublime radial access products
- Surmodics has the potential to receive up to a $30 million milestone payment during fiscal 2023 pursuant to the Abbott Development and Distribution Agreement related to premarket approval (“PMA”) by the U.S. Food and Drug Administration (“FDA”) of the SurVeil DCB.
Challenges Ahead
- Fiscal 2023 GAAP diluted loss per share to range from $(2.80) to $(2.40).
- Non-GAAP diluted loss per share in fiscal 2023 is expected to range from $(2.54) to $(2.14).
- The milestone payment is reduced to $27 million if PMA is received after December 31, 2022, but before June 30, 2023, and to $24 million if PMA is received on or after June 30, 2023.
- The Company does not expect to receive the PMA prior to January 1, 2023.
- Revenue from regulatory-related milestones is not included in guidance until after they are achieved.
Revenue & Expenses
Visualization of income flow from segment revenue to net income