Surmodics, Inc. (NASDAQ:SRDX) Q1 2024 Earnings Call Transcript

Our guidance, which we are raising today, reflects the financial and operating performance we achieved in the first quarter as well as our continued confidence in the ability to accelerate our revenue growth profile in fiscal ’24 with growth of 10% or higher, excluding license fee revenue related to our SurVeil DCB. We look forward to building on these accomplishments as we progress through the fiscal year, while continuing to focus on cash efficiency, preserving and allocating capital strategically in order to achieve strong sustainable growth and value creation on a long-term basis. I’d like to thank our entire team for their contributions this past quarter and their commitment to advancing the leadership in the markets we serve, as well as our customers and stakeholders for their ongoing support of Surmodics and our mission.

Tim will now review our first quarter financial results of fiscal ’24 guidance in greater detail. Tim?

Tim J. Arens: Thank you, Gary. Unless noted, all references to first-quarter results are on a GAAP and year-on-year basis, total revenue for the first quarter of fiscal 2024 increased $5.6 million or 23% to $30.6 million. Excluding SurVeil DCB license fee revenue, total revenue increased $5.9 million or 25% to $29.6 million. Our earnings press release includes detailed reconciliations of total revenue, excluding SurVeil DCB license fee revenue, product revenue increased $4.6 million or 32% to $18.8 million. Medical device product revenue increased $3.6 million or 43% to $12 million, a record for our medical device business. Product revenue growth was primarily driven by our fulfillment of the initial SurVeil DCB stocking order from Abbott, as well as increased sales of our Pounce thrombectomy device platform.

As a reminder, product revenue from sales of our SurVeil DCB consists of revenue from both the contractual transfer price and estimated profit sharing, the two revenue streams under our development and distribution agreement with Abbott. IVD product revenue increased $1 million or 17% to $6.9 million. Our diagnostics business benefited from strength in our antigen and microarrays slide offerings and benefited from a combination of factors, Gary mentioned earlier, including flu season demand, timing of orders, and the return of more normalized customer purchasing patterns from some of our customers that had taken steps last year to manage COVID-era related elevated inventory levels. Royalty and license fee revenue increased $410,000 or 5% to $9.2 million.

Performance coating royalty and license fee revenue increased $740,000 or 10% to $8.2 million, driven by customer utilization of our Serene coating, and benefiting from a relatively easy comparison in the prior year period. SurVeil drug-coated balloon license fee revenue decreased $330,000 or 25% to $1 million, corresponding to the decrease in TRANSCEND clinical trial costs incurred. R&D Services revenue increased $610,000 or 32% to $2.5 million, the increase was primarily due to increased customer demand for Performance coating services and our Medical Device business which was impacted in the prior-year period by our customer’s supply chain challenges. Moving down the P&L, product gross margin was 53.2% compared to 63% in the prior year period.

Several factors contributed to the adverse mix impact to product gross margin relative to the prior-year quarter. Importantly, sales of our near-term growth catalysts, our SurVeil drug-coated balloon, Pounce, and Sublime products are increasing as a portion of total company product sales. These device products are not yet at scale and product gross margins are impacted by the associated under-absorption and production inefficiencies. IVD product sales also contributed to the adverse mix impact this quarter with increased sales of our distributed antigen products that carry a lower margin profile. In addition, the absorption of fixed overhead costs had an unfavorable impact this quarter relative to the prior year due to a timing-related decrease in production volumes.

R&D expense including costs related to clinical and regulatory activities decreased $4.1 million or 32% to $8.7 million reflecting lower SurVeil DCB clinical costs, the timing of certain projects in our pipeline, and the benefits from the spending reduction plan we implemented during the second quarter of fiscal 2023. SG&A expense decreased $700,000 or 5% to $12.5 million due to lower headcount in our commercial organization compared to the prior year period related to the aforementioned spending reduction plan, as well as the timing of investments in our commercial organization. Our Medical Device business reported an operating loss of $220,000 compared to $7.2 million in the prior-year period, which reflects the operating expense savings from the restructuring and workforce reduction implemented in the second quarter of fiscal 2023 and lower SurVeil DCB clinical expenses, favorability and timing of operating expenditures in the first quarter and broad-based revenue growth.

Our IVD business reported operating income of $3.1 million or 45% of IVD revenue compared to $2.9 million or 50% of IVD revenue in the prior year period. This reflects leverage on product sales growth, partially offset by the adverse mix impact to product gross profit of increased distributed antigen sales. Turning to income taxes, we reported income tax expense of $60,000 compared to an income tax benefit of $170,000 in the prior year period. GAAP net loss was $790,000 or a loss of $0.06 per diluted share compared to a net loss of $7.8 million or a loss of $0.56 per diluted share in the prior year period. Non-GAAP net income was essentially breakeven and consequently, non-GAAP EPS was zero compared to non-GAAP net loss of $7 million or a loss of $0.50 per diluted share in the prior year period.

Non-GAAP adjusted EBITDA was $3.9 million compared to adjusted EBITDA loss of $3.3 million in the prior year period. Adjusted EBITDA includes adjustments for stock-based compensation expense in both periods. Our press release — our earnings press release, includes detailed reconciliations of GAAP to non-GAAP measures. Moving to the balance sheet, we began the first quarter with $45.4 million in total cash and cash equivalents and investments in available-for-sale securities, and ended the quarter with $35.2 million in cash and investments. Total cash used in the first quarter or the decrease in cash and investments was $10.2 million. As we shared on our last earnings call, our first quarter historically requires a higher use of cash to fund our working capital needs such as annual employee bonus payments, and annual prepaid insurance premiums.

During the first quarter, we reported cash used in operating activities of $8.8 million and capital expenditures of 720,000. Long-term debt was unchanged during the first quarter at $29.4 million. As of the end of the first quarter, we had access to approximately $64 million in additional borrowing capacity under our existing credit agreement. Turning now to fiscal 2024 guidance. We updated our fiscal 2024 revenue guidance today to reflect our performance in the first quarter as well as our revised expectations for the remainder of fiscal 2024. We now expect fiscal 2024 total revenue to range from $117 million to $121 million, representing a decrease of 12% to 9%. Excluding SurVeil DCB license fee revenue, we expect revenue to range from $113 million to $117 million representing an increase of 10% to 14%.

This compares to our prior range of $112 million to $117 million or an increase of 9% to 14% over the prior year. SurVeil DCB license fee revenue is expected to be approximately $4 million in fiscal 2024 compared to $29.6 million in fiscal 2023. We now expect fiscal 2024 GAAP loss per diluted share to range from a loss of $1.40 to a loss of $1.10, compared to our prior range of a loss of $1.55 to a loss of $1.20 per share. Non-GAAP loss per diluted share is expected to range from a loss of $1.17 to a loss of $0.87 compared to our prior range of a loss of $1.32 to a loss of $0.97 per share. I’ll now share a few additional considerations for modeling purposes. With respect to our fiscal 2024 total revenue guidance, product revenue is expected to be approximately 60% of total revenue, driven largely by contributions from our product growth catalysts.