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Penumbra, Inc.
4/23/2025
would now like to introduce Ms. Cecilia Furlong, Business Development and Investor Relations for Penumbra. Ms. Furlong, you may begin your conference.
Thank you, Operator, and thank you all for joining us on today's call to discuss Penumbra's earnings release for the first quarter of 2025. A copy of the press release and financial tables, which includes a gap to non-gap reconciliation, can be viewed under the Investors tab on our company website at www.penumbrainc.com. During the course of this conference call, the company will make forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our financial performance, commercialization, clinical trials, regulatory status, quality, compliance, and business trends. Actual results could differ materially from those stated or implied by our forward-looking statements due to certain risks and uncertainties including those referenced in our 10-K for the year ended December 31st, 2024, filed with the SEC. As a result, we caution you against placing undue reliance on these forward-looking statements, and we encourage you to review our periodic filings with the SEC, including the 10-K previously mentioned, for a more complete discussion of these factors and other risks that may affect our future results or the market price of our stock. Penumbra disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments, or otherwise. On this call, financial results for revenue and gross margin are presented on a GAAP basis, while operating expenses, operating income, and adjusted EBITDA are presented on a non-GAAP basis. The corresponding GAAP measures and a reconciliation of GAAP to non-GAAP financial measures are provided in our posted press release. Non-GAAP operating expenses and operating income exclude amortization of acquired intangible assets of $2.4 million and non-recurring litigation-related expenses of $4.8 million in the first quarter of 2024. An adjusted EBITDA excludes such non-recurring litigation-related expenses, stock compensation expense, depreciation and amortization, provision for income taxes and interest income expenses. Adam Elsesser, Penumbra's chairman and CEO, will provide a business update. Maggie Yuen, our chief financial officer, will then discuss our financial results for the first quarter of 2025. And Jason Mills, our executive vice president of strategy, will discuss our 2025 guidance. With that, I would like to turn over the call to Adam Elsesser.
Thank you, Cecilia. Good afternoon. Thank you for joining Penumbra's first quarter 2025 conference call. In the first quarter, we generated total revenue of $324.1 million, representing underlying year-over-year growth of 16.3% on a reported basis and 16.9% on a constant currency basis. Our first quarter performance reflected continued momentum across our core U.S. thrombectomy business with the clinical benefits of our differentiated and proprietary CAVT technology, helping us further enhance our strong market position. First quarter U.S. thrombectomy revenue increased 25% year-over-year to $187.9 million, with our U.S. VTE franchise once again leading the business with total year-over-year growth of 42%. Our arterial and stroke businesses also delivered strong growth as those products continue to take share from open surgery and competitive stroke catheters, respectively. Our strong top-line results, coupled with our focus on delivering profitable growth and an expanding profitability profile, resulted in another solid quarter of operating cash flow. In the first quarter, gross margin of 66.6% expanded 160 basis points over the prior year period, while operating income of $40.4 million, or 12.4% of revenue, increased 550 basis points over the year-ago period. We remain on track and are well-positioned to achieve a gross margin profile of over 70% by the end of 2026. I'd like to address the question of proposed or enacted tariffs and the current macro backdrop. We currently manufacture 100% of our products in the United States in our manufacturing facilities in Alameda and Roseville, California. In addition, approximately three quarters of our raw materials and components are currently sourced in the United States. We're also engaged in a regular ongoing process of optimizing our supply chain, which includes among other things, the strategic onshoring of certain materials that are not currently sourced in the United States. In the quarter, sales from the US accounted for 79.2% of total revenue. Regarding China specifically, there was only $5 million included in our original forecast for the balance of the year, which we are now excluding given the current macro environment. Turning to our U.S. peripheral business, in the quarter, we delivered strong sequential expansion from the fourth quarter in the total number of VTE patients treated with our technology. Our strong first quarter results underscore Flash 2.0's durable growth and momentum in VTE, with 2.0's demonstrated value proposition continuing to drive conversions from anticoagulation, lytics, and other mechanical thrombectomy platforms to CAVT for both PE and DVT. The recent addition of Lightning Bolt 12 to the portfolio further augments our competitive positioning, with Bolt 12 contributions exceeding expectation in its first full quarter on the market. Our U.S. arterial business also delivered a solid first quarter, with a combination of continued strong growth in Bolt 7, and ramping ahead of expectations contributions from bolt 6x together driving physician conversion from open surgery or the use of lytics to cabt continuous and rapid innovation is a key tenant of our strategy and a strong competitive differentiator our first priority is continuing to enhance and expand the reach of our proprietary CAVT portfolio. We view our forthcoming new products as significant, and we believe they will continue to drive a paradigm shift in how clot is addressed and treated. That said, we will also invest in further innovation across our embolization and access portfolios. In mid-March, we received FDA clearance for Ruby XL, a new larger size diagnostic catheter compatible peripheral coil. Ruby XL will further augment our existing peripheral embolization portfolio, expanding our market leadership into larger vessel anatomies. Ruby XL will be utilized to address conditions such as pelvic congestion, endo leaks, and tips varices to name a few. FDA clearance of Ruby XL came earlier than we expected, So we have commenced an expedited inventory build to support a market launch in either late Q2 or early Q3 in order to quickly meet the high interest in the product we have seen from physicians to date. As we further expand our product portfolio, we will strategically invest in our commercial team in a measured way to support and enhance focus on the large market opportunities we're addressing. positioning our commercial team for success. We continue to expand and leverage our market access initiatives to increase awareness around CAVT's clinical as well as health economic benefits. At the SIR Annual Scientific Meeting in Nashville at the end of March, two additional retrospective analyses focused on DVT and ALI management with CAVT were presented. Relative to anticoagulation and open surgery for the treatment of DVT and ALI respectively, these analyses demonstrated CAVT's ability to reduce hospital length of stay as well as improve the rate of patient discharge to the home setting, a positive for both the patients treated with CAVT as well as for the healthcare systems. The health economic data that are part of these studies is being shared with hospital executives. We are in the early stages of leveraging our market access initiatives to highlight CAVT's myriad benefits versus alternative interventional options as well as anticoagulation. We will continue to invest in and grow our body of clinical evidence and build upon our efforts to drive further adoption of our CAVT technology and reach this substantial number of patients globally who suffer from clot burden anywhere in the body. Shifting to our neurovascular business, our US stroke thrombectomy franchise delivered another solid quarterly performance with the clinical and procedural benefits of our market leading aspiration portfolio, supporting volume growth ahead of our expectations and the market. The commercial introduction late in the first quarter of our next generation Red 72 catheter, nicknamed Silver Label, was met with significant physician enthusiasm. Silver Label has seen strong interest, adoption, and utilization to date with our R&D team's continued focus on technology innovation delivering a meaningful enhancement in trackability. With Silver Label, we are continuing to move the mechanical aspiration field forward and raise the bar for catheter trackability. While with Thunderbolt, we see an additional meaningful opportunity to address and improve the speed with which clot is extracted in a safe and simple procedure, further expanding our already dominant market leadership position. Regarding our THUNDER trial, in the first quarter of 2025, we submitted the clinical data to the FDA for review. We will provide additional future updates as appropriate and remain excited to introduce CAVT to the neurovascular field. We entered 2025 with significant momentum across our business that sustained into the first quarter of the year, led by our CAVT portfolio and its strong value proposition. Our focus on continuous innovation, generation of high quality clinical and health economic data and strategic investments in our commercial team positions us to deliver durable growth alongside increasing profitability and expand upon our position as the leading global thrombectomy company. I'll now turn the call over to Maggie to go over our financial results for the first quarter of 2025.
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