Financial Data and Key Metrics Changes - Total revenue for the second quarter of 2025 was $339,500,000, representing a year-over-year growth of 13.4% on a reported basis and 12.7% on a constant currency basis [6][19] - Gross margin for the second quarter was 66%, up from 54.4% in the same quarter of 2024, which included a one-time $33,400,000 inventory write-off [22][23] - Operating income was $40,800,000, or 12% of revenue, compared to an operating loss of $1,600,000 for the same period last year [25][26] - Adjusted EBITDA was $61,400,000, or 18.1% of total revenue, compared to $13,000,000, or 4.3%, in the second quarter of the previous year [26] Business Line Data and Key Metrics Changes - U.S. Thrombectomy revenue increased by 22.6% year-over-year to $188,500,000, driven by a 42% growth in the USVTE franchise [8][19] - Global thrombectomy business revenue grew to $230,300,000, an increase of 13.1% reported and 12.6% in constant currency [21] - Revenue from the Embolization and Access business was $109,200,000, an increase of 13.9% reported and 12.8% in constant currency, primarily driven by U.S. Embolization sales [22] Market Data and Key Metrics Changes - The U.S. region reported growth of 19.5%, driven by the strong performance of the thrombectomy franchise [20] - International regions saw a decrease of 3.2% reported and 5.8% in constant currency, primarily due to a decline in China revenue [20] - Excluding the impact of the China region, international thrombectomy revenue grew by 14.4% compared to the same period last year [21] Company Strategy and Development Direction - The company is focused on continuous innovation and expanding the total number of patients treated globally with its technologies [6][7] - A separate peripheral embolization sales force has been established to enhance focus on thrombectomy and embolization, with over 50 new sales representatives added [11] - The company aims to achieve a gross margin profile of over 70% by 2026, with operating margin expansion expected to outpace gross margin expansion [9][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about easing headwinds in China, anticipating a return to growth across all international regions [20] - The company is committed to running high-quality clinical studies to support its product offerings and market access initiatives [12][17] - Management highlighted the importance of the STORM PE trial, which is expected to provide significant evidence for the treatment of pulmonary embolism [12][34] Other Important Information - The company ended the second quarter with cash, cash equivalents, and marketable securities of $424,600,000 and no debt, reflecting strong operating profitability [26] - Due to outperformance in the second quarter, the company increased its revenue guidance for 2025 to a range of $1,355,000,000 to $1,370,000,000, representing 13% to 15% year-over-year growth [27] Q&A Session Summary Question: Importance of STORM PE study - Management emphasized that STORM PE is the first randomized study comparing anticoagulation and mechanical thrombectomy, which is significant for the field [32][34] Question: Update on Thunderbolt FDA review - Management stated that the FDA review process is thorough and ongoing, and they remain excited about the product's potential impact [38][39] Question: Impact of Salesforce split on margins - Management clarified that the investment in the commercial team does not impact gross margins but is expected to support long-term margin goals [52][54] Question: Anticipated slowdown in U.S. thrombectomy business - Management acknowledged a potential deceleration in the stroke market but remains optimistic about continued growth in the thrombectomy business [48][72] Question: International market performance and China - Management noted that international markets are beginning to show signs of recovery, particularly with the launch of new products [80][82]

Core Viewpoint - Penumbra, Inc. will host a conference call to discuss its financial results for the second quarter of 2025 on July 29, 2025, at 4:30 PM Eastern Time, with a press release to follow after market close on the same day [1]. Group 1: Conference Call Details - The conference call can be accessed via phone at (888) 596-4144 with conference ID 6572573, or through a webcast available on the company's website [2]. - The webcast will remain accessible on the company's website for at least two weeks after the call [2]. Group 2: Company Overview - Penumbra, Inc. is recognized as the world's leading thrombectomy company, focusing on innovative technologies for medical conditions such as ischemic stroke and venous thromboembolism [3]. - The company's portfolio includes computer-assisted vacuum thrombectomy (CAVT), aimed at efficiently removing blood clots from various parts of the body [3]. - Penumbra supports healthcare providers in over 100 countries, striving to enhance patient outcomes and quality of life [3].

Core Insights - Penumbra, Inc. has completed enrollment in the STORM-PE clinical trial, which is a pioneering study comparing computer-assisted vacuum thrombectomy (CAVT™) using Penumbra's Lightning Flash™ with anticoagulation versus anticoagulation alone for treating acute intermediate-high risk pulmonary embolism [1][2] - The trial enrolled 100 patients and aims to provide high-quality evidence on the effectiveness of CAVT in improving right heart function and clinical outcomes in patients with pulmonary embolism [1][2][4] - Pulmonary embolism is a significant health concern, with an estimated 900,000 symptomatic cases occurring annually in the U.S., and a mortality rate of 10-30% within one month of diagnosis [3] Company Overview - Penumbra, Inc. is recognized as the world's leading thrombectomy company, focusing on innovative technologies for medical conditions such as ischemic stroke and venous thromboembolism [6] - The company's Lightning Flash portfolio features advanced mechanical thrombectomy systems designed to remove blood clots efficiently, utilizing dual clot detection algorithms and a specialized catheter design [4][6] - Penumbra operates in over 100 countries, aiming to enhance patient outcomes and quality of life through its innovative medical solutions [6]

Core Viewpoint - Penumbra has demonstrated strong share price performance, increasing by 35.9% over the past year, significantly outperforming the industry which saw a decline of 13.3% [1] Company Performance - Penumbra's thrombectomy business is experiencing robust growth, with a year-over-year increase of 25% in the first quarter of 2025, driven by the adoption of its CAVT portfolio and new product launches [5] - The international thrombectomy revenues grew by 18.2% year-over-year, particularly strong in regions outside China, indicating potential for future growth [6] - The company has a solid financial position, exiting the first quarter of 2025 with cash and cash equivalents of $379 million, an increase from $340 million in the previous quarter [7] Product Development and Market Adoption - The growth in share price is attributed to consistent revenue growth, particularly from the Lightning Flash and Lightning Bolt product lines, which have shown extraordinary patient outcomes [4] - The recent launch of the RED 72 catheter has received positive clinical uptake, reinforcing Penumbra's leadership in stroke care [5] Future Projections - The Zacks Consensus Estimate predicts a 69.8% increase in earnings per share (EPS) for 2025, with revenues projected to grow by 13.4% to $1.35 billion [11]

Financial Data and Key Metrics Changes - The company reported total revenue of $324.1 million for Q1 2025, reflecting a year-over-year growth of 16.3% on a reported basis and 16.9% on a constant currency basis [10][26] - Gross margin improved to 66.6%, an increase of 160 basis points compared to the prior year [11][30] - Operating income reached $40.4 million, or 12.4% of revenue, up 550 basis points year-over-year [11][33] - Adjusted EBITDA was $59.6 million, representing 18.4% of total revenue, compared to $36.3 million or 13.5% in the same quarter last year [33] Business Line Data and Key Metrics Changes - U.S. thrombectomy revenue increased by 25% year-over-year to $187.9 million, with the USVTE franchise leading with a growth of 42% [10][26] - Revenue from the global thrombectomy business grew to $226.5 million, a 20.7% increase reported and 21.2% in constant currency [28] - The embolization and access business reported revenue of $97.6 million, a 7.3% increase reported and 8.1% in constant currency [30] Market Data and Key Metrics Changes - Sales from the U.S. accounted for 79.2% of total revenue, while international sales made up 20.8% [26] - International revenue decreased by 2.5% reported and 0.1% in constant currency, primarily due to a decline in China revenue of $6.7 million [27] - The company expects continued year-over-year headwinds from the China business for Q2 2025 [29] Company Strategy and Development Direction - The company aims to achieve a gross margin profile of over 70% by the end of 2026 [11] - Continuous innovation is a key strategy, with a focus on enhancing the proprietary CABT portfolio and investing in embolization and access portfolios [15][16] - The company is expanding market access initiatives to increase awareness of CABT's clinical and economic benefits [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong market position and growth potential, particularly in the U.S. thrombectomy business [10][23] - The company reiterated its total revenue guidance for the year at 12% to 14% year-over-year growth, while raising the U.S. thrombectomy growth guidance to 20% to 21% [35] - Management acknowledged the impact of macroeconomic conditions, particularly in China, but remains optimistic about overall growth [27][29] Other Important Information - The company ended Q1 2025 with cash, cash equivalents, and marketable securities of $378.8 million and no debt [34] - The FDA clearance for Ruby XL, a new diagnostic catheter-compatible peripheral coil, was received earlier than expected, with plans for market launch in late Q2 or early Q3 [16][17] Q&A Session Summary Question: Can you provide more color on stroke versus peripheral market trends? - Management noted significant growth in the stroke business, driven by the launch of the new Red 72 catheter, and emphasized that the stroke business is performing well above market growth [40][41] Question: How are you thinking about R&D spending going forward? - Management indicated that R&D spending is not linear and will continue to invest in innovation, with savings from the immersive business wind down contributing to lower R&D expenses this quarter [45][50] Question: What are the key metrics for the Thunderbolt product? - Management stated that the Thunderbolt product is submitted as a 510(k) and emphasized the importance of procedure time and device engagement time as key metrics for physicians [56][58] Question: What is the impact of the new thrombolytic agent on thrombectomy demand? - Management believes that the new drug targets different patient populations and does not see it impacting thrombectomy demand significantly [117] Question: Can you discuss the growth in international markets outside of China? - Management confirmed strong growth in international markets where CABT is available, but noted that the U.S. will continue to drive most of the growth due to its larger market size and reimbursement dynamics [71][73]

Company Overview - Surmodics (SRDX) has launched the Pounce XL Thrombectomy System, enhancing its vascular intervention solutions portfolio aimed at efficient clot removal in larger vessels [1][4] - The Pounce XL is designed for arteries ranging from 5.5 to 10 mm in diameter, expanding the capabilities of the existing Pounce Thrombectomy Platform [6][8] Product Details - The Pounce XL Thrombectomy System utilizes proprietary dual-basket technology for clot removal, minimizing blood loss and reducing risks associated with traditional methods [9][10] - Clinical data indicates an average procedural time of 20.3 minutes and a high success rate of 79.7% for patients requiring no additional clot removal treatment [10] Market Position and Financials - Following the announcement, SRDX shares fell by 2.1%, closing at $30.11, with a year-to-date decline of 24% compared to the industry’s growth of 7.1% [3] - SRDX currently has a market capitalization of $439.7 million and reported an earnings surprise of 50% in the last quarter [5] Industry Trends - The global thrombectomy devices market is projected to grow from $1.52 billion in 2023 to approximately $3.09 billion by 2033, with a CAGR of 7.33% from 2024 to 2033 [11] - The increasing prevalence of cardiovascular diseases is driving demand for thrombectomy procedures, highlighting the need for effective clot removal solutions [12]

Core Insights - Surmodics, Inc. (SRDX) reported a strong performance in the last quarter, with a loss per share that was 51.9% narrower than market estimates and sales exceeding estimates by 8.3%, driven by solid prospects in the thrombectomy business [1][3] - The company is likely to be acquired by GTCR for an estimated total equity valuation of $627 million, with the deal expected to close by the end of March, potentially offering double-digit returns for investors [2][5] - Surmodics has a market capitalization of $404.58 million and projects a remarkable 162.5% growth for fiscal 2025, maintaining a strong performance trajectory [3] Acquisition Details - Surmodics entered into a definitive agreement in May 2024 to be acquired by GTCR, with shareholders set to receive $43.00 per share in cash [5] - The acquisition faces challenges as the FTC has blocked the deal due to anti-competitive concerns, prompting Surmodics to consider legal action against the FTC [5][11] Financial Performance - Surmodics demonstrated solid improvement in both top and bottom lines for Q1 of fiscal 2025, with notable increases in performance coatings royalty revenues and sales from the Pounce thrombectomy device platforms [8] - The gross margin expansion is a positive indicator for the stock, despite some segmental sales declines attributed to unfavorable order timing [10] Thrombectomy Business Prospects - The company aims to leverage its proprietary Pounce thrombectomy platform technology, with early results from a study presented at the TCT Symposium and FDA clearance for the Pounce XL Thrombectomy System [7] - Limited market evaluations of the product are expected to generate additional revenues during fiscal 2025 [7] Estimate Trends - Surmodics is experiencing a positive estimate revision trend for fiscal 2025, with the Zacks Consensus Estimate for earnings per share improving by 1 cent to 19 cents [13] - The consensus estimate for Q2 fiscal 2025 revenues is projected at $33 million, indicating a 3.3% increase from the previous year [13]

Financial Data and Key Metrics Changes - In Q4 2024, the company generated revenue of $321.3 million, representing a year-over-year growth of 12.9% on an adjusted basis and 13% on a constant currency basis [9][29] - Full year 2024 revenue increased 13.4% year-over-year to over $1.2 billion, with U.S. thrombectomy business revenue of $646.7 million, a 26.8% increase versus 2023 [10][34] - Gross margin for Q4 2024 was 67.4%, an improvement of 170 basis points compared to the prior year, while operating income was $48.6 million, or 15.1% of revenue, up 200 basis points year-over-year [12][33] Business Line Data and Key Metrics Changes - U.S. thrombectomy sales in Q4 increased 27.3% year-over-year to $180.6 million, with the U.S. VTE franchise delivering robust growth of 41% [9][10] - Revenue from the global thrombectomy business grew to $222.7 million in Q4 2024, an increase of 16.8% adjusted and 16.9% in constant currency [31] - The embolization and access business reported revenue of $98.6 million in Q4 2024, a 5% increase adjusted and 5.1% in constant currency [32] Market Data and Key Metrics Changes - The geographic mix of sales for Q4 2024 was 77.2% U.S. and 22.8% international, with U.S. growth of 21.7% driven by thrombectomy franchise growth [29] - International regions saw a decrease of 9.4% adjusted and 9.1% in constant currency, primarily due to a decline in China revenue of $15.4 million [30] Company Strategy and Development Direction - The company is focused on expanding its interventional business and has exited the Immersive Healthcare segment to concentrate on thrombectomy innovations [11] - Plans to achieve a gross margin profile over 70% by the end of 2026, leveraging product mix shifts and operational efficiencies [13][41] - The company aims to continue driving gross margin expansion and operating efficiencies while investing in innovation and clinical data [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds in 2024 but expressed confidence in overcoming these challenges in 2025, particularly with the expected growth in the U.S. thrombectomy business [46][47] - The company is optimistic about the potential of its CAVT technology and its ability to capture a larger market share in the thrombectomy space [25][122] Other Important Information - The company ended Q4 2024 with cash, cash equivalents, and marketable securities of $340.1 million and no debt, reflecting strong operating profitability [38] - The company plans to build a manufacturing facility in Costa Rica to enhance manufacturing capacity [13] Q&A Session Summary Question: Guidance for 2025 and Thunderbolt - Management provided guidance for 2025 revenue growth of 12% to 14%, citing caution due to factors like the Thunderbolt product and previous headwinds [45][46] Question: Embolization and Access Business Outlook - Management indicated that the embolization and access business remains strong, with opportunities for growth, particularly in the U.S. [54][56] Question: U.S. Venous Thrombectomy Growth Durability - Management noted that the 41% growth in the U.S. venous thrombectomy business is driven by the effectiveness of CAVT technology and the expansion of the commercial team [60][62]