Summary of Penumbra FY Conference Call (January 12, 2026) Company Overview - **Company**: Penumbra (NYSE:PEN) - **Founded**: 2004 - **Headquarters**: Alameda, California - **Employees**: Over 4,500 worldwide - **Manufacturing**: All products currently manufactured in California, with plans for expansion in Costa Rica by mid to late 2027 [2][4] Manufacturing and Expansion - **Current Facilities**: Nine buildings in Alameda, with 260,000 sq ft dedicated to manufacturing [3] - **New Facilities**: - Roseville facility: 300,000 sq ft, successful expansion [4] - Costa Rica facility: 330,000 sq ft, expected to open in mid to late 2027 [4] Business Segments - **Thrombectomy**: Focused on growth, with significant market share in mechanical thrombectomy [5][7] - **Embolization**: Both peripheral and neuro embolization segments are growing significantly [5] Market Insights - **Thrombectomy Market**: - Estimated 250,000 patients in the U.S. for arterial thrombectomy [6] - DVT (Deep Vein Thrombosis) represents the largest opportunity with a focus on iliofemoral DVTs [8] - Stroke market has about 200,000 patients, with over 30% penetration [10] - **Emerging Technologies**: Introduction of CAVT (computer-assisted vacuum thrombectomy) is expected to enhance treatment outcomes [11] Clinical Trials and Product Development - **STORM-PE Trial**: - Landmark trial for pulmonary embolism, showing significant safety and efficacy [12][13] - Procedure time was notably low at 25 minutes, with significant improvements in patient outcomes [13][14] - **Regulatory Updates**: Ongoing communication with the FDA regarding product submissions, with no major concerns reported [25] Growth Drivers and Challenges - **Growth Drivers**: - Anticipated recovery in the Chinese market, which had been a headwind [29] - Increased focus on embolization and thrombectomy as separate business units [29] - **Challenges**: - Need to convert physicians from traditional methods to newer technologies [41] - Structural issues in stroke care delivery remain a challenge [62] Financial Performance and Projections - **Margins**: Commitment to achieving 70%+ gross margins, with expectations for continued improvement [64] - **Growth Outlook**: Anticipated mid-teens growth with over 30% growth on the bottom line [26] Conclusion - **Innovation Commitment**: Penumbra emphasizes ongoing innovation and product development to enhance treatment options and patient outcomes [22] - **Market Position**: The company is positioned as a leader in mechanical thrombectomy, with a strong focus on expanding its market share in both thrombectomy and embolization [41][43]

Summary of Penumbra Conference Call Company Overview - **Company**: Penumbra - **Industry**: Medical Technology (Med Tech) Key Points Q3 Performance - Q3 performance in the MO (Mechanical Operations) and access business was exceptionally strong, leading to a reassessment of growth durability by investors [3][4][5] - The sales force was expanded to focus on the growing embolization product line, adding over 50 experienced personnel from related fields [4][5] Product Innovations - The Ruby XL coil was launched, which fills larger spaces faster and has received positive feedback from physicians due to its innovative design [5][6] - The embolization franchise is expected to grow at a pace comparable to the overall business, marking a significant development for Penumbra [14] Market Opportunities - The MMA (Meningeal Artery) embolization procedure is emerging as a significant growth area, with a potential market opportunity estimated at $1 billion [12][14] - The company is seeing growth in the neuro side, particularly in treating cerebral aneurysms, which was previously underutilized [11][12] Clinical Data and Reception - Positive feedback has been received regarding the STORM-PE study, which demonstrated that mechanical thrombectomy with CAVT is superior to anticoagulation [20][21] - The study showed significant safety and efficacy, with procedure times averaging 25 minutes, which is considered groundbreaking in the field [22][52] Changes in Treatment Protocols - The study's results are prompting hospitals to update their treatment protocols, moving away from waiting for clinical deterioration before intervention [34][36] - The RV/LV (Right Ventricle/Left Ventricle) ratio is a critical diagnostic measure influencing treatment decisions, and improvements in this ratio were noted in the study [25][26] Future Outlook - The company is optimistic about the upcoming years, expecting continued growth driven by new products and market acceptance [19][60] - The Thunderbolt product is under FDA review, and while there are thorough questions from the FDA, the company remains confident in its efficacy [55][59] Sales and Market Penetration - The penetration rates for mechanical thrombectomy are currently low, but the new data is expected to change this by encouraging earlier intervention [33][34] - The company is focused on educating referring physicians and updating hospital protocols to facilitate this change [32][45] Product Development - The upcoming 3.0 product version is expected to be faster and result in less blood loss compared to previous versions, enhancing its appeal in clinical settings [49][50] Conclusion - Penumbra is positioned for significant growth with innovative products, strong clinical data, and a proactive approach to changing treatment protocols in the medical technology industry [62]

Core Insights - Penumbra's stock surged after exceeding third-quarter expectations, driven by strong performance in its venous thromboembolism (VTE) platform, which saw a 34% increase in sales in the U.S. [1][2] - The company is gaining market share in pulmonary embolism treatments, supported by positive results from the STORM-PE study, which demonstrated the effectiveness of its Lightning Flash device over traditional blood thinners [2][4] - Overall sales for Penumbra reached $354.7 million in the third quarter, marking an 18% increase and surpassing forecasts [6][7] Sales Performance - The embolization and access (E&A) division outperformed expectations with sales growing 22% to $118.3 million, exceeding forecasts of $103.1 million [3] - Thrombectomy sales increased nearly 16% to $236.4 million, aligning closely with expectations of $236.1 million [3] - Penumbra raised its sales guidance for the year to between $1.375 billion and $1.38 billion, indicating a year-over-year growth of 15% to 16% [7] Future Growth Catalysts - The company is pursuing FDA approval for its Thunderbolt device, which is intended for removing blood clots from the brain, and is optimistic about the regulatory process [4][6] - Analysts suggest that the current revenue mix indicates potential for significant growth in 2026, with ongoing catalysts expected to drive sales [5] - The STORM-PE study results are anticipated to positively influence U.S. VTE growth, further enhancing investor sentiment [2][5]

Financial Data and Key Metrics Changes - The company reported total revenue of $354.7 million for Q3 2025, reflecting a year-over-year growth of 17.8% on a reported basis and 16.9% on a constant currency basis [5][18] - Gross margin improved to 67.8%, an increase of 130 basis points compared to the prior year [6][21] - Operating income was $48.8 million, representing 13.8% of revenue, compared to $40.3 million or 13.4% of revenue in the same period last year [7][23] - Adjusted EBITDA was $66.7 million, or 18.8% of total revenue, compared to $56.7 million or 18.8% in Q3 2024 [23] Business Line Data and Key Metrics Changes - U.S. thrombectomy sales increased by 18.5% year-over-year to $192 million, with the VTE franchise leading overall corporate growth at 34% year-over-year [5][19] - U.S. embolization and access revenue reached $83 million, up 29.2% year-over-year, driven by the RubyXL product [5][20] - International revenue was $79.7 million, a 6.6% increase year-over-year, or 3% in constant currency [6][18] Market Data and Key Metrics Changes - The U.S. market accounted for 77.5% of total sales, while international sales made up 22.5% [18] - The international thrombectomy revenue grew by 5.6% year-over-year, indicating a return to growth after previous headwinds [19] Company Strategy and Development Direction - The company is focused on achieving a gross margin profile of over 70% by the end of 2026 and expects operating margin expansion to outpace gross margin expansion [8][21] - The strategic buildout of a dedicated peripheral embolization sales team has contributed to strong sequential growth in embolization revenue [10][14] - The company is optimistic about the potential impact of the Storm PE trial on clinical practice and patient treatment protocols [10][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term strategy, emphasizing innovation, data generation, and investment in the team to support durable, profitable growth [17] - The company raised its revenue guidance for the year to $1,375 million-$1,380 million, reiterating a 20%-21% year-over-year growth for U.S. thrombectomy [12][24] Other Important Information - The company received FDA clearance for new products, Lightning Bolt 16 and Lightning Flash 3.0, which are expected to enhance its competitive positioning [9][12] - The company has a robust patent portfolio protecting its core CABT technology, with recent legal victories affirming its competitive patents [9] Q&A Session Summary Question: Update on Thunderbolt product approval timeline - Management clarified that Thunderbolt is a new product and the FDA process is thorough, with optimism about the approval timeline but no specific date provided [26][27] Question: Impact of Storm PE trial results on market adoption - Positive reactions from the medical community were noted, with expectations for changes in hospital protocols and increased adoption of CABT technology [30][31] Question: Insights on margins and growth drivers - Management indicated that all CABT products have strong margins and that the new RubyXL product is expected to contribute positively to margins [37][38] Question: Trends in U.S. thrombectomy market growth - Management acknowledged a deceleration in the stroke market but emphasized continued share gains and strong performance in the VTE segment [41][42] Question: International sales and China headwinds - Management indicated that headwinds from China are waning, with expectations for minimal impact moving forward [54][55] Question: DVT market trends and growth expectations - The company expects continued growth in the DVT segment, driven by positive responses to new products and ongoing health economic collaborations [74][76]

Core Insights - Penumbra, Inc. (NYSE:PEN) is recognized as one of the top medical device stocks to invest in, with Needham upgrading its rating from Hold to Buy and setting a price target of $326, driven by expected revenue growth in 2026 [1][2] Revenue Growth Factors - The anticipated revenue growth is attributed to four key factors: the launch of the Ruby XL, findings from the STORM-PE trial, the upcoming Thunderbolt product launch, and reduced headwinds in China [1] - The Thunderbolt product is projected to nearly double Penumbra's revenue per stroke procedure, which is expected to enhance growth in neuro thrombectomy and improve gross margins [2] Company Overview - Penumbra, Inc. is a California-based leader in thrombectomy and vascular intervention technologies, offering products such as the Indigo and Lightning series, along with neuro and vascular embolization solutions [3]

Core Viewpoint - Needham upgraded Penumbra Inc. from Hold to Buy with a price target of $326.00, anticipating significant revenue growth in 2026 driven by key product launches and clinical trial results [1] Group 1: Revenue Growth Drivers - The upcoming Thunderbolt product launch is expected to nearly double Penumbra's revenue per stroke procedure, enhancing growth in neurothrombectomy and improving gross margins [2] - Positive results from the STORM-PE clinical trial are anticipated to support revenue growth [1] - Easing regulatory headwinds in China is expected to facilitate market expansion [1] - The rollout of Ruby XL is also projected to contribute to revenue acceleration [1] Group 2: Financial Projections - Analysts expect improving operating leverage to positively impact consensus earnings estimates for 2026 [2] - A combination of higher sales forecasts and multiple expansion is predicted to support continued appreciation in Penumbra's share price [2]

Upgrades - Seaport Research upgraded Constellation Energy (CEG) to Buy from Neutral with a price target of $407, anticipating more datacenter power deal announcements and positive earnings revisions for thermal IPPs before year-end [2] - Wolfe Research upgraded Otis Worldwide (OTIS) to Outperform from Peer Perform with a price target of $109, noting that downside risk to Q4 outlook is widely anticipated but offsetting positive developments could drive more bullish positioning [3] - JPMorgan upgraded Ionis Pharmaceuticals (IONS) to Overweight from Neutral with a price target of $80, up from $49, citing multiple launches that position the company on a path to breakeven [4] - Needham upgraded Penumbra (PEN) to Buy from Hold with a price target of $326, expecting significant growth acceleration in 2026 due to upcoming product launches and easing headwinds in China [4] - Deutsche Bank upgraded Northrop Grumman (NOC) to Buy from Hold with a price target of $700, up from $575, forecasting strong free cash flow post-2028 as key programs become cash profitable [5] Downgrades - HSBC downgraded Intel (INTC) to Reduce from Hold with a price target of $24, up from $21.25, indicating that while short-term deal announcements may drive stock higher, sustainable turnaround relies on fab execution [6] - JPMorgan downgraded FedEx (FDX) to Neutral from Overweight with a price target of $274, down from $284, based on recent channel checks suggesting a lower multiple for FedEx's freight segment [6] - Oppenheimer downgraded Edwards Lifesciences (EW) to Perform from Outperform with no price target, indicating a structural nature to the downgrade despite potential TAVR upside in Q3 [6] - BofA downgraded Freshpet (FRPT) to Neutral from Buy with a price target of $60, down from $81, citing deteriorating growth in the pet food category due to slowed pet adoptions and reduced consumer spending [6] - Oppenheimer downgraded Incyte (INCY) to Perform from Outperform with a price target of $82, up from $81, due to high expectations for several products and new management [6]

Financial Data and Key Metrics Changes - The company raised its 2025 revenue growth guidance, implying low teens revenue growth in the second half of the year, which indicates a deceleration from mid-teens growth in the first half of the year [9][11] - The underlying guidance of 13 to 14% is more like 17 to 18% when considering a $40 million headwind from China [11] Business Line Data and Key Metrics Changes - The embolization franchise has seen low teens growth, with the introduction of the Ruby XL coil expected to enhance market presence [59][61] - The stroke business has been gaining share and growing above the market, with the new Red 72 Send-It silver label product receiving positive feedback from physicians [40][44] Market Data and Key Metrics Changes - The U.S. pulmonary embolism (PE) market has 157,000 annual patients, with only 11% currently receiving mechanical thrombectomy, indicating significant growth potential if the Storm PE trial results are positive [20][22] - The company is positioned to capture a larger share of the embolization market, particularly with the introduction of new products and a dedicated sales force [61][64] Company Strategy and Development Direction - The company is focused on continued innovation and expanding its commercial footprint to capitalize on the large CAVT opportunity and embolization market [3][4] - Management emphasizes the importance of clinical data and market access initiatives to penetrate new areas and enhance profitability [4][68] Management's Comments on Operating Environment and Future Outlook - Management is optimistic about the next five years, highlighting the importance of innovation and the potential for significant growth in both embolization and stroke markets [3][4][67] - The company is on track to achieve a gross margin of at least 70% by 2026, driven by efficiencies and new facility developments [71] Other Important Information - The Storm PE trial is a pivotal study that could shift treatment paradigms in the PE space, with results expected to be presented at TCT and VIVA [13][15] - The company is not currently facing the $40 million headwind from China next year, which could positively impact growth [65] Q&A Session Summary Question: Why is there a deceleration in revenue growth guidance for the second half of the year? - Management indicated that the updated guidance reflects a cautious approach and does not want to get ahead of itself [9][10] Question: What is the expected impact of the Storm PE trial results? - Positive results could lead to increased referrals for mechanical thrombectomy and a shift in treatment protocols among hospital systems [22][37] Question: How is the company addressing the challenges in the stroke market? - The strategy focuses on quick access to clots and the introduction of innovative products to enhance treatment efficacy [40][42] Question: What are the expectations for the embolization business moving forward? - The introduction of the Ruby XL coil and a dedicated sales force are expected to drive growth in the embolization market [59][61] Question: What is the outlook for gross margin and profitability? - Management is confident in achieving a gross margin of at least 70% by 2026, supported by operational efficiencies and new product introductions [71][72]

Financial Data and Key Metrics Changes - The company raised its 2025 revenue growth guidance, implying low teens revenue growth in the second half of the year, which indicates a deceleration from mid-teens growth in the first half of the year [9][11] - The underlying guidance of 13 to 14% is more like 17 to 18% when considering the impact of a $40 million headwind from China [11] Business Line Data and Key Metrics Changes - The embolization franchise is expected to ramp up, with the introduction of the Ruby XL coil targeting a previously untapped 20% of the overall embolization market [61][63] - The stroke business has seen a positive response to the new Red 72 Send-It silver label product, which has gained market share in Q2 [40][44] Market Data and Key Metrics Changes - The company noted that the U.S. has approximately 157,000 annual PE patients, with only 11% currently receiving mechanical thrombectomy, indicating significant growth potential if the Storm PE trial results are positive [21][22] - The stroke market has been described as experiencing regular ebbs and flows, with the company gaining share and growing above the market despite recent fluctuations [44][46] Company Strategy and Development Direction - The company is focused on continued innovation and expanding its commercial footprint to capitalize on large market opportunities in CAVT and embolization [3][4] - The management emphasized the importance of clinical data and market access initiatives to penetrate new areas and enhance profitability [4] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the next five years, highlighting the importance of new product launches and clinical data in driving growth [3][4] - The company is confident about its position to help more patients in the coming years, driven by innovation and data [69] Other Important Information - The company is on track to achieve a gross margin of at least 70% by 2026, with ongoing efforts to improve profitability through efficiencies and new facilities [73] Q&A Session Summary Question: Why is the second half growth expected to slow? - Management indicated that the updated guidance reflects a cautious approach and does not want to get ahead of itself [9][10] Question: What is the significance of the Storm PE trial? - The Storm PE trial aims to compare mechanical thrombectomy versus anticoagulation, which could shift treatment paradigms if results are positive [12][14] Question: How does the company view the embolization opportunity? - The company sees significant potential in the embolization market, especially with the introduction of the Ruby XL coil [61][63] Question: What is the outlook for the stroke market? - Management noted that the stroke market has regular ebbs and flows, but the company has been gaining share and expects continued growth [44][46] Question: What are the expectations for next year? - Management is optimistic about next year, citing the absence of the China headwind and the potential impact of new innovations [67][69]

Financial Data and Key Metrics Changes - The company raised its 2025 revenue growth guidance, implying low teens revenue growth in the second half of the year, which indicates a deceleration from mid-teens growth in the first half of the year [9][11] - The underlying guidance of 13 to 14% is more like 17 to 18% when considering a $40 million headwind from China [11] Business Line Data and Key Metrics Changes - The embolization franchise has seen low teens growth, with the introduction of the Ruby XL coil expected to enhance market presence [61] - The stroke business has been gaining share and growing above the market, with the new Red 72 Send-It silver label product receiving positive feedback [40][44] Market Data and Key Metrics Changes - The U.S. pulmonary embolism (PE) market has 157,000 annual patients, with only 11% currently receiving mechanical thrombectomy, indicating significant growth potential if the Storm PE trial results are positive [21][22] - The company is positioned to capture a larger share of the embolization market, particularly with the new XL product line targeting larger vessels [61] Company Strategy and Development Direction - The company is focused on continued innovation and expanding its commercial footprint to capitalize on the CAVT and embolization opportunities [3][4] - There is a strategic emphasis on profitability and efficiency, with a goal to exit 2026 with at least a 70% gross margin [73] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the next five years, highlighting the importance of clinical data and market access initiatives to penetrate new areas [4][70] - The company is confident about its position moving into next year and beyond, driven by new innovations and data [69] Other Important Information - The Storm PE trial is a pivotal study that could significantly influence the treatment paradigm for PE if results are positive, with primary endpoints to be presented at TCT [13][14] - The company is actively working on a new facility in Costa Rica, which is expected to contribute to margin expansion [73] Q&A Session Summary Question: Why is there a deceleration in growth guidance for the second half of the year? - Management indicated that the updated guidance reflects a cautious approach and does not want to get ahead of itself [9][10] Question: What is the expected impact of the Storm PE trial? - Positive results could lead to increased referrals for mechanical thrombectomy and a shift in treatment protocols [22][24] Question: How is the company addressing the stroke market? - The strategy focuses on quick access to clots and the introduction of innovative products like modulated aspiration to improve treatment outcomes [40][41] Question: What are the expectations for the embolization business? - The introduction of the Ruby XL coil is expected to drive growth, with a new sales team in place to support this initiative [61][63] Question: What is the outlook for next year? - Management is optimistic about growth potential, especially with the absence of the China headwind and the introduction of new products [67][69]