Financial Data and Key Metrics Changes - The company reaffirmed its guidance for fiscal 2026, indicating a significant step-up in financial performance expected in Q4 [4][6] - The company has seen improvements in household penetration, baseline volume, distribution, and market shares, which are critical for sustainable growth [5] Business Line Data and Key Metrics Changes - In North America Retail, investments in brand remarkability are resonating with consumers, leading to improved household penetration and baseline growth [5] - The Pet segment is also experiencing growth, particularly in the fast-growing cat feeding portfolio [5] Market Data and Key Metrics Changes - The company is maintaining competitiveness in North America Foodservice and International markets, although there is acknowledgment of ongoing challenges [5] - The company plans to enhance margins and focus on key global platforms, including super premium ice cream and pet food, following the divestiture of its Brazil business [6][7] Company Strategy and Development Direction - The company is focused on improving organic sales results while maintaining industry-leading margins and efficiency [7] - The divestiture of the Brazil business is part of a broader strategy to prioritize resources on brands with the strongest growth potential [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategy and progress made, with expectations for improved performance in Q4 and fiscal 2027 [8] - The company is aware of the need to adapt to a more stressed consumer environment compared to pre-COVID times, which has influenced promotional activities [38] Other Important Information - The company is experiencing a significant gap in retailer inventory in the Pet segment, which is expected to be neutral in Q4 [71] - The company is also focusing on enhancing on-shelf availability and marketing execution to improve product turns [30][61] Q&A Session Summary Question: Expectations for volume growth in fiscal 2027 - Management aims to increase competitiveness in dollar terms and maintain pound share while focusing on innovation and marketing [13][15] Question: Competitive landscape and pricing mix - The company has seen a slight increase in price mix due to brand innovation and adjustments in pricing strategy [18][19] Question: Performance of new products - New product innovation is tracking at about 25% growth, with strong performance in North America Retail [23][24] Question: Challenges in the snacks segment - The decline in the snacks segment is primarily attributed to issues with the hot snacks category, particularly Totino's [64][65] Question: Retailer inventory adjustments - The company has seen fluctuations in retailer inventories, particularly in the Pet segment, which is expected to revert in Q4 [71][72] Question: Inflation and cost pressures - Management anticipates inflation pressures to remain in line with the current year, with labor being a significant component [47][48] Question: Gross margin expectations for fiscal 2027 - Management believes stable volume growth will aid in restoring margins, but specific guidance on margin levels is not yet provided [41][42]

Financial Data and Key Metrics Changes - The company reaffirmed its guidance for fiscal 2026, indicating a significant step-up in financial performance expected in Q4 [4][6] - The company has seen strength in household penetration, improved baseline volume, distribution, and market shares, which are critical for sustainable growth [5][6] - The company expects meaningful improvements in both top line and bottom line performance in Q4 and beyond [6][8] Business Line Data and Key Metrics Changes - In North America Retail, investments in brand remarkability are resonating with consumers, leading to a rebuild in household penetration and baseline growth [5][6] - The Pet segment is also adding households and accelerating growth through the Love Made Fresh initiative [5][6] - The company is maintaining competitiveness in North America Foodservice and International markets, although there is acknowledgment of more work ahead [5][6] Market Data and Key Metrics Changes - The company is experiencing a decline in food service volumes, particularly in bakery flour, which is expected to persist in the near term [54][56] - The company noted that commercial traffic is down slightly, while non-commercial traffic has increased [54] Company Strategy and Development Direction - The company is focusing on divesting its Brazil business to prioritize resources on brands and platforms with stronger growth potential [6][7][83] - The goal for fiscal 2027 is to improve organic sales results while maintaining industry-leading margins and efficiency [7][8] - The company is committed to enhancing its innovation and renovation efforts, particularly in North America Retail and Pet segments [14][25] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that consumers are under more stress than in previous years, impacting promotional activity and price mix [36][37] - The company expects to see improvements in gross margins as volume stabilizes and productivity initiatives take effect [40][41] - Management is optimistic about the potential for improved dollar share competitiveness in fiscal 2027 [14][15] Other Important Information - The company is experiencing inflationary pressures, particularly in labor costs, which are expected to continue into fiscal 2027 [45][46] - The company is implementing a multi-year transformation initiative aimed at improving productivity and margin stability [41][46] Q&A Session Summary Question: Can General Mills return to volume growth in fiscal 2027? - Management indicated that the goal is to increase competitiveness in dollar terms while maintaining pound share, with a focus on innovation and marketing [12][13] Question: What is the outlook for price mix in key categories? - Management noted that price mix has been positive, with expectations for growth in fiscal 2027 as pricing gaps close [16][18] Question: How is the innovation tracking against goals? - Management reported that innovation is tracking at about 25% growth in North America Retail, with strong performance from new products [22][23] Question: What are the expectations for gross margins in fiscal 2027? - Management stated that stable volume growth is essential for restoring margins, with a path to improvement expected [40][41] Question: What are the inflation expectations for fiscal 2027? - Management anticipates inflation pressures to remain in line with the current year, with labor costs being a significant factor [45][46] Question: What is the status of the Love Made Fresh initiative? - Management reported positive progress with the Love Made Fresh launch, focusing on improving on-shelf availability and marketing execution [28][30] Question: What are the challenges in the snacks segment? - Management identified challenges primarily with the hot snacks category, particularly with Totino's, while noting strong performance in salty snacks [62][63]

Financial Data and Key Metrics Changes - The company reaffirmed its guidance for fiscal 2026, indicating a significant step-up in financial performance expected in Q4 [3][4] - The company has seen improvements in household penetration, baseline volume, distribution, and market shares, which are critical for sustainable growth [4][6] - The company expects meaningful improvements in both top line and bottom line performance in Q4 and beyond [5][6] Business Line Data and Key Metrics Changes - In North America Retail, investments in brand remarkability are resonating with consumers, leading to improved household penetration and baseline growth [4][6] - The Pet segment is also experiencing growth, particularly in the cat feeding portfolio, with efforts to accelerate growth through the Love Made Fresh initiative [4][6] - The company is maintaining competitiveness in North America Foodservice and International markets, although challenges remain [4][6] Market Data and Key Metrics Changes - The company is focusing on enhancing margins and prioritizing resources on brands with the strongest growth potential, as evidenced by the decision to sell its Brazil business [5][6] - The international segment will concentrate on key global platforms, including super premium ice cream and pet food, which have better growth prospects [5][6] Company Strategy and Development Direction - The company is committed to improving organic sales results while maintaining industry-leading margins and efficiency through transformation initiatives [6][7] - The strategy includes a focus on innovation and renovation of core products, particularly in North America Retail and Pet segments [7][8] - The company aims to improve dollar share performance in North America Retail as pricing investments stabilize [7][8] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that while there is still work to be done, the current strategy is yielding positive results and confidence in future performance is high [4][6] - The company anticipates stable to growing volume as a key enabler for restoring margins, with expectations for improved price mix and productivity from transformation initiatives [39][44] - Management noted that consumer stress levels are higher than pre-COVID, impacting promotional activity and pricing dynamics [35][36] Other Important Information - The company has successfully achieved its goal of over 5,000 coolers for the Love Made Fresh product line and is focusing on improving on-shelf availability and product turns [27][29] - The company is experiencing a high single-digit decline in the snacks segment, primarily driven by challenges in the hot snacks category, particularly with the Totino's brand [60][62] Q&A Session Summary Question: Expectations for volume growth in fiscal 2027 - Management aims to increase competitiveness in dollar terms in fiscal 2027, with a focus on innovation and improved marketing [12] Question: Competitive landscape and pricing dynamics - The company has seen positive price mix trends and expects to close price gaps with competitors, particularly in the Pillsbury and cereal categories [18] Question: Performance of new products - New product innovation is tracking at about 25% growth in North America Retail, with strong consumer response to recent launches [22][24] Question: Food service segment performance - The food service segment has seen volume declines, particularly in bakery flour, but management remains confident in overall competitiveness [53][55] Question: Inflation and cost pressures - Management anticipates inflation pressures to remain in line with the current year, with labor being a significant component of cost structure [43][44] Question: Retailer inventory adjustments - The company has seen fluctuations in retailer inventories, particularly in the Pet segment, but expects a neutral impact in Q4 [69][70]

Financial Data and Key Metrics Changes - Backlog reached a record $19.9 million, an increase of $12.4 million and 165% year-over-year [10] - Pipeline expanded to $163.9 million, up $74.7 million and 84% year-over-year [10] - Revenue for Q3 2026 was $0.5 million, down from $0.8 million in Q3 2025; revenue for the nine months ended January 31, 2026, was $2.1 million, down from $4.5 million in the same period last year [11] - Gross profit for Q3 2026 was a loss of $0.8 million, compared to a gross profit of $0.2 million in Q3 2025 [12] - Net losses for Q3 2026 were $11.4 million, compared to $6.7 million in Q3 2025 [13][14] Business Line Data and Key Metrics Changes - Significant portion of the pipeline is associated with defense and security programs, indicating a strategic focus on these areas [4] - The company is advancing its integrated autonomous docking and charging solution, transitioning from prototype to full-scale build [5] - The operational data accumulated from real-world maritime environments is enhancing mission readiness and informing product improvements [7] Market Data and Key Metrics Changes - The company is expanding its global operational footprint, with shipments to Greece and ongoing customer operations in international defense and commercial markets [5] - Approximately half of the backlog is from North America, with the remainder split between Latin America and parts of the Middle East [20] Company Strategy and Development Direction - The company aims to enable autonomous systems to operate persistently offshore, supporting long-duration missions without traditional logistics [5] - The strategy focuses on building a global maritime autonomy infrastructure layer, positioning the company as a platform provider rather than just a product provider [8] - Continued engagement with government and commercial customers is expected to drive future growth [15] Management's Comments on Operating Environment and Future Outlook - Management noted strong demand signals across core markets, with backlog and pipeline levels significantly higher than a year ago [15] - The organization is aligned to support growth, focusing on execution, reliability, and delivering consistent solutions [16] Other Important Information - The company has a cash position of $7.2 million as of January 31, 2026, compared to $6.9 million at the beginning of the fiscal year [14] - Operating expenses increased due to higher non-cash stock-based compensation and increased headcount to strengthen competitive position [12][13] Q&A Session Summary Question: Visibility on backlog delivery cadence and categorization by geography or customer type - Management confirmed that a portion of the $19.9 million backlog is due for immediate delivery, with contracts for the Department of Homeland Security expected to start recognizing revenue soon [18][19] Question: Prospects for contracts in UAE waters - Management stated that assets are in the country and local staff are working on supporting shipping and safe port operations [22] Question: Inclusion of recurring revenues from Merrows in backlog - Management clarified that while there are no specific Merrows contracts, the Homeland Security contract utilizes the Merrows platform for data streaming [23][24] Question: Expectations for positive gross margins going forward - Management indicated that improvements in gross margins are expected as larger scale deployments are initiated [26] Question: Competition for potential orders and confidence in pipeline conversion - Management expressed confidence in the conversion of the $164 million pipeline to backlog, citing a well-positioned team and less competition in their market segment [27][28] Question: Status of defense engagements in Latin America - Management reported ongoing exercises in Latin America and discussions for deploying buoys for surveillance operations [33][34] Question: Inventory strategy and pre-build activity - Management confirmed that inventory growth reflects pre-building buoys to accelerate delivery and that this strategy will continue [35] Question: Expansion beyond Coast Guard into other DHS components - Management highlighted that their team’s clearance enables participation in discussions with various DHS components, positioning them for future opportunities [36]

Ovid Therapeutics (NasdaqGS:OVID) Q4 2025 Earnings call March 18, 2026 08:30 AM ET Company ParticipantsAlyssa Larios - Senior Associate in Equity ResearchJeffrey Rona - Chief Business and Financial OfficerMeg Alexander - President and CEOVictoria Fort - SVP of Corporate Affairs and Corporate StrategyConference Call ParticipantsFrançois Brisebois - Managing Director in Equity Research and Senior Biotechnology AnalystJay Olson - Managing Director in Equity Research and Senior Biotechnology AnalystLaura Chico ...

Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2025, was $22 million, a decrease of approximately 14% from $25.7 million in 2024 [17] - Gross profit increased to $8.4 million or 38.2% of revenue compared to $8.2 million or 32% of revenue in 2024 [19] - Operating expenses declined by 25% to $28.1 million in 2025 compared to $37.6 million in 2024 [20] - Net loss narrowed by 31% to $19.9 million in 2025 compared to $28.9 million in 2024 [22] Business Line Data and Key Metrics Changes - Revenue from ReWalk Personal Exoskeleton was relatively flat at $8.5 million in 2025 compared to $8.9 million in 2024, with units sold increasing by 22% year-over-year [17] - Revenue from MyoCycle FES bike declined by 50% to $600,000, reflecting a strategic focus on core products [18] - Revenue from AlterG products and services was $12.9 million, an 18% decline from 2024, primarily due to lower international sales [18] Market Data and Key Metrics Changes - Reimbursement coverage for ReWalk expanded to include three largest Medicare Advantage insurers in the U.S., covering over 16 million lives [13] - International distribution efforts accelerated following the receipt of CE mark, with Germany as the primary test market [13] Company Strategy and Development Direction - The company is executing a strategy to build a diversified biomedical innovation company with multiple technology platforms [3] - A strategic transaction with Oramed is expected to strengthen the financial foundation and expand strategic scope [4] - Focus on cash flow positive operations while investing in innovations that will define the future of the company [3][25] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about growth in the core med tech business and improvements in operating expenses [15] - The company is focused on building a strong payer engagement capability to expand patient access and accelerate adoption of technologies [11] Other Important Information - The company plans to increase investment in R&D as new products advance to market, including the upper body exoskeleton [21] - A $3 million loan agreement with Oramed was entered into for additional capital support [23] Q&A Session Questions and Answers Question: How does the Oramed POD technology align with the company's current infrastructure? - Management indicated that the integration of Oramed's technology would drive synergies across med tech and biotech, enhancing the company's decentralized approach to commercialization [27][28] Question: What is the timeline for the upper extremity robotic assistance product? - Management stated that the product could be a 510(k) exempt product, with a timeline of 18-24 months for commercialization [32][33] Question: How should investors view the company's diversification into biotech? - Management emphasized that a diversified portfolio in med tech and biotech is beneficial, providing multiple opportunities for product commercialization [42][43]

Financial Data and Key Metrics Changes - The company achieved an annual recurring revenue (ARR) of $1.125 billion, representing a 28% year-over-year growth, which is consistent with the growth rate maintained over the past three quarters [20][25] - SaaS ARR reached $746 million, reflecting a 38% year-over-year increase and accounting for 90% of net new ARR in fiscal Q4 [21][25] - The adjusted operating margin for Q4 was 20.6%, an expansion of 160 basis points year-over-year, while the annual adjusted operating margin was 18.1%, an increase of 270 basis points [25][27] Business Line Data and Key Metrics Changes - Net new ARR from emerging products more than doubled quarter-over-quarter, contributing approximately 17% of net new ARR in fiscal Q4 [22] - The average ARR per SaaS customer grew to over $380,000, a 19% increase from the previous year [22] - The company closed the fiscal year with 215 customers exceeding $1 million in ARR, a 34% increase from the previous year [23] Market Data and Key Metrics Changes - Non-human identities accounted for approximately 25% of SaaS identity growth in Q4 and now represent 11% of SaaS identities under governance [14] - The company noted a significant opportunity for growth as existing perpetual and term license customers represent approximately $350 million in ARR, with a typical 2-3x uplift upon migration [24] Company Strategy and Development Direction - The company aims to deepen its footprint within existing customers while attracting new customers, leveraging its SaaS-first strategy and AI-powered platform [16][17] - The focus is on defining a new standard of adaptive identity governance, emphasizing real-time governance and least privilege access [17][18] - The company is positioned as a foundational security control plane for the modern AI-powered enterprise, capitalizing on the growing demand for identity security solutions [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the evolving market landscape, particularly with the rise of AI and non-human identities [10][46] - The company anticipates FY 27 to be the year of AI adoption, with a strong pipeline and healthy demand for its identity security platform [16][20] - Management emphasized the importance of domain knowledge and the ability to leverage AI technologies to enhance customer security and operational efficiency [81] Other Important Information - The company generated $64 million in cash from operating activities and $57 million in free cash flow, representing a 19.5% free cash flow margin [25] - The guidance for FY 2027 includes an expected ARR of $1.361 billion, up 21% year-over-year, and revenue of approximately $1.265 billion, an 18% increase year-over-year [27] Q&A Session Summary Question: ARR guidance for fiscal 2027 - Management indicated strong momentum heading into the year, with a focus on prudent guidance despite healthy demand and a strong pipeline [31][32] Question: Impact of new pricing models on customer engagement - Management noted that new pricing models have shown significant uptake, contributing to strong migration and customer engagement [39] Question: Market expansion drivers and future growth - Management highlighted the significant market expansion driven by the rise of non-human identities and the need for adaptive identity security solutions [45][46] Question: Changes in sales cycles due to non-human identities - Management acknowledged that sales cycles have elongated slightly but did not see any recent changes that would alter this trend [94]

Financial Data and Key Metrics Changes - As of December 31, 2025, Ovid Therapeutics reported $90.4 million in cash equivalents and marketable securities [42] - The company announced a PIPE financing with gross proceeds totaling $60 million, which is expected to extend the cash runway into the second half of 2028 [42] - If the Series A warrants are fully exercised, the pro forma cash runway could extend well into 2029 [42] Business Line Data and Key Metrics Changes - The company received regulatory clearance for OV4071, the first-ever oral KCC2 direct activator, a quarter earlier than expected [5] - OV329, a next-generation GABA aminotransferase inhibitor, has shown no serious adverse events at the 7-milligram dose, indicating a strong safety and tolerability profile [5][13] - The company is launching additional studies for OV329 in infantile spasms and seizures associated with tuberous sclerosis complex, supported by new capital [7][8] Market Data and Key Metrics Changes - The market opportunity for OV329 is significant, especially in treating conditions like infantile spasms and tuberous sclerosis complex, where current treatment options are limited [24][27] - The peak sales of Sabril (Vigabatrin) reached over $320 million, indicating a substantial market potential for a safer alternative like OV329 [79] Company Strategy and Development Direction - Ovid Therapeutics aims to develop gentler, better medicines for the brain, focusing on controlling neural hyperexcitability through small molecule programs [9] - The company plans to initiate a phase 1 study for OV4071 and a ketamine challenge study to demonstrate proof of mechanism [33][40] - The strategy includes developing differentiated formulations for adult and pediatric populations, allowing for differential pricing based on the specific needs of each community [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of OV329 to be used earlier and longer in treatment, which could change the trajectory of diseases for children with severe conditions [78] - The company is optimistic about the upcoming milestones and catalysts, indicating a busy couple of years ahead [37] Other Important Information - Ovid Therapeutics does not plan to host regular quarterly earnings calls moving forward, indicating a shift in communication strategy [4] - The company is preparing for a KCC2 day to provide more insights into the KCC2 portfolio and its therapeutic potential [36] Q&A Session Summary Question: Can you provide more detail on OV329 and the visual monitoring? - Management confirmed that optic and retinal monitoring will continue through phase 2 and pivotal studies to ensure robust safety data [50] Question: What are the key endpoints for the planned phase two design for OV329? - The phase 2 study will target adults with treatment-resistant focal onset seizures, focusing on traditional endpoints like percent reduction in seizures and CGI endpoints [59] Question: What type of patients will be enrolled in the open-label photosensitive epilepsy study? - The study will enroll adults with diagnosed epilepsy and documented photosensitivity, using intermittent photic stimulation for screening [67] Question: How does the company plan to address long-term clinical development for OV329? - Management indicated that OV329 has broad therapeutic utility and that evidence will inform potential expansions into other indications [91]

Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $3.1 million, a 62% increase from $1.9 million in Q4 2024, driven by the U.S. launch of CGuard Prime and increased international market penetration [10] - U.S. revenue for Q4 was $866,000, representing a 74% sequential growth compared to Q3 2025 [10] - International revenue for Q4 was $2.3 million, reflecting a 17% growth compared to $1.9 million in Q4 2024 [10] - Gross profit for Q4 2025 was $1.2 million, or 37.5% of revenue, up from $469,000 or 24.1% of revenue in Q4 2024, primarily due to a favorable shift in revenue mix towards U.S. sales [11] - Net loss for Q4 2025 was $11.8 million, or $0.14 per share, compared to a net loss of $9.2 million or $0.19 per share in Q4 2024 [13] Business Line Data and Key Metrics Changes - The company has completed over 500 cases and gained approvals in prominent Integrated Delivery Networks (IDNs) in the U.S. [6] - The CGuard stent has been used in over 70,000 cases across 30 international markets, providing valuable real-world experience for the U.S. launch [6] Market Data and Key Metrics Changes - The company anticipates revenue for the full year 2026 to be in the range of $13 million to $15 million, reflecting a growth of approximately 45% to 65% over 2025 [15] - The company expects increasing sequential revenue growth in the second half of 2026, driven by anticipated FDA label expansion for CGuard Prime in TCAR procedures [16] Company Strategy and Development Direction - The company aims to achieve market leadership through a stent-first strategy, focusing on operational expansion and establishing U.S.-based production to meet growing demand [4][5] - The company is committed to continuous improvement of its products and plans to introduce enhancements to the delivery system in Q4 2026 [7][25] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the company's impact on stroke prevention and the future of endovascular care, emphasizing the importance of operational and commercial excellence [4] - The management highlighted the positive trajectory of the U.S. launch and the anticipated progress in 2026 [10][15] Other Important Information - Cash and cash equivalents and marketable securities were $54.2 million as of December 31, 2025, compared to $34.6 million at the end of the previous year [14] - The company has two remaining milestone-based tranches from a private placement, each providing gross proceeds of $17.9 million if fully exercised [14] Q&A Session Summary Question: Guidance for FY 2026 - The management expects moderate growth in OUS sales and sustained controlled launch in the U.S. for the first half, with acceleration in the second half due to anticipated TCAR indication and enhanced clinical performance [19][20] Question: Account Standpoint in the U.S. - The company has completed cases in roughly 80 centers, with over 200 centers in the pipeline for VAC and evaluation stages [23] Question: Next Generation Delivery System - The next generation delivery system is targeted for Q4 2026, with minor regulatory changes expected to go through a 30-day FDA review [25][27] Question: Timing for CGUARDIANS II Data - The first reveal of CGUARDIANS II data is expected at the Charing Cross Symposium in April [30] Question: Account Adoption and Productivity Metrics - The company aims for CGuard to become the everyday stent for physicians, with a focus on increasing account adoption and productivity [34][35]

Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $3.1 million, a 62% increase from $1.9 million in Q4 2024, driven by the U.S. launch of CGuard Prime and increased international market penetration [10] - U.S. revenue for Q4 was $866,000, representing a 74% sequential growth compared to Q3 [10] - International revenue for Q4 was $2.3 million, reflecting a 17% growth compared to $1.9 million in Q4 2024 [10] - Gross profit for Q4 2025 was $1.2 million, or 37.5% of revenue, up from $469,000 or 24.1% of revenue in Q4 2024, primarily due to a favorable shift in revenue mix towards U.S. sales [11] - Net loss for Q4 2025 was $11.8 million, or $0.14 per share, compared to a net loss of $9.2 million or $0.19 per share in Q4 2024 [13] Business Line Data and Key Metrics Changes - The CGuard Prime stent platform has been launched in the U.S., with over 500 cases completed and approvals gained in prominent Integrated Delivery Networks (IDNs) [6] - The company has built a U.S. commercial team of over 30 people, focusing on operational expansion and increasing manufacturing capacity [5] Market Data and Key Metrics Changes - The company is focusing on expanding its market presence in the U.S. and international markets, with a strategy to dominate the carotid stenting space [4] - The anticipated FDA approval for TCAR indications is expected to boost market opportunities significantly [8] Company Strategy and Development Direction - The company aims to achieve market leadership through a stent-first strategy, focusing on operational excellence and customer support [4] - Plans include expanding the clinical pipeline and advancing indications for CGuard, with multiple programs and studies underway [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of U.S. sales and anticipates continued progress in 2026, with revenue expected to be between $13 million and $15 million, reflecting a growth of approximately 45%-65% over 2025 [15] - The company is committed to continuous improvement and exceeding customer expectations, with plans to introduce enhancements to the delivery system in Q4 2026 [26] Other Important Information - Cash and cash equivalents and marketable securities were $54.2 million as of December 31, 2025, compared to $34.6 million at the end of the previous year [14] - The company has two remaining milestone-based tranches from a private placement, each providing gross proceeds of $17.9 million if fully exercised [14] Q&A Session Summary Question: Guidance for FY 2026 - Management expects moderate growth in OUS sales and acceleration in U.S. growth in the second half of 2026 due to anticipated TCAR indication and enhanced clinical performance [19][20] Question: Account Standpoint in the U.S. - Cases have been performed in roughly 80 centers, with over 200 centers in the pipeline for VAC and evaluation stages [23] Question: Next Generation Delivery System - The next generation delivery system is targeted for Q4 2026, with minor regulatory changes expected to go through a 30-day FDA review [26] Question: Timing for CGUARDIANS II Data - CGUARDIANS II data will be first revealed at the Charing Cross Symposium in April, likely as an interim cut [30] Question: Account Adoption and Productivity Metrics - A growing number of physicians are using CGuard as their everyday stent, with an average of 15-20 cases per physician per year [35]