Financial Data and Key Metrics Changes - For the full year 2025, total revenue was approximately $61.7 million, an increase of 4.3% from $59.1 million in 2024 [25][26] - In Q4 2025, total revenue was $15.7 million, up 6.9% from $14.7 million in Q4 2024 [25] - Treatment segment revenue increased by approximately 29% year-over-year, while services segment revenue decreased due to lower project work [13][26] - Gross profit for Q4 2025 was $1.2 million, compared to $594,000 in Q4 2024, with significant improvements in the treatment segment [26] - The net loss for Q4 2025 was $5.7 million, compared to a net loss of $3.5 million in the prior year [28] Business Line Data and Key Metrics Changes - Treatment segment revenue for the year increased by $10.1 million, while services segment revenue dropped by $7.6 million [26] - Treatment backlog increased by approximately 51% year-over-year to about $1.9 million, indicating growing demand for specialized treatment capabilities [13] - International revenue increased by approximately 163% year-over-year to about $6.4 million, reflecting strong global demand for waste treatment services [14] Market Data and Key Metrics Changes - The anticipated waste streams from the DFLAW program are expected to grow by as much as 20% due to changes in process flow [9] - The Hanford remediation programs are expected to generate sustainable waste streams over time, creating consistent long-term treatment demand [12] Company Strategy and Development Direction - The company is focused on strengthening its operational foundation and positioning for growth tied to the Department of Energy's Hanford cleanup mission [5] - Significant investments have been made in personnel, infrastructure, and plant capabilities to support increased waste volumes [6] - The renewal of the permit for the Perma-Fix Northwest facility significantly expands processing capacity, tripling liquid processing capacity to approximately 1.2 million gallons annually [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Q2 2026, anticipating stronger activity levels and increased waste receipts [40] - The transition of the DFLAW system into its operational phase is expected to be a catalyst for increased activity at the Northwest facility [80] - Management highlighted the long-term opportunity presented by the Hanford tank contractor's RFP for grouting and off-site disposition of waste [21] Other Important Information - The company is advancing the development of its PFAS destruction technology, with a new system expected to increase capacity significantly [17][19] - The services segment experienced a decline due to project timing and procurement cycles, but there are opportunities tied to nuclear services and government remediation programs [20] Q&A Session Summary Question: Can you give us a better sense of Q2 performance? - Management expressed confidence in Q2 based on new contract awards and mobilization of projects that will generate waste [34][35] Question: Can you comment on the grouting plans for the Hanford Site? - Management explained the different components of the Hanford Site and the aggressive plans for grouting waste, with significant opportunities for the company [41][42] Question: What is the current status of PFAS treatment capacity? - The original unit is operational, treating waste streams while the second unit is being built, expected to increase capacity significantly [67][70]

Financial Data and Key Metrics Changes - In 2025, adjusted operating profit increased by 30% to $1.3 billion, with profit margin expanding to 8.6%, up from 7.2% in 2024 [9][24] - Fourth quarter adjusted net income from continuing operations was $329 million, contributing to a record full year net income of $1 billion [24][25] - Adjusted diluted EPS for the fourth quarter was $0.83 per share, up from $0.52 per share in 2024, and for the full year was $2.55 per share, representing a 36% increase from 2024 [25] Business Line Data and Key Metrics Changes - Packaged Meats segment delivered fiscal year 2025 adjusted operating profitability despite raw material input cost increases of $525 million, with sales of $8.8 billion, a 5.3% increase compared to fiscal 2024 [25][26] - Fresh Pork segment achieved $209 million in adjusted operating profit, with sales of $8.3 billion, a 6% increase year-over-year, driven by a 5.8% increase in average selling price [27] - Hog Production generated $176 million in adjusted operating profit, the highest since 2014, with sales of $3.4 billion, a 13% increase year-over-year [27][28] Market Data and Key Metrics Changes - The company produced 11.1 million hogs in 2025, down from 14.6 million in 2024, reflecting a strategic rightsizing [20] - The average market hog sales price increased by 8.9% year-over-year, despite a reduction in the number of hogs produced [28] Company Strategy and Development Direction - The company aims to increase packaged meats profit through mix improvement, volume growth, and innovation, focusing on higher-margin, value-added product categories [12][13] - A new state-of-the-art processing facility is planned in Sioux Falls, South Dakota, with an estimated investment of $1.3 billion over three years, expected to modernize manufacturing and unlock long-term cost benefits [11][34] - The acquisition of Nathan's Famous is anticipated to be immediately accretive and will secure a core national brand, creating growth and synergy opportunities [10][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued margin expansion driven by strategies such as innovation, improved asset utilization, and cost savings [32] - The outlook for 2026 anticipates total company sales to increase by low single digits, with segment adjusted operating profit for packaged meats expected in the range of $1.1 billion to $1.2 billion [33] - Potential headwinds include cautious consumer spending and geopolitical dynamics, particularly related to the conflict in Iran affecting fuel and raw material costs [31][32] Other Important Information - The company returned value to shareholders through dividend payments of $1 per share in 2025, with an anticipated increase to $1.25 per share in 2026 [10][30] - The company maintains a strong financial position with a net debt to adjusted EBITDA ratio of 0.3 times and liquidity of $3.8 billion [29] Q&A Session Summary Question: Packaged meats outlook and margin perspective - Analyst inquired about the packaged meats outlook and margin expansion in light of input cost inflation and consumer demand [36][38] - Management noted that low single-digit revenue growth includes one-time inventory sales and expects lower raw material costs but still elevated compared to historical norms [39][40] Question: Hog production guidance and industry perspective - Analyst asked about the hog production guidance and industry supply dynamics [45] - Management confirmed that guidance reflects current market conditions and improvements in genetics and feed management [46][48] Question: Fresh pork segment risks and opportunities - Analyst requested elaboration on fresh pork business risks and opportunities for 2026 [51] - Management highlighted the focus on value-added products and the importance of connecting fresh pork with the packaged meats portfolio [56][57] Question: Capacity expansion project in Sioux Falls - Analyst inquired about the capital expenditure needs for the Sioux Falls project [58] - Management clarified that significant spending will occur in 2027 and 2028, with groundbreaking expected in early 2027 [59] Question: Margin cadence in packaged meats - Analyst sought clarity on margin cadence in the packaged meats segment [62] - Management emphasized a focus on quality merchandising and consumer loyalty, with expectations of consistent profitability throughout the year [64][66]

Financial Data and Key Metrics Changes - In 2025, adjusted operating profit increased by 30% to $1.3 billion, with profit margin expanding to 8.6%, up from 7.2% in 2024 [9][24] - Fourth quarter adjusted net income from continuing operations was $329 million, contributing to a record full year net income of $1 billion [24][25] - Adjusted diluted EPS for the fourth quarter was $0.83 per share, up from $0.52 per share in 2024, and for the full year was $2.55 per share, representing a 36% increase from 2024 [25] Business Line Data and Key Metrics Changes - Packaged Meats segment achieved adjusted operating profitability despite $525 million in raw material cost increases, with sales of $8.8 billion, a 5.3% increase compared to fiscal 2024 [25][26] - Fresh Pork segment delivered $209 million in adjusted operating profit, with sales of $8.3 billion, a 6% increase year-over-year, driven by a 5.8% increase in average selling price [27] - Hog Production generated $176 million in adjusted operating profit, the highest since 2014, with sales of $3.4 billion, a 13% increase year-over-year [27][28] Market Data and Key Metrics Changes - The company produced 11.1 million hogs in 2025, down from 14.6 million in 2024, reflecting a strategic rightsizing [20] - The company anticipates a 2.5% increase in pork production in 2026, with potential headwinds from PRRS affecting supply [31][76] Company Strategy and Development Direction - The company aims to increase packaged meats profit through mix improvement, volume growth, and innovation, while also focusing on maximizing net realizable value in fresh pork [12][19] - A significant investment of up to $1.3 billion is planned for a new processing facility in Sioux Falls, South Dakota, expected to modernize operations and enhance efficiency [11][34] - The acquisition of Nathan's Famous is expected to be immediately accretive and will secure a core national brand, creating growth and synergy opportunities [10][81] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued margin expansion and profitability in 2026, driven by strong protein demand and disciplined cost management [12][31] - The company is monitoring geopolitical factors, particularly the conflict in Iran, which could impact fuel and raw material costs [32][68] - Management highlighted the importance of innovation and operational efficiencies in maintaining competitive advantage [22][23] Other Important Information - The company returned value to shareholders through dividend payments of $1 per share in 2025, with an anticipated increase to $1.25 per share in 2026 [10][30] - The company maintains a strong financial position with a net debt to adjusted EBITDA ratio of 0.3x and liquidity of $3.8 billion [29] Q&A Session Summary Question: Packaged meats outlook and margin perspective - The company expects low single-digit growth for packaged meats, with margin expansion anticipated despite input cost inflation [37][40] Question: Hog production guidance and industry perspective - Management indicated that the guidance for hog production reflects current supply conditions and improvements in genetics and feed management [45][48] Question: Fresh pork segment risks and opportunities - The fresh pork team is focusing on value-added products and leveraging the packaged meats brand to enhance profitability [55][56] Question: Sioux Falls capacity expansion project - Groundbreaking for the new facility is expected in early 2027, with significant capital expenditures anticipated during 2027 and 2028 [58][59]

Financial Data and Key Metrics Changes - In 2025, adjusted operating profit increased by 30% to $1.3 billion, with profit margin expanding to 8.6%, up from 7.2% in 2024 [8][24] - Total company sales increased by 10% for the year, with a 7% increase in the fourth quarter [23][28] - Adjusted net income for the full year reached $1 billion, with adjusted diluted EPS increasing by 36% to $2.55 per share [24][28] Business Line Data and Key Metrics Changes - Packaged Meats segment achieved sales of $8.8 billion, a 5.3% increase compared to 2024, despite raw material cost increases of $525 million [24][25] - Fresh Pork segment delivered $209 million in adjusted operating profit, with sales of $8.3 billion, a 6% year-over-year increase [26] - Hog Production generated $176 million in adjusted operating profit, the highest since 2014, with sales of $3.4 billion, reflecting a 13% increase year-over-year [26][27] Market Data and Key Metrics Changes - The company produced 11.1 million hogs in 2025, down from 14.6 million in 2024, as part of a rightsizing strategy [19] - The average market hog sales price increased by 8.9% year-over-year, despite a reduction in the number of hogs produced [27] Company Strategy and Development Direction - The company aims to grow packaged meats profit through mix improvement, volume growth, and innovation, focusing on higher-margin, value-added product categories [11][12] - A new state-of-the-art processing facility is planned for Sioux Falls, South Dakota, with an estimated investment of $1.3 billion over three years, expected to modernize manufacturing and unlock long-term efficiencies [10][33] - The acquisition of Nathan's Famous is anticipated to be immediately accretive and will secure a core national brand, creating growth and synergy opportunities [9][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued protein demand and the favorable positioning of pork as a healthy, affordable option for consumers [10][30] - The company expects continued margin expansion in 2026, driven by disciplined cost management and execution of core strategies [30][32] - Potential headwinds include cautious consumer spending and geopolitical factors affecting input costs [31] Other Important Information - The company returned value to shareholders through a $1 per share dividend in 2025 and anticipates an annual dividend of $1.25 in 2026 [9][29] - The net debt to adjusted EBITDA ratio was 0.3 times at the end of 2025, indicating a strong financial position [28] Q&A Session Summary Question: Packaged meats outlook and margin perspective - Management noted that low single-digit revenue growth includes one-time inventory sales and expects input costs to remain elevated but manageable [38][39] Question: Hog production guidance and industry perspective - Management indicated that supply expansion is limited, and they are comfortable with the guidance provided, reflecting structural improvements in their operations [44][46] Question: Fresh pork segment risks and opportunities - Management highlighted the focus on value-added products and the importance of connecting the fresh pork business with the packaged meats portfolio for improved results [50][54] Question: Capacity expansion project in Sioux Falls - Management confirmed that significant capital expenditures for the Sioux Falls project will occur in 2027 and 2028, with expected efficiency gains from the new facility [56][57] Question: Nathan's Famous acquisition benefits - Management stated that the acquisition will eliminate licensing fees and provide immediate earnings growth, with more details to be shared post-close [78][80]

Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and marketable securities totaled $36.4 million [25] - Total operating expenses for Q4 2025 were $14.7 million, and for the full year, they were $54.9 million, reflecting ongoing investments in regulatory, clinical, and commercial activities [25] - The total net loss for Q4 2025 was $14.7 million, and for the full year, it was $54.7 million [25] Business Line Data and Key Metrics Changes - Achieve Life Sciences is transitioning from a clinical development company to a commercially focused enterprise, with a primary objective to make cytisinicline available to 25 million smokers and nearly 18 million vapers [5][6] - The NDA submission for smoking cessation was accepted by the FDA, marking a significant step towards becoming the first new FDA-approved treatment in 20 years [6][7] - The ORCA-OL long-term exposure trial demonstrated cytisinicline's safety profile, showing strong tolerability and excellent patient satisfaction [8] Market Data and Key Metrics Changes - Approximately 25 million adults in the U.S. smoke cigarettes, with over 15 million attempting to quit each year [12] - The CDC estimates that smoking causes around 500,000 deaths annually and incurs over $600 billion in healthcare costs and lost productivity [12] - There are 6 million COPD smokers in the U.S. with limited options for cessation, highlighting the potential market for cytisinicline [8] Company Strategy and Development Direction - The company aims to launch cytisinicline for smoking cessation in the first half of 2027, focusing on ensuring supply chain readiness and building a scalable commercial model [9][10][19] - Achieve is leveraging AI and advanced analytics to enhance decision-making and customer engagement, positioning itself for an efficient launch [10][23] - The company has initiated a "Willpower" awareness campaign to reframe the conversation around nicotine dependence as a medical condition [14][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory progress and the potential for cytisinicline to deliver the first FDA-approved treatment for nicotine dependence in two decades [18] - The company is focused on addressing the unmet medical needs in nicotine dependence, emphasizing the importance of a controlled and successful product launch [26][27] - Management highlighted the urgency of the public health need for vaping cessation treatments, with the potential to be first to market [27] Other Important Information - Achieve has partnered with Adare Pharma Solutions for U.S. manufacturing, which is expected to enhance supply chain security and reduce risks associated with international imports [10][11] - The company is actively engaging with payers to secure coverage and affordability for cytisinicline, with ongoing discussions showing positive feedback [21][53] Q&A Session Summary Question: What is the critical path between NDA approval and launch? - The company needs to ensure drug availability in the supply chain and is working on additional data and partnerships during the lead-up to launch [30][31] Question: Will the manufacturer in the NDA supply commercial product? - The company plans to transfer manufacturing to Adare, ensuring contingency supply and addressing observations from the FDA inspection [36][37] Question: What is the current awareness level among healthcare providers? - Awareness has not been a priority pre-approval, but the company plans to ramp up educational efforts as the launch approaches [40][42] Question: What is the status of FDA dialogue on the vaping indication? - Discussions with the FDA have focused on protocol approval, with site selection for the ORCA-V2 trial already underway [44][45] Question: How robust is the raw plant material supply chain? - The company has stockpiled sufficient starting material for over three years of supply, ensuring readiness for market demand [58] Question: What are the pricing considerations for cytisinicline? - The company is not ready to comment on pricing but acknowledges the substantial unmet need highlighted in the ICER report [66][68]

Financial Data and Key Metrics Changes - The company ended Q4 2025 with approximately $292.3 million in cash and marketable securities, remaining debt-free with about 31.3 million shares outstanding [32] - Q4 net product revenues were approximately $1.6 million, with over 20,000 monthly paid and filled prescriptions [32] - Total Q4 operating expenses were approximately $40 million, with a net cash burn of about $32 million [33][34] - The net loss per share for Q4 was $1.16, compared to a net loss per share of $0.46 in Q4 2024 [35] Business Line Data and Key Metrics Changes - The company sold over 45,000 boxes of LNZ100, prescribed by more than 10,000 eye care professionals [7] - The product is showing strong refill behavior, with patients moving from one-month to three-month prescriptions [47] - The top 1,000 prescribers are filling over 40% more scripts per doctor compared to a comparable point in the VUITY launch [8][22] Market Data and Key Metrics Changes - Presbyopia affects approximately 128 million people in the United States, representing a significant market opportunity [6][18] - The company is seeing a broad base of prescribing physicians, with over 55% of ECPs having written VIZZ multiple times [20] Company Strategy and Development Direction - The company aims to build a new treatment category for presbyopia, focusing on accelerating adoption through disciplined execution and investment [16][40] - The sales force is expanding from 88 to 117 representatives to increase call frequency and coverage of eye care professionals [12][23] - The direct-to-consumer campaign is designed to build consumer awareness and drive demand for VIZZ [14][26] Management's Comments on Operating Environment and Future Outlook - Management is optimistic about the early signals of patient persistence and the growing base of prescribing physicians [40] - The company expects to see an acceleration in new patient starts as prescriber habits build and consumer awareness grows [16][40] - The operational actions taken in the field are aimed at enhancing adoption and integrating VIZZ into everyday clinical practice [12][16] Other Important Information - The company has submitted multiple NDA applications for international approvals, anticipating potential approvals in early 2027 [39] - The direct-to-consumer campaign has resulted in a significant increase in website traffic, with spikes of up to 10 times normal levels during national activations [14][26] Q&A Session Summary Question: Can you discuss the sampling dynamic to NRX and retention? - Management feels confident about the adoption, noting strong early signals of refill behavior and patient commitment to the product [45][47] Question: What investments are being made to broaden patient demand? - The focus is on digital advertising and optimizing media placements to effectively reach target demographics [49][50] Question: What percentage of prescribers are from the initial target group versus inbounds from patient demand? - The company is seeing growth in prescribers from both target and non-target groups, with many new prescribers who had not previously written for VUITY now engaging with VIZZ [52][53] Question: Can you elaborate on the behavior of the top prescribers? - The top prescribers are effectively integrating VIZZ into their practices and are more comfortable with new technologies, leading to higher prescription rates [59][62]

Financial Data and Key Metrics Changes - The company reported record net product sales of $44.6 million for the full year 2025, a 50% increase from $29.6 million in 2024 [5][20] - For Q4 2025, net product sales were $13.8 million, up approximately 75% from $7.9 million in Q4 2024 [19][20] - Selling and marketing expenses for Q4 2025 were $6.1 million, compared to $3.9 million in Q4 2024, reflecting increased payroll and marketing efforts [20][21] - General and administrative expenses for Q4 2025 were $8.9 million, up from $4.2 million in Q4 2024 [21][22] - Cash and cash equivalents stood at $36.8 million as of December 31, 2025, bolstered by $42 million in net proceeds from equity offerings [22][23] Business Line Data and Key Metrics Changes - The Fennec HEARS patient support program achieved record performance in Q4, with significant increases in patient enrollments, prescribed and infused vials, and conversion rates, which rose to 70% in Q4 from 50% in Q1 [8][19] - The company expanded its capabilities to target the adolescent and young adult (AYA) market, enhancing its customer-facing team to increase reach and frequency [6][7] Market Data and Key Metrics Changes - The company is focusing on expanding awareness and use of PEDMARK, particularly among young adult testicular cancer patients, with initiatives planned around events like the Indy 500 and significant presence at the ASCO meeting [9][10] - The company is also advancing its clinical evidence strategy, with ongoing studies in Japan and partnerships with leading academic institutions to generate new clinical data [10][12] Company Strategy and Development Direction - The company aims for global expansion and sustained growth, with a focus on executing its strategic plans and enhancing its operating leverage [11] - The management emphasized a balanced approach to capital allocation, investing in high-impact initiatives while maintaining financial rigor [7][11] - The company is committed to establishing PEDMARK as the standard of care for patients receiving cisplatin, with a focus on expanding clinical evidence and guideline recognition [15][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to execute its plans and achieve long-term value creation, highlighting a strong foundation built in 2025 [11][12] - The management noted that the company anticipates generating positive cash flow in Q1 2026, with early collection of receivables benefiting cash position [23] - The settlement of patent litigation regarding PEDMARK is expected to provide market exclusivity and save on annual G&A expenses, allowing for reinvestment in commercial expansion [23][24] Other Important Information - The company has zero debt outstanding, marking the strongest balance sheet in its history [22][23] - The management is focused on expanding the clinical evidence base for PEDMARK, particularly in the AYA population, and is in ongoing dialogue with regulatory authorities regarding potential label expansions [29][30] Q&A Session Summary Question: What is the biggest challenge or pushback from physicians regarding PEDMARK? - The primary concern has been whether sodium thiosulfate could reduce cisplatin's anti-tumor activity. Long-term follow-up studies have shown no difference in overall survival between the PEDMARK plus cisplatin arm and the cisplatin alone arm, which has helped shift physician confidence [25][26][27] Question: What is Fennec's regulatory strategy for the AYA population? - The company is focused on expanding the clinical evidence base and maintaining dialogue with regulatory authorities regarding potential pathways for label expansion as data matures [29][30] Question: Can you provide an estimate on cash operating expenses for 2026? - Cash operating expenses are anticipated to grow from approximately $35 million in 2025 to about $50 million in 2026, driven by commercial and medical expansions [31][33] Question: Can you provide an update on the Norgine partnership and ex-U.S. progress? - Norgine is planning 8-10 launches in 2026, with initial revenue contributions expected in the second half of 2026 [34][35] Question: When will you provide revenue or EBITDA guidance in 2026? - The company intends to evaluate the potential for issuing revenue and EBITDA guidance as it monitors the impact of growth initiatives throughout the year [36] Question: Can you elaborate on the recent field force expansion? - The expansion is targeted at building territory managers to increase reach and frequency, focusing on high-tier accounts and supporting activation of new centers [37][38] Question: How is the Fennec HEARS program impacting commercial demand? - The program primarily addresses access barriers, ensuring appropriate patients can start and complete therapy, which supports clinical adoption and physician decision-making [39][40]

Financial Data and Key Metrics Changes - The company reported record net product sales of $44.6 million for the full year 2025, a 50% increase from $29.6 million in 2024 [5][20] - For Q4 2025, net product sales were $13.8 million, up approximately 75% from $7.9 million in Q4 2024 [19][20] - Selling and marketing expenses for Q4 2025 were $6.1 million, compared to $3.9 million in Q4 2024, reflecting increased payroll and marketing efforts [20][21] - General and administrative expenses for Q4 2025 were $8.9 million, up from $4.2 million in Q4 2024 [21][22] - Cash and cash equivalents stood at $36.8 million as of December 31, 2025, bolstered by $42 million in net proceeds from equity offerings [22][23] Business Line Data and Key Metrics Changes - The Fennec HEARS patient support program achieved record performance in Q4, with significant increases in patient enrollments, prescribed and infused vials, and conversion rates, which rose to 70% in Q4 from 50% in Q1 [8][19] - The company expanded its capabilities to target the adolescent and young adult (AYA) market, enhancing its customer-facing team to increase reach and frequency [6][7] Market Data and Key Metrics Changes - The company is focusing on expanding awareness and use of PEDMARK, particularly among young adult testicular cancer patients, with initiatives planned around major events like the Indy 500 and the ASCO meeting [9][10] - The company is also making strides in Japan with the STS-J01 clinical trial for PEDMARK, which is crucial for global expansion [10] Company Strategy and Development Direction - The company aims for global expansion and sustained growth, with a focus on execution and enhancing its medical and commercial strategies [11] - The strategic plan includes increasing clinical evidence generation and strengthening relationships with key opinion leaders and academic institutions [12][15] - The company is committed to addressing unmet needs in vulnerable groups, such as AYA and adult patients, through evidence-based initiatives [15][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to execute its plans and achieve long-term value creation, citing a strong balance sheet and disciplined capital allocation [7][22] - The management team highlighted the importance of ongoing engagement with healthcare providers to enhance the adoption of PEDMARK and address concerns regarding its use alongside cisplatin [25][28] Other Important Information - The company announced the settlement of patent litigation regarding PEDMARK, which will provide market exclusivity until September 1, 2033, saving millions in annual G&A expenses [23][24] - The company anticipates generating positive cash flow in Q1 2026, aided by early collection of receivables [23] Q&A Session Summary Question: What is the biggest challenge or pushback from physicians regarding PEDMARK? - The primary concern has been whether sodium thiosulfate interferes with cisplatin's anti-tumor activity. Long-term follow-up data shows no difference in survival outcomes, which has helped shift physician confidence [25][26][27] Question: What is Fennec's regulatory strategy for the AYA population? - The company is focused on expanding clinical evidence and maintaining dialogue with regulatory authorities for potential label expansion as data matures [29][30] Question: Can you provide an estimate on cash operating expenses for 2026? - Cash operating expenses are expected to grow from approximately $35 million in 2025 to about $50 million in 2026, driven by commercial and medical expansions [31][33] Question: Can you provide an update on the Norgine partnership and ex-U.S. progress? - Norgine plans 8-10 launches in 2026, with initial revenue contributions expected in the second half of 2026 [34][35] Question: When do you expect to see initial revenue from the Norgine partnership? - Revenue contributions from Norgine are anticipated to materialize in the second half of 2026, particularly after pricing is established in Germany [60] Question: How is the company addressing the growth of treated patients in Q4? - The company is seeing significant growth in AYA patients, with a focus on both existing and new accounts, and expects this trend to continue [51][52][55]

Financial Data and Key Metrics Changes - For the full fiscal year 2025, the company recorded net product sales of $44.6 million, compared to $29.6 million in 2024, representing an increase of approximately 50% [6][21] - In the fourth quarter of 2025, net product sales were $13.8 million, compared to $7.9 million in the comparable period in 2024, representing an increase of approximately 75% [20][21] - The company achieved a record performance in patient support program Fennec HEARS, with conversion rates up 70% in Q4 compared to 50% in the first quarter [9] Business Line Data and Key Metrics Changes - The growth in net product sales is attributed to both new and existing accounts, with notable success in conversion and adherence of PEDMARK patients [21] - Selling and marketing expenses for Q4 2025 were $6.1 million, compared to $3.9 million in Q4 2024, largely due to increased payroll and marketing expenses [21][22] - General and administrative expenses for Q4 2025 were $8.9 million, compared to $4.2 million in Q4 2024, driven by higher legal expenses and increased payroll [22][23] Market Data and Key Metrics Changes - The company expanded its capabilities to include new territories and high-prescribing targets in the adolescent and young adult (AYA) market [8] - The AYA market represents a significant opportunity, with an addressable market of over 20,000 patients annually [36] Company Strategy and Development Direction - The company aims to enhance execution by increasing its customer-facing team and expanding its reach to help more cancer patients protect their hearing [7][8] - A focused strategy was outlined to expand and deepen clinical evidence supporting products via institution-led initiatives, targeting additional tumor types and patient populations [16][31] - The company plans to continue investing in growth while maintaining financial rigor, positioning itself for long-term value creation [8][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to execute plans and achieve sustained growth, emphasizing the importance of expanding awareness of cisplatin-induced ototoxicity [12][78] - The company anticipates generating positive cash flow in Q1 2026, with a strong balance sheet and zero debt outstanding [23][24] - Management highlighted the importance of ongoing dialogue with regulatory authorities regarding potential pathways for label expansion as clinical data matures [30][31] Other Important Information - The company announced the settlement of patent litigation regarding PEDMARK in the U.S., which will save millions in annual G&A and provide market exclusivity until September 1, 2033 [24][25] - The company is focused on expanding its commercial team and enhancing its operational infrastructure to ensure efficient access for patients [9][12] Q&A Session Summary Question: What is the biggest challenge or pushback from physicians regarding PEDMARK? - Management noted that the primary concern has been whether sodium thiosulfate could reduce cisplatin's anti-tumor activity, but long-term follow-up studies have shown no difference in overall survival [26][27] Question: What is Fennec's regulatory strategy for the AYA population? - The company is focused on expanding the clinical evidence base and maintaining dialogue with regulatory authorities regarding potential pathways for label expansion [30][31] Question: Can you provide an estimate on cash operating expenses for 2026? - The company anticipates cash operating expenses to grow from approximately $35 million in 2025 to approximately $50 million in 2026, focusing on commercial and medical expansions [32] Question: When would you expect to see initial revenue from the Norgine partnership? - Initial revenue contributions from Norgine are anticipated in the second half of 2026, following pricing approvals in Germany [57] Question: How is the company thinking about business development going forward? - The company sees significant opportunities in expanding PEDMARK's reach and is open to evaluating potential late-stage assets or commercial assets as it continues to grow [71]

Financial Data and Key Metrics Changes - For fiscal 2025, the company generated net sales of $7.65 billion, adjusted EBITDA of $931 million, and adjusted diluted EPS of $2.97, reflecting a 3% increase in net sales compared to the previous year [9][35] - Adjusted EBITDA margin declined by 30 basis points to 12.2%, while gross margin increased by 30 basis points to 26.9% due to higher private label penetration and disciplined purchasing [36][37] - Operating cash flow for the year was $650 million, representing a conversion rate of approximately 70% from adjusted EBITDA [38] Business Line Data and Key Metrics Changes - Municipal projects accounted for 44% of sales, with low- to mid-single-digit growth, while non-residential sales were relatively flat, and residential lot development declined low double digits [5][10] - The company achieved 3 points of organic above-market growth, driven by sales initiatives and geographic expansion, including the opening of 10 new branches [13][14] - The smart metering business grew at an average annual rate of approximately 14% over the past five years, with significant contributions from large contracts [24][82] Market Data and Key Metrics Changes - The addressable market across the U.S. and Canada is estimated at $44 billion, up approximately $5 billion from the previous year, with the company holding about 20% market share in the U.S. [6][7] - The residential market is expected to remain challenged in the near term due to housing affordability and higher mortgage rates, but long-term demand drivers remain strong [11][18] Company Strategy and Development Direction - The company aims to extend its competitive advantages, compound market share gains, and expand structural earnings power [16][42] - Investments are being made in product offerings, capabilities, and geographic expansion to drive market share gains and support margin expansion [21][31] - The company is focused on disciplined M&A to complement organic growth, with a pipeline of over 50 opportunities evaluated annually [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the municipal market due to stable funding sources, while remaining cautious about the private construction market amid geopolitical volatility and interest rate uncertainties [40][41] - The company expects net sales for fiscal 2026 to be between $7.8 billion and $7.9 billion, with adjusted EBITDA of $950 million to $980 million [39] Other Important Information - The company returned $155 million to shareholders through share repurchases during the year, reducing the share count by approximately 3.2 million [38] - The company has a strong liquidity position with $1.45 billion available, including $220 million in cash [38] Q&A Session Summary Question: Growth disconnect of Core & Main versus competitors - Management acknowledged differences in market presence and product mix, noting strong share growth in smart meters and treatment plants, while recognizing competitors' advantages in certain markets [46][49] Question: Cost out program and its impact - Management confirmed that the $30 million cost out program was completed in FY 2025, with benefits expected to continue into FY 2026 [52] Question: Current market conditions and commodity inflation - Management is monitoring the impact of geopolitical events on fuel and resin prices, indicating potential price increases in certain product categories [56][58] Question: Growth investments in data centers and treatment plants - The company plans to invest in additional resources for treatment plant initiatives, enhancing capabilities for larger projects [64] Question: EBITDA guidance and its components - Management provided insights on the guidance range, emphasizing the importance of pricing stability and potential inflation impacts on margins [70][73] Question: M&A strategy and expectations - Management expressed confidence in the M&A pipeline, anticipating a return to a more normalized cadence of acquisitions in the coming years [76] Question: Growth expectations for the meters business - The meters business is expected to continue delivering low double-digit growth, supported by a strong pipeline of large projects [82]