Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and marketable securities totaled $36.4 million, with total operating expenses for Q4 2025 at $14.7 million and for the full year at $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 was $54.7 million, indicating a consistent investment strategy despite losses [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 in the U.S. [5][6] - The NDA submission for smoking cessation was accepted by the FDA, marking a significant milestone towards becoming the first new FDA-approved treatment in 20 years [6][7] Market Data and Key Metrics Changes - The company highlighted the urgent public health need for nicotine dependence treatment, with approximately 25 million adults in the U.S. smoking and over 15 million attempting to quit annually [12] - The recognition of cytisinicline as a national priority by the FDA enhances its market potential, particularly for vaping cessation, where no approved treatments currently exist [6][18] Company Strategy and Development Direction - Achieve is building a scalable, data-driven commercial model to launch cytisinicline, utilizing an omni-channel digital platform for precision targeting of physicians and patients [9][10] - The partnership with Adare Pharma Solutions aims to secure the supply chain and reduce risks associated with international pharmaceutical importation, enhancing operational readiness for the planned commercial launch in the first half of 2027 [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory progress and the potential of cytisinicline to deliver the first FDA-approved treatment for nicotine dependence in two decades, emphasizing the importance of addressing the unmet medical needs in this area [26][27] - The company is focused on ensuring a controlled and successful launch, with ongoing discussions with payers to secure coverage and affordability for cytisinicline [19][53] Other Important Information - The ORCA-OL long-term exposure trial demonstrated cytisinicline's safety profile and strong tolerability, with high patient satisfaction reported [8][17] - The company is leveraging advanced analytics and machine learning to enhance decision-making and customer engagement, positioning itself for an efficient launch [9][23] Q&A Session Summary Question: Can you talk about the critical path between a late June NDA approval and a first half launch? - The primary consideration is ensuring drug availability in the supply chain, with all trade and distribution processes ready to go once the drug is available [30][31] Question: Did you imply that the manufacturer in the NDA will not be supplying commercial product, rather Adare will? - The PDUFA date remains June 20, and the decision to transfer manufacturing to the U.S. was made to ensure contingency supply and address geopolitical concerns [36][37] Question: Can you discuss the current awareness level with healthcare providers and plans for 2026? - Awareness has not been a priority yet, but as the launch approaches, the company plans to ramp up educational efforts specific to cytisinicline [40][42] Question: What is the status of the raw plant material supply chain? - The company has been stockpiling starting material and expects to have more than three years' supply by the time of launch [58] Question: Can you comment on the cytisinicline dosing schedule and potential compliance issues? - High adherence rates were reported in trials, with participants finding the dosing schedule manageable and effective in addressing cravings [60][61] 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 - For Q4 2025, the company reported a GAAP net loss of $8.9 million, or $0.17 per share, compared to a net loss of $0.14 per share for the full year [4][15] - Distributable earnings for Q4 were approximately $0.00 per share, while for the full year, it was $0.14 per share [4] - The cumulative declared dividends for 2025 totaled $0.22 per common share, with a quarterly dividend of $0.04 declared for Q4 and Q1 2026 [4][15] - The total book equity at the end of Q4 was approximately $219 million, with a total book value of common stock at approximately $159 million, or $3.03 per share, down from $3.25 per share as of September 30 [18] Business Line Data and Key Metrics Changes - The company acquired or funded $400 million of loan assets during Q4, primarily related to the LMNT 2025-FL3 transaction [20] - The total loan portfolio consisted of 61 floating rate loans with an aggregate unpaid principal balance of approximately $1.1 billion, with a weighted average floating rate of 333 basis points over SOFR [20] - The weighted average risk rating improved to 3.2 from 3.6 quarter-over-quarter, with approximately 83% of loans rated 3 or better [21][22] Market Data and Key Metrics Changes - The U.S. economy remains resilient, though growth is moderating amid increased uncertainty due to monetary policy and geopolitical risks [5] - Capital market conditions in commercial real estate have improved, with increased liquidity, although transaction activity remains below historical averages [5][8] - Rent growth in multifamily markets is modest but showing early signs of re-acceleration in supply-constrained areas, while occupancy rates remain stable overall [6] Company Strategy and Development Direction - The company is focused on active asset management, resolving legacy positions, and maintaining a disciplined approach to capital deployment [13][14] - The strategy includes leveraging improved capital market conditions while being cautious and selective in deploying capital [14] - The company aims to navigate the current environment by focusing on strong credit fundamentals and risk-adjusted returns [14] Management's Comments on Operating Environment and Future Outlook - Management noted that while the recovery in commercial real estate credit markets is uneven, they remain encouraged by improving conditions [13] - The company expects a market characterized by selectivity, with outcomes differentiated by asset quality and capital structure [13] - Management emphasized the importance of evaluating sponsor strength and market expectations in the current volatile environment [28][29] Other Important Information - The company ended 2025 with an unrestricted cash balance of $23 million, and the LMNT 2025-FL3 CLO was fully deployed [18] - The company recorded an unrealized provision for credit losses of $8.6 million during Q4, increasing the specific allowance for credit losses to $17.6 million [17] Q&A Session Summary Question: Context on risk, reward, and opportunity for new capital deployment - Management acknowledged the current market environment presents challenges but remains confident in the multifamily market's strength [28][29] Question: Updated comfort zone for leverage with the new CLO closed - Management indicated that average leverage at the asset level has declined compared to historical norms, with few assets exceeding 80% [32][33] Question: Balance of non-accruals at year-end and their drag on earnings - Non-accruals at year-end amounted to $102 million, with a drag on earnings of about $0.02 [36] Question: Path to dividend coverage this year - Management stated that achieving dividend coverage will likely require both cleaning up the existing portfolio and portfolio growth [37][39] Question: Insights on Q1 2026 - Management highlighted a focus on asset management and resolving legacy assets, with expectations aligned with their plans [43][44]

Financial Data and Key Metrics Changes - The company reported revenue of approximately $2.5 billion, an increase of 1.9% on a constant currency basis and over 5% on a reported basis [8] - Non-GAAP operating income was $295 million, and adjusted EBITDA was $348 million, with a margin of 13.9% [9] - Non-GAAP diluted EPS was $2.61, in line with guidance [9] - Adjusted free cash flow was negative $145 million, reflecting an increase in accounts receivable [10] Business Line Data and Key Metrics Changes - Revenue from banking and financial services clients grew 13% year-over-year, while retail, travel, and e-commerce clients grew 6% [8] - Media and communications revenues grew 3%, primarily from clients outside the U.S. [8] - Technology and consumer electronics verticals decreased about 6%, driven by lighter volumes than expected [8] Market Data and Key Metrics Changes - The company noted a solid demand environment, with a significant increase in AI-related bookings, which more than doubled [5] - The pipeline of opportunities remains strong, indicating a shift towards a higher solution mix [5] Company Strategy and Development Direction - The company is focused on securing complex work and high-value services, leveraging proprietary AI technologies to differentiate in the market [6] - There is an emphasis on driving internal efficiencies to fuel continued investment in areas of new growth [6] - The company aims to reduce net leverage to below 2.6 times adjusted EBITDA by the end of fiscal 2026 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to drive year-over-year profitability growth in the second half of 2026 [16] - The geopolitical situation has had minimal impact on client behavior, with exposure to such risks being about 1% of revenue [51] - Management expects margin improvement in the second half of the year due to cost actions and increased revenue [25][27] Other Important Information - The company returned approximately $65 million to shareholders, including share repurchases and dividends [11] - The company issued $600 million of 3-year senior notes to refinance existing debt [12] Q&A Session Summary Question: Revenue related to AI and iX suite - Management indicated that the iX Hello solution is priced by consumption, leading to initial negative margins that turn positive as scale increases [19] - The iX Hero product operates on a subscription basis, with expectations to reach or exceed $100 million in annual recurring revenue by the end of the fiscal year [20] Question: Margin improvement cadence - Management expects margins to be somewhat compressed in the first half, with sequential expansion in the second half driven by cost actions and additional revenue [25][27] Question: Impact of offshore movement on revenues - Approximately 15% of revenue is delivered from North America and Western Europe, with a projected 2-point headwind from onshore movement [29] Question: Philosophy behind divestitures - The divestitures of two small non-strategic businesses were made as they were not growing or accretive to overall margins, with no imminent plans for further divestitures [35] Question: Stability of banking and retail growth - Management expects sustained growth in banking and retail, driven by complex work and new solutions being offered [44][46]

Financial Data and Key Metrics Changes - The company's top-line revenue increased by 46.7% to approximately RMB 5.94 billion [4][38] - Gross profit grew by 72.5% year-over-year to slightly below RMB 2.14 billion, with gross profit margin rising from 30.6% to 36% [39][40] - Adjusted net profit saw a growth rate of 69.9%, reaching around RMB 1.6 billion, with adjusted net profit margin increasing from 22.6% to 26.2% [39][40][45] - The backlog reached close to $1.5 billion, representing over 50% year-over-year growth [5][45] Business Line Data and Key Metrics Changes - The company signed a record 70 new ICMC projects and 10 new PBQ projects in 2025, with active CMC projects totaling 252 [4][11] - ADCs accounted for approximately 90% of overall revenue, while XDCs contributed around 7% [39] - The number of clients increased to over 640, including 14 of the top 20 pharmaceutical companies [15] Market Data and Key Metrics Changes - The company's market share expanded to over 24% by the end of 2025, up from 21.7% in 2024 [15] - Revenue from overseas clients, particularly in the U.S., accounted for 51% of total revenue, with North America and Europe collectively representing 85% [40][41] Company Strategy and Development Direction - The company is focusing on expanding its commercial manufacturing capabilities, particularly in linker-payloads, with significant investments planned for the Jiangyin site [30][34] - The acquisition of BioDlink is expected to enhance operational synergies and expand the client base [36][37] - The company aims to maintain a compound annual growth rate (CAGR) of 30%-35% over the next few years, driven by innovations in ADC and XDC modalities [54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining a growth rate of around 35% for 2026, despite potential margin dilution from the integration of BioDlink and ramp-up of the Singapore facility [60][62] - The company anticipates a significant increase in commercial projects and BLA submissions in the coming years, particularly for bispecific ADCs and dual-payload ADCs [51][52] Other Important Information - The company has made significant advancements in innovation, particularly in linker-payload technologies, which are expected to drive future growth [21][29] - The company has a strong cash position of RMB 7.5 billion, supporting its capital investment plans [48] Q&A Session Summary Question: Outlook for 2026 revenue and earnings growth - Management expects consolidated CDMO revenues to maintain a growth rate around 35% for 2026, despite potential margin impacts from BioDlink integration [60][62] Question: Expectation of IP income in 2026 - Management indicated that while licensing income is not regularly predictable, ongoing R&D investments may lead to more licensing deals in the future [64][66] Question: Backlog composition and commercial ramp-up - Management noted that most contracts are still in preclinical or clinical stages, with expectations for a gradual shift towards more commercialized projects in the coming years [70][72] Question: Global ADC supply and capacity expansion - Management believes that the global supply situation remains tight, with demand outpacing new capacity additions from competitors [81] Question: BioDlink's biosimilar business and backlog integration - Management confirmed that BioDlink's biosimilar business is being phased out, and existing contracts will be honored before signing new ones [89] Question: AI applications in drug discovery - Management acknowledged that AI applications in drug discovery are still in early stages, with ongoing monitoring of developments in this area [90]

Financial Data and Key Metrics Changes - For fiscal 2025, the company generated net sales of $7.65 billion, an increase of approximately 3% compared to the previous year, with adjusted EBITDA of $931 million and adjusted diluted EPS of $2.97, reflecting a 7% increase [9][34][37] - Gross margin for the year was 26.9%, up 30 basis points from fiscal 2024, driven by higher private label penetration and disciplined purchasing [35][36] - Operating cash flow was $650 million, representing a conversion rate of approximately 70% from adjusted EBITDA, with a free cash flow yield of 5.8% [38] Business Line Data and Key Metrics Changes - Municipal projects accounted for 44% of sales, with low- to mid-single-digit percentage growth, while non-residential sales were roughly flat, and residential lot development declined low double digits [5][10][34] - Average daily net sales for meter products grew 12% in the fourth quarter and mid-single digits for the year, following a strong prior year growth comparison of 32% [12][34] - The company achieved 3 points of organic above-market growth in fiscal 2025, driven by sales initiatives and geographic expansion [12][34] 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 last year, with the company holding an estimated 20% market share in the U.S. [5][6] - 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][41] - Investments are being made in product offerings, capabilities, and geographic expansion, with a focus on smart metering and treatment plant solutions [20][24] - The company plans to open a record 7-10 greenfield locations in the coming year to enhance market presence [25][40] Management's Comments on Operating Environment and Future Outlook - Management remains cautious about the private construction market due to geopolitical volatility and interest rate uncertainties, while expressing confidence in the stability of the municipal market [40][41] - The company expects net sales for fiscal 2026 to be in the range of $7.8 billion to $7.9 billion, with adjusted EBITDA of $950 million to $980 million [39][40] Other Important Information - The company implemented approximately $30 million in annualized cost actions during fiscal 2025, with $6 million recognized this year [33] - The company has repurchased over 20% of its original shares outstanding since its 2021 IPO, reflecting a commitment to return capital to shareholders [38] Q&A Session Summary Question: Growth disconnect between Core & Main and competitors - Management acknowledged differences in market presence and product mix, noting strong share growth in smart metering and treatment plant areas [45][46] 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 [50][51] Question: Current market conditions and pricing - Management is monitoring the impact of geopolitical events on commodity prices, particularly resin prices, which may affect product pricing [57][59] Question: Growth investments in data centers and treatment plants - Management plans to invest in additional resources for treatment plant initiatives, enhancing capabilities for larger projects [62][64] Question: EBITDA guidance and components - Management provided insights on the guidance range, emphasizing the importance of pricing stability and potential inflation impacts [69][72] Question: M&A expectations for 2026 - Management expressed confidence in the M&A pipeline, anticipating a return to a more normalized cadence of acquisitions [75][76] Question: Growth expectations for the meters business - Management expects continued low double-digit growth in the meters business, supported by a strong pipeline of large projects [80][81]

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 reached $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, driven by higher legal and payroll expenses [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 and conversion rates, which rose to 70% from 50% in Q1 [8][19] - The company expanded its capabilities to target the adolescent and young adult (AYA) market, enhancing its outreach to high-prescribing targets [6][9] 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 [9][10] - 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 for global expansion and sustained growth, with a focus on execution and enhancing its commercial team [11][19] - Strategic initiatives include strengthening medical affairs and expanding clinical evidence generation to support product adoption [12][15] - The company plans to leverage partnerships with academic institutions to drive research and enhance product credibility [12][15] 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 operational efficiency [6][11] - The company anticipates generating positive cash flow in Q1 2026, with early collection of receivables expected to benefit cash position [23] - Management highlighted the importance of ongoing dialogue with regulatory authorities regarding potential label expansions for PEDMARK [30] 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 Norgine partnership is expected to contribute significantly to financials in the second half of 2026, with multiple launches planned across Europe [34][36] 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, but long-term studies show no difference in survival outcomes [25][26] 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 [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 due to commercial expansion [31][32] Question: When will initial revenue from the Norgine partnership be expected? - Material contributions from the Norgine partnership are anticipated in the second half of 2026 following pricing approvals [58][60] Question: How is the company addressing the growth of treated patients in Q4? - The company is seeing significant growth in AYA patients and is focusing on both existing and new accounts to drive further penetration [51][52]

Financial Data and Key Metrics Changes - The company reported a cash and cash equivalent position of $93 million as of December 31, 2025, with short-term liquidity estimated at approximately $85 million [35] - Anticipated spending over the next 12 months is projected to be around $190 million to $200 million, which includes ramping up manufacturing and assembly of the first Valo aircraft [36][70] - The annual spend for 2025 was in line with guidance of $110 million to $125 million, which is a fraction of what main competitors spent [35] Business Line Data and Key Metrics Changes - The Valo aircraft is positioned as the highest quality EVTOL aircraft in development globally, with a focus on safety, performance, and efficiency [12] - The company is developing a battery technology that is a core in-house technology and a key value driver, with plans to expand battery manufacturing capabilities [30][31] Market Data and Key Metrics Changes - The company is actively participating in government-backed programs in the UK and Europe to support the introduction of eVTOL technologies, including the Future Flight Challenge [27] - The market response to the Valo aircraft has been described as extraordinary, indicating strong interest from airline partners and stakeholders [10] Company Strategy and Development Direction - The company aims to be a leader in the hybrid electrics defense space and is deepening discussions with militaries worldwide [14] - The strategy includes a focus on partnerships with tier one aerospace suppliers to minimize certification risk while developing proprietary battery technology [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress towards certification, emphasizing a disciplined approach to flight testing and collaboration with regulatory authorities [37] - The company is optimistic about the future, with plans to start building the Valo by the end of the year and flying early next year [107] Other Important Information - The company has received significant support from the UK government, amounting to around $100 million, which reflects the UK’s commitment to aerospace [40] - The company is exploring various options for capital raising and will execute when it is the right time for the business [37] Q&A Session Summary Question: Is there a credible likelihood of meaningful state financial support from the UK? - Management confirmed that they have had tremendous support from the UK government, which has committed around $100 million to the aerospace sector [40] Question: Are there any regulatory hurdles that the company is waiting for regarding the pilot full transition? - Management indicated that the last few tests are in progress, and weather has been a significant factor affecting flight testing [46][80] Question: What is the status of strategic discussions and potential partnerships? - Management stated that ongoing conversations with strategic partners are expected to deepen following the successful transition [48] Question: What are the R&D and CapEx plans over the next 12 months? - The anticipated spending of $190 million to $200 million will cover all necessary developments, including the build of the first Valo and the expansion of the battery center [70] Question: How has the selection of Evolito as the EPU supplier been received? - Management expressed confidence in Evolito's certification processes and their fit for the Valo project, highlighting their proven technology [100]

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] - Operating expenses for Q4 totaled 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 launch of LNZ100 has resulted in over 45,000 boxes sold, prescribed by more than 10,000 eye care professionals [5][26] - The product is showing strong refill behavior, with patients moving from one-month to three-month prescriptions [48][72] Market Data and Key Metrics Changes - Presbyopia affects approximately 128 million people in the U.S., representing a significant market opportunity [18] - The company is seeing a broad base of prescribing physicians, with over 55% of doctors having written VIZZ multiple times [20] Company Strategy and Development Direction - The company aims to build a new treatment category for presbyopia, focusing on increasing physician adoption and consumer awareness [16][19] - The sales force is expanding from 88 to 117 representatives to increase call frequency and broaden coverage of eye care professionals [24][25] - A direct-to-consumer campaign featuring Sarah Jessica Parker has been launched to drive consumer engagement [27][28] Management's Comments on Operating Environment and Future Outlook - Management is optimistic about the product's performance and the potential for a large, under-penetrated market [16][30] - The company expects to see an acceleration in new patient starts as prescriber habits build and consumer awareness grows [41] Other Important Information - The company has made significant progress in global expansion, with multiple NDA submissions anticipated in early 2027 [39][40] - The direct-to-consumer campaign is showing early positive indicators, with website traffic increasing significantly [13][28] Q&A Session Summary Question: Can you discuss the sampling dynamic to NRX and retention? - Management is encouraged by refill rates and believes the sampling strategy is effective, with patients returning for reorders [46][48] 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 [50][51] 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 targeted and non-targeted groups, with many new prescribers who had not previously written Vuity now adopting 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 comfortable offering it to a broader patient population [59][63] Question: How are you planning to correct misconceptions about VIZZ's target population? - The company is actively working to educate prescribers on the broader applicability of VIZZ beyond early presbyopes [64]

Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and marketable securities totaled $36.4 million [22] - 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 [22] - The total net loss for Q4 2025 was $14.7 million, and for the full year, it was $54.7 million [22] Business Line Data and Key Metrics Changes - The NDA submission in June 2025 marked a transition for the company from clinical development to a commercially focused enterprise [4] - The company aims to make cytisinicline available to 25 million smokers and nearly 18 million vapers in the U.S. [4] - The ORCA-OL long-term exposure trial demonstrated cytisinicline's safety profile, showing strong tolerability and excellent patient satisfaction [6] Market Data and Key Metrics Changes - Approximately 25 million adults in the U.S. smoked cigarettes in 2024, with over 15 million attempting to quit annually [10] - There are 6 million COPD smokers in the U.S. with limited options to help them quit, highlighting the need for effective treatments [6] Company Strategy and Development Direction - The company is focused on launching cytisinicline as the first FDA-approved treatment for nicotine dependence in 20 years [5] - Achieve Life Sciences is building a scalable, data-driven commercial model to effectively target physicians and patients [7] - The partnership with Adare Pharma Solutions aims to secure the supply chain and reduce risks associated with international pharmaceutical importation [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory progress and the potential for cytisinicline to deliver a new treatment option for nicotine dependence [16] - The company is committed to addressing the public health crisis of nicotine dependence and is actively building for the product launch [24] - The management emphasized the importance of a controlled and successful launch, ensuring all processes are in place [32] Other Important Information - The company received the FDA Commissioner's National Priority Voucher for vaping cessation, which provides an expedited review timeline [16] - The Willpower awareness campaign was launched to reframe the conversation around nicotine dependence as a medical condition [11] Q&A Session Summary Question: Can you talk about the critical path between a late June NDA approval and a first half launch? - The company needs to ensure drug availability in the supply chain before market entry, with all trade and distribution processes ready upon drug availability [27][28] Question: Did you imply that the manufacturer in the NDA will not be supplying commercial product, rather Adare will? - The company confirmed that the PDUFA date remains unchanged, and the decision to transfer manufacturing to the U.S. was made to ensure supply chain security [33] Question: Can you talk about healthcare provider awareness and additional work in 2026? - The company has been conservative in spreading awareness prior to product availability but plans to ramp up educational efforts as the launch approaches [38] Question: What is the status of the FDA dialogue on the vaping indication since receiving the CMPV? - Discussions with the FDA have focused on protocol approval, with site selection for the ORCA-V2 phase III trial already underway [40][41] Question: How robust is the raw plant material supply chain? - The company has been stockpiling starting material and expects to have more than three years' supply by the time of launch [56] Question: What is the cytisinicline dosing schedule and potential compliance concerns? - High adherence rates were reported in trials, with participants finding the dosing schedule manageable and effective in addressing cravings [58][59] 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 [62][65]

Financial Performance - The company achieved net revenue of $103.1 million for the full year 2025, marking a 19% year-over-year growth and exceeding $100 million for the first time in its history [4] - Gross margins expanded by approximately 200 basis points to 93% for the full year 2025, with a significant reduction in net loss from continuing operations by 80% to $1.5 million [5] - Adjusted EBITDA improved by 86% to $17 million for the full year 2025, and cash provided by operations was $6.8 million compared to cash used in operations of $24,000 in 2024 [5][26] Business Line Performance - In Q4 2025, net revenue was $27.5 million, representing a 5% year-over-year growth, primarily driven by sales of soft tissue products [6] - Excluding $1.8 million of BIASURGE sales from the previous year, Q4 2025 net revenue increased by 13% year-over-year [8] - The company ended 2025 with over 450 contracted distributors, up from over 350 at the end of 2024, indicating significant growth in its distributor network [9] Market Performance - The company successfully sold into over 1,450 healthcare facilities by the end of 2025, up from over 1,300 in 2024, with products contracted or approved for sale in over 4,000 facilities [10] - The surgeon customer base saw strong year-over-year growth, with new users added across various specialties, although penetration within existing facilities remains low [11] Strategic Direction - The company is focused on the surgical market, having ceased operations of the Tissue Health Plus segment, and aims to bring innovative products to the operating room [12][13] - The BIASURGE product received an Innovative Technology contract from Vizient, providing access to approximately 1,800 healthcare facilities [15] - The company plans to introduce the OsStic synthetic injectable bone bioadhesive to the U.S. market in Q1 2027, which is expected to be a significant addition to its product portfolio [19][20] Management Commentary - Management expressed confidence in the company's positioning as a focused, pure-play surgical company with a commitment to driving growth through its commercial strategy [30][32] - The company anticipates full-year 2026 net revenue to range from $116 million to $121 million, representing a growth of approximately 13%-17% compared to 2025 [27] - Management highlighted the importance of clinical evidence and economic studies in strengthening relationships with healthcare facilities and driving product adoption [41][42] Other Important Information - The company is investing in its field sales team and R&D initiatives to support growth and enhance its competitive position in the surgical market [33][34] - The company has made significant progress in expanding its intellectual property portfolio, converting provisional patent applications into non-provisional filings [18] Q&A Session Summary Question: Impact of Vizient contract on growth - Management acknowledged the significance of the Vizient contract and indicated that it would take time to educate facilities, but it provides a strong growth opportunity for 2026 [39][40] Question: CellerateRX growth and reimbursement - Management emphasized the importance of clinical evidence for CellerateRX and expressed confidence that the economic study would enhance relationships with facilities and positively impact growth [41][42]