Financial Data and Key Metrics Changes - Fiscal year 2025 was the most successful year in the history of the company, with record product sales growth of 163% to $9.1 million [3] - In Q4 2025, product revenue increased 907% to $2.7 million compared to $0.3 million in Q4 2024 [14] - Product gross margins improved to 55.8% in Q4 2025 from 51.8% in Q4 2024 [5] - Net loss in Q4 2025 improved by 52% to $1.6 million, or $0.03 per share, compared to a net loss of $3.4 million, or $0.11 per share, in the same quarter of the prior year [16] - Total operating expenses decreased 2% to $2.9 million in Q4 2025 compared to $3.0 million in Q4 2024 [15] Business Line Data and Key Metrics Changes - The company received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system and advanced the development of spinal cord stimulation electrodes for lower back pain [4] - The drug delivery program using SEEG platform electrode technology has garnered significant physician interest, with potential partnerships for gene therapy and glioblastoma drug delivery [6] - The OneRF brain ablation system continues to gain traction, with positive clinical outcomes reported [11] Market Data and Key Metrics Changes - The company is pursuing several market opportunities as potential revenue drivers, particularly in drug delivery and pain management [5] - Interest from strategic partners in using the technology for various therapies indicates a growing market potential [6] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a forecast from distribution partner Zimmer Biomet [4] - The strategy includes expanding the product portfolio and pursuing international commercial expansion through ISO 13485 certification [4] - The company aims to leverage existing technologies for new applications in pain management and drug delivery [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving increased revenue from the OneRF ablation system and preparing for future international sales [17] - The company anticipates significant growth opportunities in drug delivery and pain management platforms [7] Other Important Information - The company raised $8.2 million in capital, strengthening its balance sheet [3] - As of September 30, 2025, the company had cash and cash equivalents of $6.6 million, compared to $1.5 million a year earlier [16] - The company has 17 issued and pending patents, enhancing its intellectual property portfolio [12] Q&A Session Summary Question: Will there be more procedures for facial pain before year-end? - Management indicated that there are three other centers planning cases, pending some ancillary equipment [19][20] Question: Were the two procedures done back to back? - Yes, both cases were performed back to back, which allows for better scheduling and support [21][22] Question: Will there be more orders from the large pharma player for drug delivery? - Additional orders are expected around mid-year as the company prepares to ship preclinical devices [23] Question: What is the status of the epilepsy registry? - The registry is expected to be established by Q2, pending internal approvals from participating sites [24] Question: What strategies are being implemented to raise patient awareness? - The company is partnering with organizations like CURE and the Epilepsy Foundation to increase visibility [25][26] Question: Can you elaborate on the distribution agreement with Zimmer Biomet? - The agreement has expanded to include the brain ablation system, with potential for further growth [27][33] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, which have not hindered adoption by neurosurgeons [34][35]

Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $2.3 billion, a 5.4% year-over-year increase, driven by 4.8% organic growth and contributions from a recent acquisition in Ireland [15][16] - Adjusted EPS was $0.88, reflecting a $0.26 headwind from prior-year self-insurance adjustments, indicating strong underlying performance when adjusted [17][24] - Adjusted EBITDA was $124.2 million with a margin of 5.6%, compared to $125.6 million and 6% in the prior year, impacted by prior-year self-insurance adjustments [17][18] Business Line Data and Key Metrics Changes - Business and Industry (B&I) revenue surpassed $1 billion, up 2% year-over-year, with operating profit of $80.6 million and a margin of 7.7% [18] - Aviation revenue grew 7% to $296.7 million, with operating profit of $16.8 million and a margin of 5.7% [18][19] - Manufacturing and Distribution (M&D) revenue increased 8% to $417.4 million, with operating profit of $35.8 million and a margin of 8.6% [19][20] - Education revenue rose 2% to $233.7 million, with operating profit increasing 44% to $18.8 million and margins expanding to 8% [20][21] - Technical Solutions revenue increased 16% to $298.7 million, with operating profit rising 32% to $37.1 million and a margin of 12.4% [21] Market Data and Key Metrics Changes - The company noted strong demand across key end markets, particularly in technical solutions, aviation, and manufacturing and distribution, indicating a healthy market environment heading into fiscal 2026 [10][11] - The acquisition of WGNSTAR is expected to strengthen the company's position in the semiconductor market, which is experiencing multi-year growth due to U.S. semiconductor onshoring [8][10] Company Strategy and Development Direction - The company is focused on enhancing its portfolio and expanding technical and data-enabled capabilities, aiming for long-term growth [29][30] - The acquisition of WGNSTAR is seen as a strategic move to penetrate the semiconductor sector, which has a low current outsourcing rate, providing significant growth opportunities [8][54] - The company plans to continue investing in AI capabilities and ERP implementation to improve operational efficiency and unlock new revenue streams [7][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's momentum heading into fiscal 2026, expecting organic revenue growth of 3%-4% and adjusted EPS in the range of $3.85-$4.15 [11][24] - The restructuring program is expected to yield annual savings of $35 million, with most benefits realized in fiscal 2026 [9][11] - Management highlighted the importance of maintaining operational excellence and adaptability in a complex operating environment [10][29] Other Important Information - The company ended the year with total indebtedness of $1.6 billion and available liquidity of $681.6 million [22][23] - Free cash flow for the fourth quarter was $112.7 million, significantly improved from the prior year [23] Q&A Session Summary Question: What are the drivers behind the relatively flat margin outlook for 2026 despite restructuring savings? - Management explained that the new Segment Operating Margin metric reflects the operating health of the business and incorporates some mix and pricing decisions affecting margins [32] Question: Can you discuss the strategic attraction of the WGNSTAR acquisition? - The acquisition is compelling due to the growth potential in the semiconductor space, allowing the company to penetrate fabrication centers where it previously could not operate [33][35] Question: What is the outlook for pricing concessions in the B&I business? - Management indicated that pricing discussions have stabilized and are not as dramatic as in previous quarters, reflecting a normalization in the market [38] Question: Can you provide details on the remaining pieces of the ERP roadmap for 2026? - The majority of transactions are now on the new ERP system, with a few less complex groups remaining to be integrated, which is expected to enhance cash flow [40] Question: What is the expected free cash flow for 2026, considering one-time items? - The normalized free cash flow target is around $250 million, with several one-time costs expected to reduce this figure to approximately $185 million [42] Question: What is the expected EBITDA margin for WGNSTAR and the anticipated synergies? - WGNSTAR has mid-teen EBITDA margins, and the company expects significant revenue synergies from cross-selling opportunities in the semiconductor space [56]

Financial Data and Key Metrics Changes - GAAP revenue for Q3 2025 was $12.7 million, a decline year-over-year primarily due to the absence of approximately $11.5 million of maritime revenue from Q3 2024 [19] - Non-GAAP operating loss for Q3 2025 was -$13.9 million compared to -$6.1 million in Q3 2024, with adjusted EBITDA at -$11.8 million versus -$3.1 million a year ago [21][22] - The company ended Q3 2025 with $96.8 million in cash, cash equivalents, and marketable securities, utilizing $20.4 million of free cash flow during the quarter [22] Business Line Data and Key Metrics Changes - The company experienced triple-digit growth in commercial and government contracts, particularly in weather and security sectors [5] - The satellite manufacturing throughput doubled per year while maintaining flat headcount, indicating improved operational efficiency [6][15] - The backlog of remaining performance obligations exceeded $200 million, providing substantial revenue visibility moving into 2026 [22][23] Market Data and Key Metrics Changes - Demand for weather data in Europe, especially from Germany, remained robust, with significant contracts secured from NOAA and EUMETSAT [6][7] - The European Space Agency pledged EUR 22 billion in new subscriptions for the next three years, with Germany contributing EUR 5 billion, enhancing the company's strategic positioning in Europe [13] - The U.S. government defense market continues to expand, with a shared ceiling of $151 billion for the Missile Defense Agency's multi-award Shield IDIQ contract, positioning the company for future task orders [10][11] Company Strategy and Development Direction - The company aims to become Adjusted EBITDA and operating cash flow break-even by Q4 2026, focusing on cost management and aligning its cost base with revenue expectations [24] - The strategic emphasis is on expanding partnerships with commercial entities, particularly in the defense sector, as the U.S. government pushes for more commercial partnerships [7][11] - The upcoming launch of a microwave sounding satellite is expected to address a multi-billion-dollar global atmospheric sounding need, enhancing the company's product offerings [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's technology advantage and expanding capacity, despite timing impacts from the U.S. government shutdown [17] - The company anticipates over 30% revenue growth in 2026, supported by contracted programs and an expanding backlog [25] - Management highlighted the importance of the NOAA relationship and the growing demand for radio frequency geolocation services as key drivers of future growth [48] Other Important Information - The company has secured its largest radio occultation contract from NOAA, which is three times the size of last year's contract in annual sounding volume [6] - The company is the only one in Germany with deep in-space radio frequency expertise, enhancing its competitive edge in the European market [12] - The company is actively working through an SEC subpoena, with no significant updates to share at this time [44] Q&A Session Summary Question: What gives confidence in the 30% growth estimate for next year? - Management noted that over $10 million shifted across the calendar year and emphasized the urgency for commercial partnerships in Europe, particularly with large budgets emerging from Germany [27][28] Question: Is the NASA Earth observation contract expected to be renewed? - Management indicated that while the contract is delayed due to the government shutdown, they do not believe it is lost and expect it to be signed [29][30] Question: How should cash balance be viewed going forward? - Management expressed confidence in finishing the year with a strong cash balance, despite timing issues related to revenue collection and ongoing legal fees [31][32] Question: Can you break down the revenue reduction in the second half? - Management detailed that approximately $6-$8 million was related to a percent complete contract, with additional losses due to the government shutdown impacting contract signings [33][34] Question: What is the contribution mix of government contracts expected to be by the end of 2026? - Management confirmed that government contracts will continue to be a significant portion of growth, particularly with the delayed Earth observation contract and ongoing relationships with NOAA [45][46]

Financial Data and Key Metrics Changes - The company reported a revenue increase of over 19% year-over-year in Q2, with adjusted EBITDA growing by 8% year-over-year, reaching $60 million [4][5][16] - Adjusted earnings per share rose to $0.65, up from $0.60 in the prior year quarter [14] - The adjusted EBITDA margin improved to 18.5% compared to 20% a year ago [5][16] Business Line Data and Key Metrics Changes - In the consumer products segment, net sales increased by 3% to $120 million, with adjusted EBITDA remaining flat at $15 million [20] - The building products segment saw a 32% year-over-year growth in net sales to $208 million, driven by higher volumes and contributions from the Elgen acquisition [21] - Excluding Elgen, building products net sales grew by 16% year-over-year, reflecting strength across multiple categories [21] Market Data and Key Metrics Changes - The company noted cautious consumer sentiment and muted construction activity impacting market conditions, but still managed to gain market share [12] - The performance of joint ventures was highlighted, with WAVE contributing $26 million in equity earnings, while ClarkDietrich's earnings were lower due to a challenging market environment [22] Company Strategy and Development Direction - The company aims to optimize its business through organic growth and strategic acquisitions, with a focus on increasing margins [5][6] - The planned acquisition of LSI, a leader in metal roofing components, is expected to enhance the company's position in engineered building systems and create long-term shareholder value [6][11] - The company continues to leverage the Worthington Business System, focusing on innovation, transformation, and M&A to maximize success [6][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the current environment and positioning for long-term growth despite challenges in the housing market and construction activity [12][13] - The company is optimistic about growth prospects in the back half of the fiscal year, particularly in consumer products and building products [20][21] Other Important Information - The company declared a quarterly dividend of $0.19 per share, payable in March 2026 [19] - The acquisition of LSI is expected to close in January 2026 and will be funded primarily with cash on hand [19][11] Q&A Session Summary Question: Can you expand on the strategy for growth from the acquisition of LSI? - Management highlighted the complementary nature of acquisitions and the focus on leveraging manufacturing expertise and innovation to create value [26][27] Question: What are the opportunities involved in data centers? - Management noted that several segments, including WAVE and ClarkDietrich, provide products for data centers, indicating a meaningful growth opportunity [31][33] Question: What drives the healthy margin profile of LSI? - Management indicated that LSI's business is driven by resilient retrofit demand and strong customer relationships, contributing to its high margins [39][40] Question: How much of the building products growth is due to pricing versus volume? - Management stated that the growth was primarily driven by volume, with a focus on gaining market share through innovation [42][44] Question: What is the outlook for ClarkDietrich? - Management expects no worse than flat sequential performance moving forward, with a focus on cost-saving initiatives [46][47] Question: How does the company plan to balance capital allocation? - Management expressed a balanced approach to capital structure, considering strategic M&A and returns to shareholders while maintaining growth [50]

Financial Data and Key Metrics Changes - Net revenue for Q1 was $8.3 billion, at the high end of guidance, with core operating income of $454 million and a core operating margin of 5.5% [4][5] - Core diluted earnings per share for Q1 was $2.85, at the upper end of guidance, while GAAP diluted earnings per share was $1.35 [4][5] - The company ended the quarter with a net debt to core EBITDA ratio of 1.2 times and cash balances of $1.6 billion [7] Performance by Business Segment - Regulated industries generated $3.1 billion in revenue, up 4% year over year, with a core operating margin of 5.8% [5][14] - Intelligent Infrastructure revenue was $3.9 billion, driven by strength in cloud and data center infrastructure, with a core operating margin of 5.2% [5][12] - Connected Living and Digital Commerce revenue was $1.4 billion, with a core operating margin of 5.5% [6][15] Market Data and Key Metrics Changes - Intelligent Infrastructure is expected to see revenue growth of 42% year over year in Q2, driven by strong demand across various sectors [8][12] - Regulated industries are projected to generate $2.78 billion in revenue for Q2, reflecting a 2% year-over-year increase [8] - Connected Living and Digital Commerce revenue is expected to decline by 10% in Q2 due to planned program attrition [8] Company Strategy and Development Direction - The company is focused on margin expansion, capital efficiency, and sustained cash generation, with a strong emphasis on AI-related revenue growth [9][16] - The acquisition of Hanley Energy is expected to enhance capabilities in modular power distribution and energy systems for next-generation data centers [12][49] - The company anticipates a diversified revenue mix, with Intelligent Infrastructure leading growth, and expects to raise full-year guidance for revenue and core EPS [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the diversified portfolio and the ability to navigate changing market conditions [9][17] - The outlook for fiscal 2026 has been raised, with expectations of approximately $32.4 billion in revenue, an increase of $1.1 billion from prior estimates [16] - Management noted that all three segments are contributing to the better-than-expected performance, with Intelligent Infrastructure showing particularly strong results [11][17] Other Important Information - The company repurchased $300 million of shares under its existing share repurchase authorization during Q1 [7] - The core tax rate for Q2 and the full year is expected to be 21% [8] Q&A Session Summary Question: Can you provide more color on the new wins in the intelligent infrastructure space? - Management highlighted that the intelligent infrastructure segment is outperforming, with significant revenue increases driven by recent program wins and strong demand in cloud and data center infrastructure [22][23] Question: What are the prospects for operating margins in fiscal 2027? - Management indicated that while they are focused on FY26, they feel optimistic about achieving above 6% operating margins in FY27, driven by better mix and capacity utilization [27][28] Question: How is the healthcare business expected to evolve? - Management noted that the healthcare business remains solid, with ongoing demand across various platforms, and they are actively pursuing M&A opportunities to enhance capabilities [39][40] Question: What is the outlook for the automotive segment? - Management remains cautiously optimistic about the automotive segment, expecting potential upside in 2027 and 2028 as they continue to invest in powertrain-agnostic technologies [55][56] Question: Can you discuss the impact of the Hanley acquisition? - Management emphasized that the Hanley acquisition will enhance their capabilities in power and energy management solutions, providing a platform for ongoing revenue streams [49][50]

Summary of 4D Molecular Therapeutics Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (NasdaqGS:FDMT) - **Focus**: Development of gene therapy for cystic fibrosis (CF) using AAV vectors Industry Context - **Cystic Fibrosis**: A genetic disorder affecting over 100,000 people globally, with a significant unmet need for effective therapies - **Current Treatments**: Existing modulators have improved outcomes for some patients, but many remain without effective options Key Points and Arguments Gene Therapy Development - **Need for Effective Gene Delivery**: The company emphasizes the urgent need for effective AAV vectors for gene delivery in CF, as previous attempts have failed due to ineffective delivery and expression [2][3] - **AAV Vector Technology**: Utilizes a novel AAV vector (A101) designed to penetrate mucus, transduce all airway cell types, and resist pre-existing immunity [2] - **Administration Method**: The therapy (4D-710) is administered via the FDA-approved AeroEclipse II nebulizer, ensuring widespread delivery throughout the airways [2] Clinical Trial Design and Results - **Phase 1 Trial Focus**: The trial aimed to find the optimal dose for safety and CFTR expression levels, with a focus on dose-finding and safety assessments [4][5] - **Dose Ranging**: Initial doses started at 1 x 10^15 vector genomes, with adjustments made based on safety and expression data [5] - **Safety Profile**: The lower dose (2.5 x 10^14 vector genomes) showed excellent safety and tolerability, with no significant adverse events beyond day 14 [8][9] Clinical Activity and Efficacy - **Endpoints**: The trial included multiple endpoints such as FEV1, Lung Clearance Index (LCI), and quality of life measures [18][31] - **Improvements Observed**: Participants receiving the selected lower dose showed greater improvements in clinical endpoints compared to those on higher doses [26][30] - **Durability of Expression**: Data indicated that the AAV-based approach could deliver durable CFTR expression for one to three years, supporting the decision to proceed with the selected dose in phase 2 [32][34] Regulatory Considerations - **FDA Engagement**: The company has had productive discussions with the FDA regarding the use of LCI as a primary efficacy endpoint, especially in pediatric studies [42][46] - **Future Plans**: The company plans to leverage data from ongoing studies to inform future regulatory submissions and potential accelerated approval pathways [66] Financial and Strategic Outlook - **Funding**: The program is fully funded by the Cystic Fibrosis Foundation, alleviating financial pressure on the company [53] - **Partnership Potential**: The company is open to future partnerships but aims to retain rights until more data is available [72] Additional Important Insights - **Patient Variability**: The variability in patient responses highlights the need for a diverse participant pool in future trials [39][41] - **Redosing Strategy**: The company anticipates a redosing interval of 12 to 18 months based on durability data, with LCI serving as a leading indicator for treatment effect [80] This summary encapsulates the critical aspects of the conference call, focusing on the company's innovative approach to treating cystic fibrosis through gene therapy and the ongoing clinical development of its lead product, 4D-710.

Veru (NasdaqCM:VERU) Q4 2025 Earnings Call December 17, 2025 08:00 AM ET Company ParticipantsRohan Mathur - Biopharma Equity Research AssociateMichele Greco - Chief Financial Officer and Chief Administrative OfficerMitchell Steiner - Chairman, CEO and PresidentSam Fisch - Executive Director of Investor Relations and Corporate CommunicationsConference Call ParticipantsNone - AnalystWilliam Wood - Research AnalystOperatorGood morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. ...

4D Molecular Therapeutics (NasdaqGS:FDMT) Update / Briefing December 17, 2025 08:00 AM ET Company ParticipantsJulian Pei - Head of Investor RelationsDaniel Giraldo - VP of Equity ResearchFelix Ratjen - Paediatric RespirologistJonathan Miller - Managing Director of Biotech and Pharma Equity ResearchJennifer Taylor Cousar - Professor of Internal Medicine and PediatricsGena Wang - Managing Director of Biotech Equity ResearchRyan McElroy - Equity Research AssociateDavid Kirn - Founder and CEOConference Call Par ...

Veru (NasdaqCM:VERU) Q4 2025 Earnings Call December 17, 2025 08:00 AM ET Company ParticipantsRohan Mathur - Biopharma Equity Research AssociateMichele Greco - Chief Financial Officer and Chief Administrative OfficerMitchell Steiner - Chairman, CEO and PresidentSam Fisch - Executive Director of Investor Relations and Corporate CommunicationsConference Call ParticipantsWilliam Wood - Research AnalystOperatorGood morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. All participa ...

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [27] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the phase 2b obesity clinical study for Enobosarm [25] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [25] Business Line Data and Key Metrics Changes - The company sold the FC2 female condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after selling costs, but incurred a loss of approximately $4.1 million on the sale [22][23] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [25] Market Data and Key Metrics Changes - The company reported that as of September 30, 2025, cash, cash equivalents, and restricted cash balance was $15.8 million, down from $24.9 million as of September 30, 2024 [28] - The net working capital was $11.1 million on September 30, 2025, compared to $23.4 million on September 30, 2024 [29] Company Strategy and Development Direction - The company is focusing exclusively on drug development following the sale of the FC2 female condom business, which represents a strategic shift [23] - The planned phase 2b plateau clinical trial will target patients with a BMI greater than or equal to 35 and age greater than or equal to 65, aiming to assess the ability of Enobosarm treatment to break through the weight loss plateau [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory landscape evolving for muscle-preservation drugs for obesity treatment, with at least two possible regulatory pathways for Enobosarm [15] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][42] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million [24] - The company used cash of $30 million for operating activities in fiscal 2025, compared to $21.7 million in the prior year [29] Q&A Session Summary Question: Will any GLP-1 be allowed in your phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently being the placeholder [32][33] Question: How does the FDA's guidance affect the phase 3 transition? - Management explained that the phase 2b study is designed to mirror phase 3 criteria, allowing for a clear understanding of incremental weight loss and functional endpoints [34][35] Question: What patient population is being targeted in the Plateau study? - The focus is on patients over 65 with physical limitations, as this group is seen as most in need and informative for assessing physical function [37][39]