Clearside Biomedical, Inc. (CLSD) Q4 2024 Earnings Conference Call March 27, 2025 04:30 PM ET Company Participants Jenny Coben - Investor Relations HostGeorge Ledeske - Chief Executive OfficerDaniel Gatua - Questioner, ShardaCharlie Degnan - Chief Financial OfficerAndreas Argarides (via Eka) - Questioner, OppenheimerDevanjana Chatterjee - Questioner, Jones TradingDr. Victor Chong - Chief Medical Officer and Head of Research and DevelopmentMr. Leszczyk - Conference Operator/ModeratorPaul - Questioner (Affili ...

Strata Skin Sciences, Inc. (SSKN) Q4 2024 Earnings Conference Call March 27, 2025 04:30 PM ET Company Participants Dr. Dolev Raffaele - Chief Executive OfficerJohn Gillings - Vice President of FinanceOperator - Conference Call OperatorLouie Thoma - Investor Relations Representative, Core IR Conference Call Participants Jeremy Pearlman - Analyst, Maxim GroupJeffrey Cohen - Analyst, Leidenberg Thalmann Operator Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Strata Sciences, ...

Barfresh Food Group Inc. (BRFH) Q4 2024 Earnings Conference Call March 27, 2025 04:30 PM ET Company Participants Ricardo Del Coste - CEO, Barfresh GroupLisa Rogers - CFO, Food GroupOperator - Teleconference OperatorOperator - Teleconference OperatorModerator - Conference Call Moderator Conference Call Participants Nicholas Sherwood - Analyst, Maxim Group Moderator Food Group CFO, Lisa Rogers. Following prepared remarks, we will open the call for your questions. The discussion today will include forward-look ...

lululemon athletica inc. (LULU) Q4 2024 Earnings Conference Call March 27, 2025 04:30 PM ET Company Participants Jeff Walker - Vice President at the Howard GroupRandy Boomhauer - CEO and President of SimatrixMJ Kent - CFO of Simatrix Jeff Walker Looks like everyone's coming in. So first, thank you everybody for joining us today. I'm Jeff Walker, Vice President at the Howard Group. We're speaking with Randy Boomhauer, CEO and President, and MJ Kent, who is CFO of Simatrix. We'll go through the presentation d ...

Pulse Biosciences, Inc (PLSE) Q4 2024 Earnings Conference Call March 27, 2025 04:30 PM ET Company Participants Luella - Conference OperatorNot Provided - Conference Call Moderator (Operator Instructions)Tripp Taylor - Investor RelationsNot Provided - Legal/Compliance Disclaimer RepresentativePaul LaViolette - Co‐Chair of the Board and Chief Executive OfficerJohn Skinner - Chief Financial OfficerPaula Violet - Closing Remarks Luella Thank you for standing by. My name is Luella, and I will be your conference ...

Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2024, was approximately $37.6 million or $1.03 per basic and diluted share, compared to a net loss of $42.9 million or $1.39 per basic and diluted share for the prior year [21] - Research and development expenses for 2024 were $22.6 million, down from $27.8 million in 2023, primarily due to decreases in clinical costs, personnel costs, and professional fees [22] - General and administrative expenses for 2024 were $13.8 million, compared to $15.3 million in 2023, reflecting a decrease in professional fees and facilities costs [23] - Total operating expenses for 2024 were $36.3 million, compared to $43 million in 2023 [23] - The company's cash balance as of December 31, 2024, was $41.7 million, not including the direct offering concluded in February 2025 [25] Business Line Data and Key Metrics Changes - The VERSATILE-003 Phase 3 clinical trial of Versamune HPV + pembrolizumab has been initiated, targeting HPV16-positive head and neck cancer, a growing population in need of targeted therapies [8][10] - The trial design includes approximately 350 patients, with a primary endpoint of median overall survival [10][12] - The VERSATILE-002 Phase 2 study showed median overall survival at 30 months, with an objective response rate improvement from 26% to 36% [12][13] Market Data and Key Metrics Changes - HPV-16 positive head and neck cancer is projected to become the most prevalent type of head and neck cancer in the U.S. and Europe by the mid-2030s [9] - The best-published median overall survival for pembrolizumab is 17.9 months, while the disease control rate improved from 70% to 77% in the VERSATILE-002 study [13][14] Company Strategy and Development Direction - The company aims to be the first to market an HPV-targeted immunotherapy for head and neck cancer, leveraging the promising results from the VERSATILE-002 study [16][84] - The company is focusing on progressing the VERSATILE-003 trial while maintaining strong relationships with the National Cancer Institute for other clinical trials [17][56] - Future plans include exploring non-dilutive funding options and potential partnerships to support pipeline development [35][38] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging funding environment but expressed confidence in their ability to raise necessary capital in a stepwise manner as the Phase 3 trial progresses [34][35] - The company is optimistic about the potential for accelerated approval discussions with the FDA based on interim data readouts from the VERSATILE-003 trial [47][49] - Management emphasized the importance of rapid patient enrollment in the trial, aided by the familiarity of sites involved in the previous Phase 2 study [51][53] Other Important Information - The company announced FDA clearance for the Investigational New Drug application for the combination of Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer [16] - The company is also exploring the potential of a triple combination therapy involving IL-12, pending the success of the doublet therapy [61][70] Q&A Session Summary Question: Enrollment trajectory for Versamune-003 and projected timelines - Management indicated that most sites from the Phase 2 trial are re-engaged, which should expedite enrollment [29][30] Question: Current funding environment for studies - Management acknowledged the challenging funding environment but expressed satisfaction with recent fundraising efforts [33][34] Question: Rationale for the reduced patient sample size in VERSATILE-003 - The trial size was reduced from over 400 to 350 patients based on improved confidence in clinical outcomes from the Phase 2 study [44] Question: Timeline for MUC1 candidate and TARP program - The MUC1 trial is led by the National Cancer Institute, and timelines will depend on their progress [75][79]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 increased by 9.9% to $17.9 million, with full-year revenue reaching $76.6 million, up from $74.1 million in 2023 [7][23] - Gross margin for Q4 2024 was 41.2%, compared to 35.1% in Q4 2023, and full-year gross margin improved to 37.9% from 30% in 2023 [23][25] - Fully diluted GAAP EPS for Q4 2024 was $0.93, significantly up from $0.08 in the prior year, while full-year GAAP EPS was $2.35 compared to a loss of $0.65 in 2023 [25][27] Business Line Data and Key Metrics Changes - The BKR 9000 product line showed strong order activity, with a backlog of $21.8 million at year-end, up $5.8 million from the previous year [12] - The shift in product mix towards the BKR 9000 contributed to improved gross margins, with expectations for continued momentum in 2025 [11][14] Market Data and Key Metrics Changes - The federal government is expected to contribute only 35% of revenue in 2025, down from 49% in 2023, indicating a shift towards state and local government markets [17] - Initial customer feedback on recent price increases of 5% to 10% has been supportive, with no observed demand changes [15] Company Strategy and Development Direction - The company aims for single-digit revenue growth in 2025, targeting a gross margin of at least 42% and GAAP diluted EPS exceeding $2.40 [31] - Investments in sales and marketing will be increased to accelerate the adoption of the BKR 9000, alongside R&D investments to enhance software capabilities [32][34] - The rebranding of the SaaS business unit to BK One Solutions aims to address interoperability challenges in public safety communications [34] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertain macroeconomic environment, particularly regarding tariffs, and emphasized the importance of delivering quality products while maintaining profitability [14][17] - The company is optimistic about its growth trajectory and believes it is well-positioned to enhance shareholder value through 2025 and beyond [37] Other Important Information - The company reported a significant improvement in its balance sheet, with cash and cash equivalents of approximately $7.1 million and no debt as of December 31, 2024 [29] - Non-GAAP adjusted EBITDA for the full year 2024 was $10.4 million, a substantial increase from $1.5 million in 2023 [21][27] Q&A Session Summary Question: How has order activity been year to date? - Management indicated that first-quarter order volume is in line with expectations, with federal government funding expected to flow in the second quarter [40][42] Question: Where is the most interest for the BKR 9000? - Interest is primarily in the state and local markets, where the multiband capabilities of the BKR 9000 are particularly attractive [44][46] Question: What is the timeline for the software initiative to become a bigger part of the P&L? - Management is still assessing the market for the software solutions and expects to provide clarity on the potential size of the solutions business by the end of 2025 [48][52] Question: Can margin improvement continue even before the price increase? - Management expects healthy margins in Q1 but anticipates a drop in gross margin in Q2 due to tariffs, with expectations to stabilize in the second half of the year [82][84] Question: Will the software side become a revenue source? - While the software business is currently small, it is expected to grow, particularly with the addition of new products to the portfolio [92][94]

Financial Data and Key Metrics Changes - The company ended 2024 with $231.5 million in cash and marketable securities, expected to support operations into the first half of 2027 [22] - R&D expenses increased to $93.8 million in 2024, primarily due to spending for the ALTITUDE AD trial [23] - The company reported a loss from operations of $114 million and a net loss of $102.3 million for the year [24] Business Line Data and Key Metrics Changes - The ALTITUDE AD Phase 2 study, which evaluates the efficacy and safety of sabirnetug in early Alzheimer's patients, completed enrollment of 542 participants [9][10] - The primary endpoint of the ALTITUDE study is a change from baseline to 18 months on the Integrated Alzheimer's Disease Rating Scale (iADRS) [10] Market Data and Key Metrics Changes - The company noted a growing demand for Alzheimer's treatments, driven by an aging population and improved diagnostic capabilities [19] - The adoption of anti-A-Beta treatments is expected to continue growing, serving as a cornerstone for Alzheimer's treatment [19] Company Strategy and Development Direction - The company is focused on advancing the clinical development of sabirnetug, with a commitment to operational excellence in the ALTITUDE AD trial [17] - There is an emphasis on utilizing fluid biomarkers, such as p-tau 217, to improve patient screening and enrollment efficiency [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of sabirnetug as a next-generation treatment for Alzheimer's, highlighting its improved benefit-risk profile [20] - The company is encouraged by the continued adoption of new Alzheimer's treatments and the potential for next-generation therapies [18] Other Important Information - The Phase 1 study results of sabirnetug were published in the Journal of the Prevention of Alzheimer's Disease [15] - The company has maintained a significant presence at major Alzheimer's conferences to communicate its research findings [14] Q&A Session Summary Question: Interest in preclinical Alzheimer's trials - Management acknowledged the potential to explore preclinical populations but emphasized current focus on the ALTITUDE AD trial [29][31] Question: Biomarkers and clinical study assumptions - Management highlighted the importance of biochemical biomarkers, particularly p-tau 217, in identifying patient responses and improving treatment outcomes [47][49] Question: Use of p-Tau-217 in patient screening - Management confirmed that p-Tau-217 is effective as a screening tool for amyloid positivity, significantly reducing negative PET scans [62] Question: Subcutaneous formulation and efficacy data - Management indicated that the subcutaneous formulation expands patient options and is currently under further development [35][84] Question: Comparison of patient populations in trials - Management noted that the patient population for ALTITUDE AD appears similar to that of previous studies, without specific tau requirements [87] Question: Positioning of sabirnetug in the market - Management expressed confidence that sabirnetug will be a differentiated treatment option as the ALTITUDE AD trial approaches completion [92]

Financial Data and Key Metrics Changes - FGI reported total revenue of $35.6 million in the fourth quarter, representing a year-over-year increase of 15% [8][16] - Gross profit was $8.7 million, a decrease of 3.2% compared to the prior year, with gross margin declining to 24.6% from 29.2%, a drop of 460 basis points [8][16] - Operating expenses increased by 28.4% to $10 million from $7.8 million in the prior year, leading to a GAAP operating income of negative $1.3 million, down from a positive $1.2 million in the prior year [17] Business Line Data and Key Metrics Changes - Bath Furniture revenue increased by 40.2% year over year, driven by market-aligned pricing and new business wins [10] - Shower Systems business reported a revenue increase of 17%, supported by new customer programs and order growth [11] - Covered Bridge revenue in custom kitchen cabinetry increased by 68.3% due to order momentum and expanded geographies [11] Market Data and Key Metrics Changes - Revenue growth in the US, Canada, and Europe markets was 14.7%, 9.9%, and 23.3% respectively [10] - Sanofi revenue increased by 5.8% year over year in the fourth quarter [10] - The overall industry outlook remains relatively flat, with customers forecasting minimal growth in 2025 [9] Company Strategy and Development Direction - The company is focused on organic growth initiatives across its brands, products, and channels, referred to as the BPC strategy [7] - Geographic expansion in Europe and India is seen as a significant growth driver for upcoming quarters [12] - The company is actively working to diversify sourcing in response to the increasing tariff environment [13][25] Management's Comments on Operating Environment and Future Outlook - Management expects the industry to remain flat but is confident in the company's ability to outpace the market through new programs and initiatives [27][50] - The company is cautious about tariff pressures impacting business and has adjusted its guidance accordingly [36][50] - Management believes that new business wins and market growth will buffer against a flat market outlook [50] Other Important Information - The company has a total liquidity of $15.6 million, which is deemed sufficient to fund growth initiatives [18] - Initial guidance for 2025 includes revenue expectations of $135 to $145 million, with adjusted operating income guidance ranging from negative $2 million to positive $1.5 million [18] Q&A Session Summary Question: Impact of tariffs on the business - Management is working closely with suppliers and customers to mitigate tariff impacts and is diversifying sourcing to navigate the situation [22][24][25] Question: Outlook for operating income - The guidance includes tariff pressure, and management is being conservative in their outlook while optimistic about new growth initiatives [33][36] Question: Pricing strategies in a volatile tariff environment - The company adjusts pricing as necessary and works closely with customers to manage the impact of tariffs [39][41] Question: Sourcing adjustments due to tariffs - The company has been active in diversifying sourcing to mitigate tariff impacts, with ongoing adjustments being made [44][45] Question: Risks versus upside in the R&R market - The overall R&R market outlook remains flat, but new programs and business wins are expected to help the company outpace the market [49][50]

Financial Data and Key Metrics Changes - The company reported a sequential increase in profitability, attributed to operational pricing and cost improvements within the Towable and Motorhome RV segments [11] - Gross margin declined year over year due to a shift in product mix, but improved by 110 basis points sequentially due to lower allowances and discounts [35][36] - Adjusted EBITDA increased by 140 basis points sequentially, driven by lower allowances and discounts alongside reduced SG&A expenses [36] Business Line Data and Key Metrics Changes - In the Towable RV segment, revenues increased modestly year over year due to higher unit volume, but adjusted EBITDA margin declined due to product mix shifts and higher input costs [37] - Motorhome RV revenues decreased year over year, reflecting lower unit sales due to market conditions, although the launch of the Grand Design Motorhome Lineage lineup provided some offset [38] - Marine segment revenues increased year over year primarily due to unit volume, with adjusted EBITDA rising due to targeted price increases and operational efficiencies [40] Market Data and Key Metrics Changes - The company forecasts wholesale RV shipments for calendar 2025 to be between 320,000 to 350,000 units, approximately 4% below the RVIA's forecast, reflecting a conservative approach amid subdued retail conditions [25] - The company noted that retail patterns in March mirrored those of February, indicating no significant change in consumer sentiment [69] - Market share in motorhomes rose mid-single digits in 2024 versus 2023, while towable market share grew low single digits over the same period [28][29] Company Strategy and Development Direction - The company is focused on disciplined production, strong dealer relationships, improved operating efficiency, and sustained innovation to position itself for sustainable growth [11][12] - A tri-brand strategy in the motorhome sector aims to cater to distinct market segments and mitigate risks while unlocking potential for margin expansion [20] - The Winnebago Towables business is undergoing a strategic transformation to reset its portfolio with a new pricing strategy and product offerings [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed caution regarding the economic environment, noting that inflation and consumer confidence are critical factors affecting future sales [46][47] - The adjusted EPS guidance was reduced to a range of $2.75 to $3.75 per diluted share, reflecting a decrease in consumer confidence and sentiment [48] - Despite challenges, management remains optimistic about new products and long-term strategies, emphasizing a commitment to profitability and market presence [49][53] Other Important Information - The company completed a $100 million cash tender offer to repurchase a portion of its senior secured notes due 2028 [41] - A quarterly dividend of $0.34 per share will be paid in April, marking the forty-third consecutive quarterly dividend [43] - The company is actively managing tariff impacts through strategic sourcing and supplier collaboration [44] Q&A Session Summary Question: Impact of tariffs on EPS guidance - Management indicated that the guidance incorporates expected tariff impacts, which are believed to be relatively limited for fiscal 2025 [58] Question: Retail trends in March - Management noted that retail patterns in March were consistent with February, with no significant changes observed [69] Question: Inventory management and dealer relationships - Management emphasized the importance of maintaining healthy dealer relationships and managing inventory levels effectively [72] Question: Pricing strategy for Winnebago Towables - The company is adjusting pricing to enhance retail effectiveness and improve dealer inventory turnover [108] Question: Future product offerings and market share - Management expressed confidence in the potential for market share growth through new product introductions and improved dealer relationships [117]