Destination XL Group, Inc. (NASDAQ:DXLG) Q4 2024 Earnings Conference Call March 20, 2025 9:00 AM ET Company Participants Shelly Mokas - Vice President of Financial Reporting & SEC Compliance Harvey Kanter - President & Chief Executive Officer Peter Stratton - Chief Financial Officer Conference Call Participants Michael Baker - D.A. Davidson Jeremy Hamblin - Craig-Hallum Operator Good day, everyone, and welcome to the Destination XL Group, Inc. Fourth Quarter Fiscal 2024 Financial Results Conference Call. To ...

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had cash, cash equivalents, short-term investments, and restricted cash of $98.1 million, compared to $52.6 million as of December 31, 2023, indicating a significant increase in financial resources [37] - Research and development expenses for the full year ended December 31, 2024, were $34.4 million, up from $31.1 million in 2023 [39] - General and administrative expenses rose to $29.9 million for the full year ended December 31, 2024, compared to $19 million in 2023, primarily due to commercial launch preparation costs [39] - The net loss for the full year ended December 31, 2024, was $63.7 million, or $1.55 loss per common share, compared to a net loss of $54.2 million, or $2.53 loss per common share in 2023 [40] Business Line Data and Key Metrics Changes - The company is preparing for the potential launch of pz-cel for recessive dystrophic epidermolysis bullosa (RDEB), with expectations to activate treatment centers and begin patient biopsies in the third quarter of 2025, pending FDA approval [10][12] - The estimated market opportunity in the U.S. for pz-cel includes approximately 1,500 treatment opportunities, with a cumulative revenue potential of over $2 billion [16] Market Data and Key Metrics Changes - The company estimates that approximately 750 RDEB patients in the U.S. with moderate to severe wounds are potential candidates for pz-cel treatment [16] - The payer mix for RDEB treatment shows that 60% to 65% of lives are covered by commercial plans, 30% to 35% by Medicaid, and less than 10% by Medicare [27] Company Strategy and Development Direction - The company aims to launch pz-cel in the U.S. and is focused on ensuring favorable access policies and reimbursement for treatment centers [26] - Plans include ramping up manufacturing capacity to support 200-plus annual pz-cel treatments by the second half of 2027 [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date for pz-cel and the potential to transform the treatment paradigm for RDEB patients [12] - The company anticipates a gradual ramp-up in treatment center activity post-launch, with initial treatment of one to two patients as centers become accustomed to the pz-cel treatment process [24] Other Important Information - The company has received a priority review designation from the FDA for pz-cel, with a PDUFA action date of April 29, 2025 [7][14] - The company is also in discussions with Ultragenyx regarding a partnered program for Sanfilippo syndrome type A, with a BLA submitted to the FDA and a PDUFA date of August 18, 2025 [13] Q&A Session Summary Question: FDA satisfaction with CMC work - Management believes they have addressed all FDA requests from the previous CRL and feel confident about the current review process [44][45] Question: Patient eligibility at treatment centers - Management indicated that approximately 30% of the 750 RDEB patients are located in seven centers of excellence, with discussions ongoing to identify eligible patients [51] Question: Key reasons for seeking pz-cel therapy - The primary driver for patients is the need for durable wound closure, which can minimize infections and improve quality of life [55] Question: Draft label alignment with expectations - Management confirmed that the draft label received from the FDA aligns with their expectations, with no major surprises anticipated [63] Question: Anticipation of patient backlog post-approval - Management expects a patient backlog initially as manufacturing capacity ramps up, with a queue of patients anticipated [64] Question: Physician education needs - There is a need for physician education, particularly for community physicians who have not been engaged until approval is secured [71] Question: PRV expectations and recent trends - Management does not anticipate any factors that would preclude the granting of a PRV and aims to optimize pricing for any potential sale [82][85] Question: Market deployment outside the U.S. - Interest exists from European and Asian markets, but discussions will be more meaningful post-U.S. approval [89] Question: Total number of treatment centers planned - The company does not anticipate exceeding 10 treatment centers, focusing on building experience at each center [99]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $759.9 million, a 12% decrease from $852.1 million in the prior year period [24] - Gross profit for Q4 2025 was $51 million, down from $141 million in the prior year, with a gross profit margin of 6.7% [24][25] - Adjusted net loss for Q4 2025 was $44.9 million or $1.98 per diluted share, compared to a net income of $24 million or $1.05 per diluted share in the prior year [27][33] Business Line Data and Key Metrics Changes - Agriculture segment sales decreased by 13.8% to $534.7 million, with same-store sales declining by 15.5% [28] - Construction segment same-store sales decreased by 5.5% to $94.6 million, maintaining an equipment margin above 10% [29] - European segment sales increased by 6.1% to $65.4 million, with a same-store sales increase of 5.7% [30] - Australia segment sales were $65.3 million, down from $69.8 million, with a same-store sales decrease of 6.5% [31] Market Data and Key Metrics Changes - North American large ag equipment demand is expected to decline by approximately 30% in calendar 2025 [14] - European operations faced challenges due to lower commodity prices and high interest rates, with expectations for modest revenue growth in FY 2026 [16] - Australian market dynamics are similar to the domestic ag segment, with expected revenue down by 15% to 20% [42] Company Strategy and Development Direction - The company is focusing on inventory optimization and transitioning from general inventory reduction to optimizing inventory mix [11][12] - Emphasis on enhancing service business and customer care strategy to drive growth [12][22] - The company aims to strengthen its foundation through improved inventory management and corporate controls [20][22] Management's Comments on Operating Environment and Future Outlook - Management expects continued market headwinds in the near term but believes improvements made will position the company to navigate the current cycle [22] - The outlook for fiscal 2026 includes expectations of revenue declines across segments, particularly in agriculture and construction [37][40] - Management is monitoring government assistance programs and their potential impact on demand [62] Other Important Information - The company achieved a significant inventory reduction of $304 million in Q4, totaling $419 million since inventory peaked [10][35] - Adjusted debt to tangible net worth ratio was 1.8 times, well below the bank covenant of 3.5 times [35] Q&A Session Summary Question: Service margin performance - Management expects service margin to improve year-over-year due to efficiencies from the new ERP system [54] Question: Inventory reduction methods - Most inventory reduction was achieved through the company's dealer network, with minimal reliance on auctions [57][59] Question: Impact of tariffs on business - Management is closely monitoring tariffs and their potential impact on demand, especially in relation to government assistance programs [62] Question: Government assistance and demand behavior - Management believes the current government assistance could positively influence demand, but commodity prices remain the primary driver for equipment purchases [71][73] Question: Optimal inventory levels - Management is targeting a further $100 million reduction in inventory, with flexibility to adjust based on demand [78][106] Question: SG&A guidance for fiscal 2026 - SG&A expenses are expected to decrease to about $380 million, approximately 17.3% of sales [92][94]

ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Q4 2024 Earnings Conference Call March 20, 2025 8:30 AM ET Company Participants Justin Chakma - Chief Business Officer Richard Lowenthal - Co-Founder, President and CEO Eric Karas - Chief Commercial Office Kathleen Scott - CFO Conference Call Participants Ryan Deschner - Raymond James Alexa Deemer - Cantor Fitzgerald Louise Chen - Scotia Bank Roanna Ruiz - Leerink Partners Lachlan Hanbury-Brown - William Blair Julian Harrison - BTIG Justin Chakma - Chief Business Offi ...

NeueHealth (NEUE) Q4 2024 Earnings Call March 20, 2025 01:16 PM ET Company Participants Emily Lombardi - AVP - Enterprise StrategyMike Mikan - President & CEOJay Matushak - Chief Financial Officer Operator Good morning and thank you for joining us for the NUHealth Q4 twenty twenty four Earnings Conference Call. My name is Carly and I'll be coordinating the call today. I'd like to hand over to your host, Emily Lombardi. The floor is yours. Emily Lombardi Good morning, and welcome to NU Health's fourth quarte ...

ZEEKR Intelligent Technology Holding Limited (NYSE:ZK) Q4 2024 Results Conference Call March 20, 2025 8:00 AM ET Company Participants Yuan Jing - Chief Financial Officer Conghui An - Chief Executive Officer Conference Call Participants Tina Hou - Goldman Sachs Tim Hsiao - Morgan Stanley Ming-Hsun Lee - Bank of America Tingwen Yang - CICC Bin Wang - Deutsche Bank Eugene Hsiao - Macquarie Capital Paul Gong - UBS Operator Hello, ladies and gentlemen. Thank you for standing by for ZEEKR Group's Fourth Quarter a ...

Lands' End, Inc. (NASDAQ:LE) Q4 2024 Earnings Conference Call March 20, 2025 8:30 AM ET Company Participants Tom Altholz - Senior Director of Financial Planning and Analysis Andrew McLean - Chief Executive Officer Bernard McCracken - Chief Financial Officer Conference Call Participants Dana Telsey - Telsey Group Marni Shapiro - The Retail Tracker Eric Beder - SCC Research Alex Fuhrman - Craig-Hallum Capital Group Operator Good day, everyone, and welcome to today's Lands' End 4Q Fiscal Year 2024 End Earnings ...

Darden Restaurants, Inc. (NYSE:DRI) Q3 2025 Earnings Conference Call March 20, 2025 8:30 AM ET Company Participants Courtney Aquilla - Senior Director, Finance and Investor Relations Rick Cardenas - President and Chief Executive Officer Raj Vennam - Chief Financial Officer Conference Call Participants Jon Tower - Citi David Palmer - Evercore ISI Eric Gonzalez - KeyBanc Capital Markets Brian Bittner - Oppenheimer Sara Senatore - Bank of America Brian Harbour - Morgan Stanley Dennis Geiger - UBS David Taranti ...

Brian Kinstlinger - Alliance Global Partners Kingsley Crane - Canaccord Genuity Alarum Technologies Ltd (NASDAQ:ALAR) Q4 2024 Results Conference Call March 20, 2025 8:30 AM ET Company Participants Shachar Daniel - Chief Executive Officer Shai Avnit - Chief Financial Officer Conference Call Participants Operator Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Alarum Technologies Fourth Quarter and Full Year 2024 Corporate Update Conference Call. [Operator Instructions] This conferen ...

Financial Data and Key Metrics Changes - The company reported Q4 product revenue of $1.2 million from TECELRA, with expectations to invoice 3 to 4 times as many patients in Q1 2025 compared to the previous quarter [9][10][17] - The consensus analyst forecast for 2025 sales is approximately $25 million, which the company believes is achievable [17][30] Business Line Data and Key Metrics Changes - The launch of TECELRA has seen significant momentum, with 20 authorized treatment centers (ATCs) established, ahead of the planned 30 by the end of 2026 [6][8] - The company has a pipeline of around 20 biomarker-positive patients expected to be treated in Q2 and Q3 2025, with over 80 patients having completed MAGE-A4 testing [11][12] Market Data and Key Metrics Changes - Over 70% of commercial and Medicare lives have established reimbursement policies for TECELRA, with no denials reported to date [12] - The company anticipates that Lete-cel will expand the sarcoma franchise, potentially doubling the number of treatable patients in the US each year [25] Company Strategy and Development Direction - The company aims to build a successful business with two FDA-approved products in sarcoma and achieve cash flow breakeven by 2027 [26][30] - The company is exploring strategic options, including partnerships and collaborations, to optimize shareholder value and ensure financial stability [28][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the acceleration of TECELRA sales and the successful launch of Lete-cel, which is expected to be on the market by 2027 [17][18] - The company is focused on managing costs effectively while pushing towards profitability in 2027, with a significant reduction in cash flow demands due to paused preclinical programs [27][68] Other Important Information - The company has engaged TD Cowen to explore strategic options and financial opportunities [28] - The manufacturing process for TECELRA has exceeded expectations, with 100% of released products manufactured to specification and no capacity bottlenecks reported [14][16] Q&A Session Summary Question: Can you comment on the pace of apheresis during Q1? - The pace of apheresis has been increasing, with more patients being treated as additional ATCs come online [35] Question: What proportion of double positive patients have undergone apheresis? - The majority of double positive patients have started the treatment journey, with some expected to drop out for various reasons [40] Question: What are the assumptions for achieving profitability in 2027? - The company plans to reduce spending significantly and anticipates sales from TECELRA and Lete-cel to contribute to profitability [47][50] Question: Are there any updates on ex-US strategies? - The company is focused on establishing a viable business in the US first, while exploring opportunities for international expansion [66] Question: What is the status of PRAME and CD70 programs? - Both programs are of interest to various pharma companies, and the company is exploring monetization opportunities [82]