Haemonetics (HAE) Q4 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Olga Guyette - VP - Investor Relations & TreasurerChristopher Simon - CEO, President & DirectorJames D'Arecca - Executive VP & CFORohin Patel - Vice PresidentMarie Thibault - Managing DirectorAndrew Cooper - VP - Equity ResearchJoanne Wuensch. - Managing DirectorAnthony Petrone - Managing Director Conference Call Participants Mike Matson - Senior Equity Research AnalystMike Petusky - Research AnalystCraig Bijou - Equity Re ...

Financial Data and Key Metrics Changes - The company ended the first quarter with a cash position of $204.1 million, which includes approximately $65.5 million in net proceeds from a public offering closed in January 2025 [23] - Total operating expenses for the quarter were $37.8 million, down 82% from the same period in 2024 [25] - Research and development expenses were $22.1 million compared to $36.6 million in Q1 2024, primarily due to decreased spending on AMX-thirty five and reduced payroll costs [25] - Selling, general and administrative expenses were $15.7 million compared to $57.8 million in Q1 2024, mainly due to decreased payroll and consulting costs [25] Business Line Data and Key Metrics Changes - The company is advancing three potential therapies across four clinical trials, including Avexatide for post bariatric hypoglycemia (PBH), AMX-thirty five for Wolfram syndrome and progressive supranuclear palsy (PSP), and AMX-one hundred fourteen for ALS [7][8] - Avexatide has shown promise in treating PBH, with a pivotal Phase III trial (Lucidity) initiated, and the first participant dosed [10][18] - AMX-thirty five is being evaluated in two indications, with positive Phase II data reported for Wolfram syndrome and ongoing trials for PSP [12][14] Market Data and Key Metrics Changes - There are approximately 160,000 people in the U.S. living with PBH, a condition with no approved treatment options [9][19] - The American Society for Metabolic and Bariatric Surgery reported around 270,000 new bariatric surgeries in 2023, indicating a stable market for potential PBH patients [20] - The company estimates that 8% of patients who undergo bariatric surgery will develop PBH within one to three years [48][50] Company Strategy and Development Direction - The company aims to develop novel therapies for diseases with high unmet needs, focusing on execution across its clinical trials [28] - The company is preparing for a potential commercial launch of Avexatide in 2027 if approved [10] - The company is actively engaging with clinical trial sites and expects to complete recruitment for the Lucidity trial by the end of 2025 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving clinical milestones through the end of 2026, supported by a strong cash position [23][24] - The company is focused on educating the medical community and patients about PBH, given the lack of awareness and treatment options [34][46] - Management highlighted the importance of access to treatments for patients suffering from debilitating conditions like PBH [65] Other Important Information - The company plans to present week 48 data from the HELIOS trial in Wolfram syndrome at an upcoming conference [12][28] - The company is preparing for potential FDA discussions regarding trial designs for its various programs [56] Q&A Session Summary Question: Will a large patient education campaign be required for Avexatide? - Management acknowledged the need for education due to the rarity of PBH and the lack of prior treatments, emphasizing the importance of informing both medical professionals and patients [32][34] Question: What is the expected efficacy for the PSP trial? - Management stated the study has 80% power to detect a 30% effect on the PSP rating scale, with multiple endpoints being considered for decision-making [37][39] Question: How many of the 160,000 PBH patients are seeking treatment? - Management indicated that a larger group, potentially up to 1 million, may experience hypoglycemia post-bariatric surgery, but only about 160,000 have persistent symptoms warranting treatment [46][47] Question: What are the remaining questions with the FDA regarding trial design? - Management noted that the week 48 data will inform the Phase III program, but specific details of FDA discussions were not disclosed [56] Question: Will there be subgroup analysis in the Avexatide study? - Management confirmed that the study will focus on a population experiencing frequent hypoglycemic events, with no anticipated step therapy restrictions [61][62] Question: What gives confidence that Avexatide won't cause safety issues? - Management highlighted the good safety profile observed in both non-clinical and clinical data, noting that Avexatide is a competitive antagonist rather than a GLP-1 agonist [70] Question: How does Avexatide compare to other drugs in the space? - Management emphasized Avexatide's strong profile and breakthrough therapy designation, noting that other programs are earlier in development and face hurdles [82][84]

Financial Data and Key Metrics Changes - Acacia recorded total revenue of $124.4 million during the first quarter, a significant increase compared to the previous year [21] - The company reported first quarter GAAP operating income of $38.3 million, compared to a GAAP operating loss of $2.1 million in the same quarter last year [24] - GAAP net income attributable to Acacia was $24.3 million or $0.25 per share, compared to a net loss of $200,000 or $0 per share in the prior year period [25] Business Line Data and Key Metrics Changes - Energy operations generated $18.3 million in revenue for the quarter, compared to $1.9 million in the same quarter last year [21] - Manufacturing operations generated $28.5 million in revenue, while industrial operations generated $7.7 million, a slight decrease from $8.8 million in the same quarter last year [22] - Intellectual property operations generated $69.9 million in licensing and other revenue, compared to $13.6 million in the same quarter last year, primarily due to a large settlement [23] Market Data and Key Metrics Changes - The company has hedged over 70% of its production through the end of 2027, providing price protection and greater cash flow predictability [11] - Approximately 51% of Benchmark's last twelve months revenue and 78% of production was driven by gas and natural gas liquids, which have remained resilient despite recent market volatility [11] Company Strategy and Development Direction - Acacia's strategy focuses on acquiring and building businesses with stable long-term cash flow generation and scalability [6] - The company is actively exploring strategic acquisitions and organic growth initiatives across its verticals, particularly in energy and industrial sectors [28] - Management is evaluating opportunities in the mature technology sector, aiming to enhance the value of its intellectual property portfolio [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Acacia's resilience amid macroeconomic uncertainties and believes the current environment presents compelling opportunities [28] - The company is optimistic about the long-term growth potential of its Deflecto business and is implementing initiatives to optimize operations [15] - Management highlighted the importance of disciplined cost management and operational excellence in navigating volatile market conditions [16] Other Important Information - Total consolidated G&A expense was $17.3 million during the first quarter, an increase from $12.5 million in the same quarter last year, primarily due to the addition of Deflecto [23] - Cash, cash equivalents, and equity securities at fair value totaled $290 million as of March 31, 2025, compared to $297 million at December 31, 2024 [26] Q&A Session Summary Question: Can you detail the total winnings from the WiFi portfolio? - Management indicated that since Q1 2023, approximately $178 million has been generated from the WiFi assets, with more value expected in the portfolio [33] Question: Are you seeing prices coming down in M&A? - Management confirmed they are looking at opportunities in energy, industrials, and mature technology, with a focus on assets that can be improved through operational efficiencies [35][36] Question: What is the calculus on protecting tax attributes versus share buybacks? - Management completed a $20 million buyback and is monitoring tax attributes to determine the optimal time for further buybacks [41] Question: Will the recent settlement pressure the defendant in the $37 million judgment case to settle sooner? - Management expressed hope that the recent settlement would encourage a quicker resolution, but could not provide a definitive answer [50]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with 31.2 million total members, a 42.3% year-over-year increase [16] - Total bookings reached $207 million, reflecting a 14.8% growth [17] - Free cash flow was $91 million, representing a 17.6% increase year-over-year [21] - Operating income was $37 million, with a 17.7% operating margin [20] - Adjusted EBITDA was $52 million, corresponding to a 24.7% adjusted EBITDA margin [20] Business Line Data and Key Metrics Changes - Active Clear Plus members grew to 7.4 million, a 9.1% increase [17] - Gross dollar retention was 87.1%, down 140 basis points sequentially due to previous price increases [18] - The company operates approximately 15% of total TSA PreCheck enrollment locations, with 165 locations currently active [19] Market Data and Key Metrics Changes - U.S. air travel demand increased, with TSA checkpoint volumes growing almost 1% [6] - Clear is active in 59 Clear Plus airports and four domestic Clear mobile airports, reaching 74% of U.S. airline passengers [5] Company Strategy and Development Direction - Clear is focused on enhancing member experience and expanding its network and product offerings [4] - The introduction of new products like ePassport and NV Pods aims to improve enrollment and verification processes [10][9] - The company is preparing for major global events like the World Cup in 2026 and the Olympics in 2028, positioning itself for increased visibility and demand [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's resilience despite macroeconomic uncertainties, noting healthy gross adds and conversion rates [27] - The company is optimistic about its growth trajectory, particularly in the TSA PreCheck segment and overall member acquisition [19][23] - Management highlighted the importance of public-private partnerships in navigating regulatory challenges and enhancing member experience [23] Other Important Information - The company ended the quarter with $533 million in cash and marketable securities after returning $168 million to shareholders [22] - The federal REAL ID enforcement date has heightened the importance of Clear's services, with a focus on ensuring members are REAL ID ready [13] Q&A Session Summary Question: Can you discuss the macro factors considered for Q2 bookings guidance? - Management noted that gross adds and conversion rates remain healthy, with no observed softness in business due to macro sentiment [27][30] Question: What is happening with family member retention post-price increases? - Management indicated that overall member retention trends remain consistent, with improvements in net adds compared to the previous year [32][33] Question: How will the company express flexibility around long-term investments in a downturn? - Management emphasized the focus on automation and operating leverage as key opportunities for growth, while maintaining flexibility in capital allocation [35][39] Question: What are the dynamics of the partnership with American Express? - Management highlighted the importance of credit card partnerships in member acquisition and the alignment of interests between Clear and its partners [53][55] Question: Can you elaborate on the progress in the B2B business, particularly in Healthcare and Financial sectors? - Management noted significant partnerships in healthcare and the importance of platform integration for both workforce and patient solutions [58][60]

Financial Data and Key Metrics Changes - Sales increased by 3% to $351 million, in line with expectations, driven by strong growth in coolers and equipment and continued momentum in international business [35][36] - Gross profit rose by 3% to $201.3 million, representing 57.3% of sales, a 20 basis point decrease year-over-year [42] - Net income decreased by 12% to $25.8 million, or $0.31 per diluted share, reflecting a decrease of 9% compared to the prior year [45][60] Business Line Data and Key Metrics Changes - Coolers and Equipment sales increased by 17% to $140.2 million, marking the fifth consecutive quarter of double-digit growth [36] - Drinkware sales decreased by 4% to $205.6 million, impacted by a challenging market and supply chain disruptions [37][38] - Direct-to-consumer sales grew by 4% to $196.2 million, representing 56% of total sales [39] Market Data and Key Metrics Changes - International sales grew by 22% to $79.9 million, despite a 500 basis point headwind from foreign exchange [41] - Strong performance noted in Europe, particularly in Germany, The Netherlands, and The U.K., with significant growth opportunities identified [29][30] Company Strategy and Development Direction - The company is focused on three key areas: accelerating product innovation, transforming the supply chain, and maintaining operational discipline [5][8] - Plans to introduce over 30 new products in 2025, up from 24 in 2024, despite supply chain constraints [9][67] - Supply chain transformation aims to reduce reliance on China, with expectations that less than 5% of total COGS will be related to products from China by the end of the year [12][63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating 2025 despite macroeconomic uncertainties and projected headwinds from tariffs and cautious consumer behavior [7][8] - The company anticipates a challenging second quarter with flat to slightly down sales year-over-year, particularly in U.S. Drinkware [51] - Long-term growth potential remains strong, with a focus on international expansion and product innovation [55][93] Other Important Information - The company ended the first quarter with $259 million in cash and a substantial net cash position [46] - Capital expenditures are expected to be approximately $60 million, with a focus on supply chain diversification efforts [60] Q&A Session Summary Question: Number of new product introductions expected for 2025 - The company expects about 30 new products in 2025, compared to 24 in 2024, with a focus on maintaining innovation despite supply chain disruptions [67][68] Question: Impact of tariffs and supply chain changes - Approximately 90% of the $100 million tariff impact is attributed to China, with expectations of a much stronger position by the end of the year as supply chain diversification progresses [73][75] Question: Outlook for the Drinkware business - The company anticipates durable demand in the Drinkware category, with ongoing innovation and a diversified product portfolio to address various consumer needs [79][80] Question: Approach to pricing amid rising costs - The company is focused on targeted pricing strategies while shifting supply chains, aiming for a stable pricing environment that supports long-term growth [89][90] Question: Acceleration of international growth - The company sees significant growth opportunities in established international markets and plans to leverage the launch in Japan to expand further into Asia [91][93]

Intellia Therapeutics (NTLA) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Brittany Chaves - Senior Manager, Investor RelationsJohn Leonard - President and Chief Executive OfficerDavid Lebwohl - EVP & Chief Medical OfficerEdward Dulac - EVP & CFOLili Nsongo - VP - Equity Research, BiotechnologyTroy Langford - Biotechnology Equity Research Vice President Conference Call Participants Gena Wang - AnalystNone - AnalystKostas Biliouris - Director - Biotech Equity AnalystLuca Issi - Senior B ...

AxoGen (AXGN) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Michael Dale - President, CEO & Board DirectorNir Naor - Chief Financial OfficerJens Schroeder Kemp - Chief Marketing OfficerCaitlin Cronin - DirectorChris Pasquale - Partner - Medical Devices & SuppliesBrett Gasaway - VP - Equity ResearchMatthew Park - Equity Research AssociateRick Ditto - VP, Global Health Economics, Reimbursement & PolicyJayson Bedford - Managing Director - Medical Technology Conference Call Participants Mi ...

Financial Data and Key Metrics Changes - The company ended the first quarter with a cash position of $204.1 million, which includes approximately $65.5 million in net proceeds from a public offering closed in January 2025 [23] - Total operating expenses for the quarter were $37.8 million, down 82% from the same period in 2024 [25] - Research and development expenses were $22.1 million compared to $36.6 million in Q1 2024, primarily due to decreased spending on AMX-thirty five and reductions in payroll and personnel costs [25] - Selling, general and administrative expenses were $15.7 million compared to $57.8 million in Q1 2024, mainly due to decreased payroll and consulting costs [25] Business Line Data and Key Metrics Changes - The company is advancing three potential therapies across four clinical trials, including Avexatide for post-bariatric hypoglycemia (PBH), AMX-thirty five for Wolfram syndrome and progressive supranuclear palsy (PSP), and AMX-one hundred fourteen for ALS [7][8] - Avexatide has shown promise in treating PBH, with a pivotal Phase III trial (Lucidity) initiated, and the first participant dosed [10][18] - AMX-thirty five is being evaluated in two indications, with positive Phase II data reported for Wolfram syndrome and ongoing trials for PSP [12][14] Market Data and Key Metrics Changes - There are approximately 160,000 people in the U.S. living with PBH, a condition with no approved treatment options [9][19] - The American Society for Metabolic and Bariatric Surgery reported approximately 270,000 new bariatric surgery procedures in 2023, indicating a stable market for potential PBH patients [20] Company Strategy and Development Direction - The company aims to execute across its clinical programs, focusing on diseases with high unmet needs [28] - The anticipated commercial launch of Avexatide is planned for 2027, contingent on successful trial outcomes [10] - The company is preparing for potential market entry and is focused on educating healthcare providers and patients about PBH [34][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving clinical milestones through the end of 2026, supported by a strong cash position [23][29] - The company is optimistic about the potential of its therapies, particularly Avexatide, given the high unmet need in PBH [84] - Management highlighted the importance of education and access for patients suffering from PBH, emphasizing the need for awareness in the medical community [34][66] Other Important Information - The company plans to present week 48 data from the HELIOS trial in Wolfram syndrome and expects to share unblinded Phase 2b data from the ORION trial in PSP in the third quarter [28] - The company is also preparing for early cohort data from the Phase I LUMINA trial of AMX-one hundred fourteen in ALS by the end of the year [28] Q&A Session Summary Question: Will a large patient education campaign be required for Avexatide in PBH? - Management acknowledged the need for education due to the rarity of treatments for PBH and the importance of informing both medical professionals and patients about the condition and potential treatment options [31][34] Question: What is the expected efficacy bogey on the PSP rating scale? - Management indicated that the study has 80% power to detect a 30% effect on the PSP rating scale, with multiple endpoints being considered for decision-making [35][37] Question: How many of the 160,000 PBH patients are seeking treatment? - Management clarified that while 160,000 represent those with persistent hypoglycemia, a larger group of 500,000 to 1 million may experience hypoglycemia post-bariatric surgery [44][46] Question: What are the remaining questions with the FDA on trial design? - Management stated that the week 48 data will inform the Phase III program, but specific details of discussions with the FDA were not disclosed [53][56] Question: Will there be subgroup analysis within the Avexatide study? - Management confirmed that the study is focused on a population experiencing frequent hypoglycemic events, and they do not anticipate step therapy restrictions due to the lack of approved therapies for PBH [61][62] Question: What gives confidence that GLP-one antagonists like Avexatide won't cause safety issues? - Management highlighted the good safety profile observed in both non-clinical and clinical data for Avexatide, noting that it is a competitive antagonist rather than a full agonist [69][71] Question: How does the company compare Avexatide to other drugs in the space? - Management emphasized that Avexatide is in Phase III with breakthrough therapy designation, and they believe it has a strong profile compared to earlier-stage programs [82][84]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $42.7 million, representing a 72% year-over-year increase, with constant currency growth at 76% [8] - Gross profit reached $24.2 million, reflecting a gross margin of approximately 57%, a decline of 14 percentage points from the previous year [9] - Net loss was $300,000 or $0.00 per share, a decline of $4.2 million from the previous year [12] - Adjusted EBITDA declined by $300,000 or 5% to $5.6 million [12] - Cash and cash equivalents as of March 31, 2025, were $29.7 million, with a net debt leverage ratio under 1.6 turns [13] Business Line Data and Key Metrics Changes - The raffle business achieved record results, including all-time highs in revenue, ticket sales, and prize values, with a 46% increase in new users compared to Q1 2024 [6] - MeridianBet saw new registrations increase by 22%, first-time deposits surged over 56%, and total deposits rose 12% [15] Market Data and Key Metrics Changes - MeridianBet secured a permanent online betting license in Brazil, allowing full national coverage in a market projected to generate over $5.6 billion in GGR in 2025 [16] - The company launched B2B operations in Nigeria, tapping into a market with over 60 million bettors [16] Company Strategy and Development Direction - The company is focused on platform innovations and expansion into high-growth regulated markets, positioning itself at the forefront of the iGaming industry [5] - The strategy emphasizes smart growth, operational efficiency, and returning value to shareholders [20] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about growth opportunities for the year, expecting full-year revenue between $190 million and $195 million, representing a 26% to 29% growth rate over 2024 [21] - The company remains committed to disciplined capital allocation and investments that enhance growth and long-term value [21] Other Important Information - The company eliminated approximately $9.6 million in debt and converted over $9.5 million in acquisition-related debt into equity, enhancing financial strength and flexibility [6] - MeridianBet's community initiatives included 56 projects focused on health donations, scholarships, and responsible betting education [17] Q&A Session Summary Question: What are the growth expectations for the company in 2025? - The company expects full-year revenue to be between $190 million and $195 million, indicating a growth rate of 26% to 29% over 2024 [21] Question: How is the company addressing operational costs? - The increase in operating expenses is attributed to costs related to geographic expansion, market share improvement, and technology advancements [11]

Veru (VERU) Q2 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Samuel Fisch - Executive Director of Investor Relations & Corporate CommunicationsMitchell Steiner - Chairman, President & CEOMichele Greco - CFO & Chief Administrative OfficerAnthea Li - Equity Research AssociateGary Nachman - Managing Director - Equity ResearchGary Barnette - Chief Scientific OfficerEduardo Martinez-Montes - Biotechnology Equity Research Associate Conference Call Participants William Wood - Equity Research Ana ...