Xtant Medical (XTNT) Q2 2025 Earnings Call August 12, 2025 08:30 AM ET Speaker0Good morning, everyone, and welcome to the Xtant Medical Second Quarter twenty twenty five Financial Results. Please note this conference is being recorded. I will now turn the conference over to your host, Kevin Gardner of LifeSci Advisors. The floor is yours.Speaker1Thank you, operator, and welcome to Xtant Medical's second quarter twenty twenty five financial results call. Joining me today are Sean Brown, President and Chief E ...

Financial Data and Key Metrics Changes - Research and development expenses increased to $20.1 million for Q2 2025 from $15.1 million in Q2 2024, driven by BLA enabling processes and clinical trial activities [53] - General and administrative expenses rose to $8.6 million for Q2 2025 compared to $7.3 million in Q2 2024, primarily due to higher legal and professional fees [53] - Net loss for Q2 2025 was $26.9 million or $0.09 per share, compared to a net loss of $20.9 million or $0.09 per share for Q2 2024 [54] - As of June 30, 2025, the company had $312.8 million in cash and cash equivalents, reflecting gross proceeds of $230 million from a follow-on financing [54][55] Business Line Data and Key Metrics Changes - The REVEAL pivotal trial for TATIA-102 has commenced site activation, with patient enrollment expected to begin in Q4 2025 [11][12] - In the Part A data of the REVEAL trials, all 10 patients treated with TATIA-102 gained or regained one or more developmental milestones, indicating a 100% response rate [15][32] Market Data and Key Metrics Changes - Rett syndrome affects an estimated 15,000 to 20,000 patients across the U.S., Europe, and the UK, highlighting the market potential for TATIA-102 [12][13] Company Strategy and Development Direction - The company aims to redefine the treatment landscape for Rett syndrome with TATIA-102, a gene therapy targeting the genetic root cause of the disease [13][14] - The pivotal trial design focuses on the developmental plateau population, where the likelihood of achieving developmental milestones is approximately zero percent after age six [15][27] - The company has established a two-study approach to generate safety and efficacy data across the broad Rett syndrome population [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made towards the potential registration of TATIA-102, with a clear path forward following alignment with the FDA [11][57] - The company anticipates reporting new supplemental clinical data from Part A of the REVEAL trials in Q4 2025, supporting the therapeutic impacts of TATIA-102 [57] Other Important Information - The company completed a public follow-on offering that extended its cash runway into 2028 [16] - The pivotal trial will evaluate the percentage of patients in the developmental plateau population who gain or regain developmental milestones, with each patient serving as their own control [20][22] Q&A Session Summary Question: Is the 100% response rate for the pivotal trial primary endpoint in Part A the bar for Part B? - Management noted that while the results in Part A are compelling, maintaining a 100% standard is difficult. The statistical plan for Part B will use a null hypothesis of 6.7% for milestone gains, which is significantly lower than the observed results in Part A [59][60] Question: Are there specific time points for milestone occurrences? - Management indicated that improvements are seen over time, with gains typically occurring at most follow-up visits. Some critical gains may not be captured in the milestone assessment but still represent significant improvements in daily functioning [63][66] Question: How does the gene therapy differentiate from competitors? - The company emphasized its unique approach in defining clinical efficacy through meaningful functional gains, supported by a comprehensive natural history dataset. This sets it apart from competitors and aligns with regulatory expectations [69][72] Question: Will there be pushback on using interim readouts for BLA filing? - Management confirmed that the interim analysis approach was discussed with the FDA and is based on robust data from Part A, which supports the primary endpoint at both six and twelve months [79][82] Question: What to expect from the new supplemental REVEAL Part A data in Q4? - Management anticipates sharing additional data points, including video documented milestones and their impact on daily living, at both a medical conference and a company update [84][85]

Financial Data and Key Metrics Changes - In Q2 2025, net product revenue was $20.9 million, up from $9 million in Q1 2025, indicating strong momentum in the product launch [14][6] - The net loss for Q2 2025 was $47.9 million, reduced from a loss of $58.3 million in Q2 2024 [17] - Cash, cash equivalents, and marketable securities totaled $454.3 million at the end of Q2 2025, down from $588 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - Product sales for the first six months of the launch reached $29.9 million, with a total of 46 centers authorized for the use of Ocatsol [6][7] - Cost of sales in Q2 2025 was $24.4 million, which includes costs for products delivered but not yet administered [15] - Research and development expenses decreased to $27.4 million in Q2 2025 from $36.6 million in the same period in 2024 [16] Market Data and Key Metrics Changes - The company has achieved 90% total US medical lives covered and aims to reach over 60 authorized centers by year-end [7] - The company does not expect EU sales in 2025 and 2026 due to limited resources and the need for economically viable market access [9] Company Strategy and Development Direction - The company is focused on expanding the use of Ovicell beyond adult patients with relapsed-refractory ALL and is making progress in autoimmune diseases [12][20] - The company is taking a disciplined approach to market access in Europe, evaluating country by country for economically viable launches [9][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the product's reception and the potential for increased patient enrollment as administrative adjustments are resolved by Q4 [8][30] - The company plans to release updated data from its Phase I study at the ACR meeting in October and expects to dose the first patients in several upcoming studies [20][98] Other Important Information - The company received conditional marketing authorization in the UK and from the European Commission, with ongoing market access discussions [8][9] - The company is broadening real-world experience in the US to support market access conversations elsewhere [9] Q&A Session Summary Question: What is the status of the Germany launch? - Management indicated that market access methodologies in Europe are challenging, particularly for CAR T programs, and emphasized a methodical approach to launching in different countries [24][26] Question: How will revenue recognition change with the split reimbursement? - The CFO clarified that revenue recognition has shifted to a 50/50 split between the first and second administration, with expectations for enrollment and sales to accelerate post-implementation [28][29] Question: What is the feedback from the US community regarding the product? - Management reported very positive feedback, with early reorder activity from treatment centers indicating strong acceptance [38] Question: What is the timeline for the UK and Germany launches? - Management expects potential launches in the UK by early next year, contingent on favorable negotiations, while Germany's timeline remains uncertain [65][66] Question: How many patients were treated in Q2? - Management did not provide specific numbers but indicated that the revenue can be backtracked based on therapy costs [90] Question: What is the expected data release for the lupus Phase II trial? - Management stated that it is premature to provide a timeline for data from the lupus nephritis study, as patient enrollment is just beginning [99]

eToro Group Ltd (ETOR) Q2 2025 Earnings Call August 12, 2025 08:30 AM ET Speaker0Thank you, everyone, for joining Itoro's Second Quarter twenty twenty five Earnings Call. My name is Daniel Meir, Head of Global Investor Relations. Here with me today are Yoni Assia, Founder and Chief Executive Officer and Maron Shanee, Chief Financial Officer. This morning at seven a. M.Eastern Time, Itora released its second quarter twenty twenty five results. In the Investors section of our website, you will find the earnin ...

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $29 million, representing a 13% year-over-year increase, driven by enhanced contract terms and a 9% growth in average selling price (ASP) [22][6][5] - Adjusted EBITDA was approximately $3.7 million, compared to $1.1 million in the prior year, marking a more than 3x increase [23][6] - Gross margin for the quarter was approximately 33%, slightly higher than in 2024 [22] Business Line Data and Key Metrics Changes - The PAC (Powdered Activated Carbon) business has shown a successful turnaround, with all sales contracts now being net contributors in 2025, a significant improvement from 24% of volumes being loss-making as of December 2022 [24][6] - The GAC (Granular Activated Carbon) line has been successfully commissioned, with a nameplate capacity of 25 million pounds expected to be reached within six months [5][12] Market Data and Key Metrics Changes - The company has reduced its exposure to the mercury emissions market to under 40% of volumes, diversifying into new markets for both PAC and GAC, which improves margins and overall financial performance [8][9] - The granular activated carbon market is experiencing persistent supply shortages, with demand expected to grow significantly due to regulatory changes related to PFAS [10][11] Company Strategy and Development Direction - The company aims to enhance profitability through operational optimization and cost reduction initiatives while expanding into higher growth, higher margin GAC business [7][29] - Plans for a second GAC line are underway, with a final investment decision expected by the end of 2025 [14][29] Management's Comments on Operating Environment and Future Outlook - Management views the current regulatory environment as favorable, with the EPA's pragmatic approach to PFAS regulation seen as beneficial for the business [18][19] - The company is confident in its ability to finance future growth through cash flow generation and existing debt facilities, without the need for further equity issuance [66][68] Other Important Information - The company is engaged in testing programs for asphalt emulsion, which could represent a significant future revenue source [20][78] - The company has reiterated its 2025 capital expenditure forecast of between $8 million and $12 million [26] Q&A Session Summary Question: Can you elaborate on the key milestones in the commissioning process at Red River? - Management confirmed that the operations team is focused on reaching full nameplate capacity of 25 million pounds as quickly as possible, with ongoing tweaks to improve production rates [35][36] Question: What is the expected cost for the second GAC line? - Management indicated that costs are being evaluated and enhancements from the first line will likely reduce expenses for the second line [39][40] Question: What is the timeline for moving from initial sales to contracts in the RNG market? - The timeline varies from one to eight months depending on customer testing requirements, with a focus on maintaining a balanced customer mix across different industries [41][43] Question: What impact did commissioning have on gross margins? - Approximately $1.9 million in costs associated with preproduction inventory were reclassified to R&D expenses, with gross margins expected to remain above 33% going forward [46][47] Question: How confident is the company in financing the second line without issuing equity? - Management expressed confidence in financing through cash flow generation and debt availability, emphasizing a gradual investment approach [66][68]

Nano-X Imaging (NNOX) Q2 2025 Earnings Call August 12, 2025 08:30 AM ET Speaker0Good day and thank you for standing by. Welcome to the Nanox Imaging Second Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, we will open up for questions. Call.I would now like to hand it over to your first speaker, Mike Cavanagh, Investor Relations. Please go ahead.Speaker1Good morning and thank you for joining us today. Earlier today, Nanox I ...

Liquidia Corp (LQDA) Q2 2025 Earnings Call August 12, 2025 08:30 AM ET Speaker0Good morning, and welcome everyone to the Liquidia Corporation Second Quarter twenty twenty five Financial Results and Corporate Update Conference Call. My name is Nadia, and I will be your conference operator today. Currently, all participants are in listen only mode. Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue for up for questions.I would ...

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $8.5 million, down from $12.3 million in the prior year, primarily due to government budgeting processes impacting orders [18] - Product revenues decreased to $7.5 million from $11.1 million in Q2 2024 [18] - Funded research and development revenues fell by $900,000 to $300,000, attributed to the completion of the CR3 medical headset development [19] - The net loss for Q2 2025 was $5.2 million or $0.03 per share, compared to a net loss of $5.9 million or $0.05 per share in Q2 2024 [21][22] Business Line Data and Key Metrics Changes - R&D expenses increased to $1.9 million, up approximately $100,000 from the previous year, with internal R&D expenses rising by $300,000 [20] - SG&A expenses were $7.9 million in Q2 2025, compared to $7.3 million in Q2 2024, primarily due to a decrease in legal fees [20] Market Data and Key Metrics Changes - The European nations and NATO allies are projected to spend over $1 trillion in defense spending, making this region critical for growth [6] - The partnership with Theon is expected to drive increased revenue and market share in Europe, Southeast Asia, and with NATO allies [5][6] Company Strategy and Development Direction - The company is focusing on application-specific solutions and has a strategic partnership with Theon International to enhance its market position [5][9] - A three-year strategic plan has been developed with Theon for revenue growth and technology sharing [9] - The company aims to capitalize on macro trends in defense spending and technology advancements [7][10] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q2 2025 did not meet expectations due to government budget uncertainty but noted that the order book is recovering [10] - The company is optimistic about future revenue recognition from delayed orders and expects significant R&D awards soon [11] - Management emphasized the importance of their technology in enhancing soldier safety and the evolving nature of warfare [16][47] Other Important Information - The company introduced its first phase of optical inspection, which is expected to save significant operating expenses and improve throughput [11] - The new AI-enabled neural display hardware prototype is a significant technological advancement for the company [12] Q&A Session Summary Question: Size of the opportunity with Theon - Management indicated that there are multiple opportunities, including internal spending on microdisplays and application-specific solutions like DayVAS and DarkWave [27][28] Question: Book to bill number for Q2 - Management confirmed a positive book to bill ratio for Q2, although it was lower than expected, with a significant amount of funded R&D orders anticipated [32] Question: Automation and gross margin advantages - Management reported that the introduction of optical inspection solutions is expected to yield operational expense recovery and further automation is planned for Q4 [36][37]

Financial Data and Key Metrics Changes - Net product revenues for the second quarter were $18.1 million, and for the first half, they were $35.5 million, both slightly higher compared to the same periods in the prior year [4][28] - The company reported a net loss of $56.6 million for the second quarter, compared to a net loss of $36.5 million in the same period of 2024, primarily due to one-time restructuring and impairment costs [29] - Total operating expenses for the quarter were $47.8 million on a non-GAAP basis, representing an 8% increase over the prior year, driven by higher R&D costs [28][29] Business Line Data and Key Metrics Changes - The company is focusing on the commercialization of ZENLANTA, which has shown promising data in clinical trials, particularly in combination with glufetamab [5][10] - The LOTUS-seven trial data presented at conferences indicated a complete response rate of 86.7% across 30 efficacy evaluable LBCL patients [5][27] - The company plans to expand enrollment to 100 patients at the selected dose to support regulatory discussions [6][9] Market Data and Key Metrics Changes - The company estimates that ZENLANTA could reach peak sales of $600 million to $1 billion in the U.S. market, with significant opportunities in both DLBCL and indolent lymphomas [11][12] - The DLBCL treatment landscape is divided into complex therapies and broadly accessible therapies, with the latter expected to grow as ZENLANTA is positioned as a preferred option [12][13] Company Strategy and Development Direction - The company is strategically focusing resources on ZENLANTA commercialization and has discontinued early development efforts for other preclinical programs in solid tumors [8][9] - The company aims to position itself for long-term growth by reducing operating expenses and extending its cash runway into 2028 through a recent private placement [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unmet medical need in the second line plus DLBCL landscape and the potential of LOTUS trials to address this need [38] - The company anticipates multiple data catalysts in the remainder of 2025 and 2026, with potential regulatory submissions and approvals expected [31][32] Other Important Information - The company incurred $13.1 million in restructuring and impairment costs related to the closure of its UK facility [29] - The company plans to engage with regulatory authorities regarding the LOTUS trials and explore potential pathways for approval [56][58] Q&A Session Summary Question: Impact of Roche's complete response letter on DLBCL market - Management noted that while details of the CRL are unknown, they remain confident in the unmet medical need in the second line plus DLBCL landscape and the positioning of LOTUS trials to address this need [38][39] Question: Status of LOTUS V overall survival analysis - Management indicated that it is difficult to speculate on the maturity of overall survival data by year-end, but they will provide updates once the pre-specified number of PFS events is reached [42][44] Question: Durability of responses in LOTUS trials - Management highlighted the unprecedented complete response rates observed in LOTUS trials and expressed confidence in the durability of these responses, with plans to share more data as it matures [48][50] Question: Communication of LOTUS-seven data - Management stated that they are considering the best way to communicate LOTUS-seven data, whether through a company update or at a medical congress, depending on data maturity [59][60] Question: Indolent lymphomas and NCCN inclusion - Management expressed confidence in the ongoing Phase II IIT for MZL and noted that a CR rate of 40% or above would be significant for NCCN inclusion [64][65]

Financial Data and Key Metrics Changes - Net investment income (NII) per share was $0.39 for the quarter, corresponding to an annualized return on equity (ROE) of 10.5% [11] - GAAP net income per share was $0.19, corresponding to an annualized ROE of 5.2% [11] - Net asset value (NAV) per share was $14.75, down 1.2% compared to the prior quarter [11] Business Line Data and Key Metrics Changes - MFIC made $262 million of new commitments across 29 transactions during the quarter [12] - The weighted average spread on new commitments was 538 basis points, with a slight increase compared to the prior quarter [12][23] - The weighted average net leverage on new commitments was 4.0 times, down from 4.2 times in the prior quarter [23] Market Data and Key Metrics Changes - The quarter began with heightened volatility due to U.S. tariffs, but market sentiment improved as tariffs were paused and trade deals were struck [20] - The labor market showed resilience with steady unemployment, and the Federal Reserve kept its policy rate unchanged [20] - The weighted average yield at cost of the direct origination portfolio was 10.5%, down from 10.7% in the prior quarter [35] Company Strategy and Development Direction - The company is focused on lending to the core middle market on a first lien senior secured basis, which offers attractive risk-adjusted returns [22] - The reduction in exposure to Merx is expected to provide capital for deployment into first lien middle market loans, which are believed to deliver higher returns [17] - The company intends to redeploy capital repaid from Merx to enhance earnings power and strengthen dividend coverage [18] Management's Comments on Operating Environment and Future Outlook - Management noted that the M&A pipeline is building, with sponsors remaining active despite previous uncertainties [55] - The company expects a busy second half of the year with plenty of opportunities to deploy capital [55] - Management expressed confidence in covering the declared dividend of $0.38 per share through net investment income, despite potential base rate pressures [90] Other Important Information - The company reported total investment income of approximately $81.3 million, up 3.2% compared to the prior quarter [33] - Total principal debt outstanding was $2.05 billion, with total net assets standing at $1.3 billion [38] - The company received an $8.5 million pay down from Merx during the quarter [24] Q&A Session Summary Question: Can you clarify the structure of the remaining investment in Merx? - The remaining investment consists of four aircraft and a servicing platform, with 40% of the remaining exposure related to servicing contracts [43][44] Question: What are the expectations for investment activity in the second half of the year? - The company anticipates a busy second half with a growing M&A pipeline and active sponsors, which should provide ample opportunities for deployment [55] Question: How does the company view the current leverage levels? - The company is comfortable with the current leverage levels and expects them to remain within target ranges, especially with anticipated M&A activity [56][58] Question: What is the expected impact of the Merx transactions on NAV? - The Merx transactions are expected to result in a positive impact to NAV in the high single-digit per share range, specifically between $0.06 to $0.09 [94]