WEST LAFAYETTE, Ind., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Inotiv, Inc. (NASDAQ: NOTV) (the “Company”, or “Inotiv”), a leading contract research organization specializing in nonclinical and analytical drug discovery and development services and research models and related products and services, today announced that it will issue its financial results for the fiscal 2026 first quarter ended December 31, 2025, on Monday, February 9, 2026, before the stock market opens. The Company will host a conference call tha ...

Core Insights - Inotiv, Inc. announced a strategic initiative to integrate LifeNet Health's proprietary TruVivo system into its Discovery and Translational Sciences business, enhancing its drug development capabilities [1][3] Group 1: Company Overview - Inotiv, Inc. is a leading contract research organization focused on nonclinical and analytical drug discovery and development services, aiming to improve efficiency and reduce costs in bringing new drugs and medical devices to market [4] - The company is dedicated to supporting research and development objectives while promoting a healthier and safer world [4] Group 2: Technology and Collaboration - LifeNet Health has developed the TruVivo system, which utilizes primary human hepatocytes with human-derived feeder cells to create in vitro models that better predict human responses to therapies, addressing significant challenges in drug development [2] - The integration of the TruVivo platform into Inotiv's offerings will enhance the alignment of preclinical models with human biology and expand human-relevant tissue models beyond the liver, facilitating innovation across various human diseases [3] Group 3: Mission and Vision - Both Inotiv and LifeNet Health share a mission to accelerate scientific innovation that translates into meaningful human impact, emphasizing the importance of human-relevant technologies in preclinical research [3][5]

Core Insights - Inotiv, Inc. has announced a strategic collaboration with VUGENE to enhance AI-assisted drug discovery and improve data-driven insights across the drug development continuum [1][2]. Company Overview - Inotiv, Inc. is a leading Contract Research Organization (CRO) that specializes in nonclinical and analytical drug discovery and development services, as well as research models and related products [1][4]. - The company focuses on increasing efficiency, improving data quality, and reducing costs associated with bringing new drugs and medical devices to market [4]. Collaboration Details - The partnership will integrate VUGENE's cloud-based bioinformatics and computational platform into Inotiv's Discovery & Translational Sciences Division, facilitating more efficient analysis of complex biological data [2][3]. - This collaboration aims to enhance Inotiv's capabilities in interpreting various molecular datasets, ultimately improving predictions of drug efficacy and safety during early-stage research [2][3]. Strategic Goals - The collaboration is expected to enable clients to make faster and more informed decisions by leveraging VUGENE's AI-enabled bioinformatics platform [3]. - The partnership represents an opportunity for VUGENE to expand the application of its computational technologies in real-world research environments [3][5]. Technological Integration - VUGENE's platform integrates biological data from multiple sources, including (epi)genomics, transcriptomics, proteomics, and metabolomics, to elucidate disease mechanisms and therapeutic modes of action [5].

Revenue and Financial Performance - Revenue for the fiscal year ended September 30, 2025, increased to $513,024 from $490,739 in the fiscal year ended September 30, 2024, representing a 4.7% increase in RMS revenue and a 4.3% increase in DSA revenue[300] - DSA revenue for the twelve months ended September 30, 2025, was $187,943, an increase of $7,827 or 4.3% compared to the previous year[305] - RMS revenue increased to $325,081 for the fiscal year ended September 30, 2025, representing a growth of $14,458 or 4.7%[308] - The Company reported a consolidated net loss of $68,625 for the twelve months ended September 30, 2025, compared to a net loss of $108,885 for the same period in 2024, reflecting an improvement of 37%[319] - Net loss attributable to common shareholders decreased to $68,625 from $108,445, primarily due to the reduction in operating loss[302] - For the fiscal year ended September 30, 2025, the operating loss was $30,902, a decrease of $55,504 from the operating loss of $86,406 in the previous fiscal year[301] - Operating loss decreased to $30,902 for the fiscal year ended September 30, 2025, from $86,406 in fiscal 2024, representing a reduction of 64.2%[320] Cash Flow and Liquidity - As of September 30, 2025, the company had $21,741 in cash and cash equivalents, with total debt amounting to $402,123[303] - Cash and cash equivalents as of September 30, 2025, were $21,741, slightly up from $21,432 as of September 30, 2024[328] - Net cash used in operating activities was $10,455 for fiscal 2025, compared to $6,805 for fiscal 2024, indicating increased cash outflows[328] - Financing activities generated net cash of $23,701 in fiscal 2025, significantly higher than $9,675 in fiscal 2024, primarily due to proceeds from common share issuance[333] Debt and Financing - The company is exploring potential debt refinancing alternatives with the assistance of Perella Weinberg Partners[304] - The Company is exploring potential debt refinancing alternatives and is in discussions with lenders regarding current business conditions[326] - The Company issued $22,000 in Second Lien Notes and warrants to purchase 3,946,250 shares of common stock for $17,000 in cash and the cancellation of $8,333 of existing notes[341] - The Company issued $140,000 principal amount of Convertible Senior Notes, with an additional $15,000 option exercised by the initial purchaser[385] - The aggregate principal amount of Notes remaining outstanding after cancellations is $131,667[386] - The Company has incurred unamortized debt issuance costs of $2,093 and $3,031 related to the Notes as of September 30, 2025, and 2024, respectively[389] Operational Efficiency and Cost Management - The company achieved approximately $17,000 to $19,000 in net annual cost savings as a result of restructuring and site optimization plans[283] - Phase Two of the site optimization plan is expected to require a capital investment of approximately $6,500 and provide net annual savings of $6,000 to $7,000[284] - The Company plans to optimize capital allocation and improve operating results through increased revenue from NHP-related products and services in fiscal 2026[325] Market and Client Growth - The company anticipates continued growth in its NHP client base and has pre-sold NHP inventory to deliver a more consistent revenue stream[281] - The company is focused on expanding existing client relationships and acquiring new clients, particularly in the DSA segment to serve the emerging biopharmaceutical market[278] Legal and Compliance Matters - The company recorded an $11,000 liability and an insurance recovery receivable of $11,000 as of September 30, 2025, related to proposed settlements of securities class action and derivative lawsuits[293] - The company is in the process of providing notifications regarding a cybersecurity incident that occurred between August 5-8, 2025, with ongoing evaluations of its operational and financial impacts[294] Tax and Accounting - The effective income tax rate increased to 21.8% in fiscal 2025 from 16.7% in fiscal 2024, with income tax benefits recorded of $19,143 and $21,875, respectively[318] - The company uses the asset and liability approach for financial accounting and reporting of income taxes, with deferred income taxes reflecting temporary differences between financial reporting and tax purposes[414] - The company recognizes deferred tax assets only if it believes they are more likely than not to be realized, considering future taxable income and tax-planning strategies[415] Asset Management - Goodwill is reviewed for impairment annually, with an assessment date of September 30, and is not amortized[419] - The company amortizes definite-lived intangible assets over their estimated useful lives, with customer relationships ranging from 5 to 13 years[423] - Long-lived assets are reviewed for impairment whenever events indicate that the carrying amount may not be recoverable, based on future cash flow estimates[424]

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

Financial Data and Key Metrics Changes - For Q4 fiscal 2025, total revenue was $138.1 million, an increase of $7.7 million or 5.9% compared to Q4 fiscal 2024, primarily driven by the DSA segment [9][18] - For fiscal year 2025, total revenue was $513 million, an increase of $22.3 million or 4.5% compared to $490.7 million for fiscal 2024 [9][18] - The overall operating loss for Q4 fiscal 2025 decreased to $6.8 million from $13.2 million in Q4 fiscal 2024 [22] - Consolidated net loss attributable to common shareholders for Q4 fiscal 2025 was $8.6 million or a $0.25 loss per diluted share, compared to a loss of $18.9 million or $0.73 per diluted share in Q4 fiscal 2024 [26] Business Line Data and Key Metrics Changes - DSA revenue for Q4 fiscal 2025 was $51.6 million, a 15.7% increase year-over-year, driven by discovery and translational science services [19] - RMS revenue for Q4 fiscal 2025 was $86.5 million, an increase of $700,000 or 0.8% compared to Q4 fiscal 2024 [21] - DSA backlog was $138.2 million at September 30, 2025, compared to $129.9 million at September 30, 2024 [19] Market Data and Key Metrics Changes - The DSA backlog conversion rate was 37.4% for Q4 fiscal 2025, the highest quarterly conversion rate in three years [11] - Net new DSA Awards for Q4 fiscal 2025 were $54.2 million, a 61% increase over Q4 fiscal 2024 [20] Company Strategy and Development Direction - The company aims to improve cash flow and margins while focusing on customer metrics, with specific goals to enhance DSA revenue and margins [7] - The RMS site consolidation project is on track, with plans to close a total of 13 RMS facilities, which is expected to yield annual savings of $6 million to $7 million [12] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from a cybersecurity incident but expressed satisfaction with the recovery and ongoing demand trends [8][33] - The company is optimistic about maintaining revenue growth and improving margins, with a focus on cost reduction in the RMS business [39][40] Other Important Information - The company engaged Perella Weinberg Partners for financial advisory services to explore potential debt refinancing alternatives [8] - Cash balance increased to $21.7 million as of September 30, 2025, compared to $6.2 million at June 30, 2025 [16][27] Q&A Session Summary Question: What were the headwinds faced in the quarter? - Management identified a cybersecurity incident as the major headwind, leading to increased costs and operational challenges [33][34] Question: What are the quarter-to-date trends regarding ordering patterns? - Management noted that the upcoming quarter is typically weaker due to holiday seasonality but expressed optimism based on recent revenue increases [38][39] Question: How is the company positioned regarding FDA guidance on animal models? - Management indicated minimal exposure to monoclonal antibodies and does not foresee significant impacts from the FDA's guidance [44][45] Question: What are the expectations for customer budgets in 2026? - Management observed an increase in quoting activity and expressed optimism about potential revenue growth for the next year [46][48] Question: How quickly can studies start for clients? - The company typically starts smaller studies within weeks, while larger animal safety assessments may take three to nine months [52]

Financial Data and Key Metrics Changes - For Q4 fiscal 2025, total revenue was $138.1 million, an increase of $7.7 million or 5.9% compared to Q4 fiscal 2024, primarily driven by the DSA segment [9][18] - For fiscal year 2025, total revenue was $513 million, an increase of $22.3 million or 4.5% compared to $490.7 million for fiscal 2024 [9][18] - The overall operating loss for Q4 fiscal 2025 decreased to $6.8 million from $13.2 million in Q4 fiscal 2024 [21] - Consolidated net loss attributable to common shareholders in Q4 fiscal 2025 totaled $8.6 million or a $0.25 loss per diluted share, compared to a loss of $18.9 million or $0.73 per diluted share in Q4 fiscal 2024 [26] Business Line Data and Key Metrics Changes - DSA revenue for Q4 fiscal 2025 was $51.6 million, a 15.7% increase year-over-year, driven by discovery and translational science services [19][20] - RMS revenue for Q4 fiscal 2025 was $86.5 million, an increase of $700,000 or 0.8% compared to Q4 fiscal 2024 [20] - DSA backlog was $138.2 million at September 30, 2025, compared to $129.9 million at September 30, 2024 [19] Market Data and Key Metrics Changes - The book-to-bill ratio for DSA for Q4 fiscal 2025 was 1.08 to 1, indicating strong demand [19] - DSA cancellations and negative change orders in Q4 fiscal 2025 were approximately 29% lower compared to the prior year [20] Company Strategy and Development Direction - The company aims to improve DSA revenue and margins while continuing RMS site consolidation to reduce costs [6][9] - The plan includes closing 13 RMS facilities over three years to modernize operations and improve efficiency [12] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from a cybersecurity incident but expressed satisfaction with the recovery and ongoing demand [7][16] - The company remains optimistic about maintaining revenue growth and improving margins in the upcoming quarters [37][41] Other Important Information - The company engaged Perella Weinberg Partners for financial advisory services to explore debt refinancing alternatives [8] - Cash from operations in Q4 fiscal 2025 was $14.3 million, increasing the cash balance to $21.7 million [16][27] Q&A Session Summary Question: What were the headwinds faced in the quarter? - The major headwind was a cybersecurity incident that caused additional expenses and operational challenges, though the company managed to achieve significant awards despite this [31][32] Question: What are the quarter-to-date trends regarding ordering patterns? - The company typically sees a slowdown during the holiday season, but recent quoting activity has been encouraging, with a focus on cost reduction in the RMS business [35][36] Question: How is the company positioned regarding FDA guidance on animal models? - The company has minimal exposure to monoclonal antibodies and does not anticipate significant impacts from the FDA's new guidance [39][40] Question: What are the expectations for customer budgets in the upcoming year? - The company is seeing an increase in quoting activity and anticipates a substantial increase in bookings, indicating a positive outlook for next year's budgets [41] Question: How quickly can studies start for clients? - The company can typically start smaller studies within weeks, while larger animal safety assessments may take three to nine months [42]

Core Insights - Inotiv, Inc. reported a 5.9% increase in revenue for Q4 FY 2025, reaching $138.1 million, and a 4.5% increase for FY 2025, totaling $513.0 million [1][12] - The operating loss for Q4 FY 2025 decreased by 48.5% to $6.8 million, while the annual operating loss for FY 2025 decreased by 64.2% to $30.9 million [1][6] Financial Performance - Q4 FY 2025 revenue was $138.1 million, up from $130.4 million in Q4 FY 2024, driven by a $7.1 million increase in DSA revenue and a $0.7 million increase in RMS revenue [7][10] - FY 2025 revenue increased to $513.0 million from $490.7 million in FY 2024, with RMS revenue up by $14.5 million and DSA revenue up by $7.8 million [12][13] - Consolidated net loss for Q4 FY 2025 was $8.6 million, or 6.2% of total revenue, compared to a loss of $18.9 million, or 14.5% of total revenue, in Q4 FY 2024 [7][10] - Adjusted EBITDA for Q4 FY 2025 was $11.8 million, or 8.5% of total revenue, compared to $5.4 million, or 4.1% of total revenue, in Q4 FY 2024 [7][10] Segment Performance - DSA revenue for Q4 FY 2025 was $51.6 million, a 15.7% increase from $44.6 million in Q4 FY 2024, while RMS revenue was $86.5 million, a slight increase of 0.8% from $85.8 million [2][32] - For FY 2025, DSA revenue totaled $187.9 million, up 4.3% from $180.1 million in FY 2024, and RMS revenue reached $325.1 million, a 4.7% increase from $310.6 million [2][12] Operational Highlights - The book-to-bill ratio for Q4 FY 2025 was 1.08x for the DSA services business, indicating strong demand [7] - DSA backlog increased to $138.2 million at September 30, 2025, up from $129.9 million at the same time last year [7] Management Commentary - The CEO emphasized the focus on improving cash flow, margins, and client metrics, noting that the revenue increase was in line with expectations [3][4] - The company remains committed to client satisfaction and delivering high-quality products and services, with a significant increase in DSA net awards by approximately 61% year-over-year [4]

Core Insights - Inotiv achieved a remarkable revenue growth of 448% from fiscal year 2021 to fiscal year 2024, earning a spot at 182 on the Deloitte Technology Fast 500™ ranking [1][2] - The company's success is attributed to its client-focused approach, strategic acquisitions, and the development of complementary services that enhance client support [2] - Inotiv has been recognized as a Deloitte Technology Fast 500™ winner for three consecutive years, reflecting both client trust and team dedication [2] Company Overview - Inotiv, Inc. is a leading contract research organization that provides nonclinical and analytical drug discovery and development services, focusing on improving efficiency and reducing costs in bringing new drugs and medical devices to market [5] - The company aims to support researchers in realizing the full potential of their critical research and development projects, contributing to a healthier and safer world [5] Industry Context - The Deloitte Technology Fast 500™ ranks the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America based on percentage revenue growth [3] - The 2025 rankings highlight a mix of established leaders and new innovators, with private companies showing significant agility and growth potential in competitive markets [2][3]

Core Viewpoint - Inotiv, Inc. will release its financial results for the fiscal year 2025 on December 3, 2025, and will host a conference call to discuss these results [1]. Company Overview - Inotiv, Inc. is a leading contract research organization that specializes in nonclinical and analytical drug discovery and development services, as well as research models and related products [3]. - The company's focus is on enhancing efficiency, improving data quality, and reducing costs associated with bringing new drugs and medical devices to market [3]. - Inotiv is dedicated to supporting research and development objectives, aiming to help researchers maximize the potential of their projects while contributing to a healthier and safer world [3].