Company Overview - Inotiv, Inc is a leading contract research organization (CRO) providing drug discovery and development services to the pharmaceutical and medical device industries[7] - The company's market capitalization was approximately $69 million as of April 30, 2025[6] - Inotiv was founded in 1974 and underwent a strategic reinvention in 2017[7] Financial Performance and Growth - Inotiv has a history of integrating acquisitions to enhance organic revenue growth[8] - The company plans for $17 million-$19 million in annual net savings compared to FY2022 through infrastructure right-sizing, strategic capital investments, and supply chain synergies[11] - Capital expenditures (CAPEX) are projected to average less than 40% of annual revenue in FY2025, compared to a 5-year historical average of approximately 8%[31] Business Segments and Services - Services account for 45% of total revenue, followed by Large Animals at 29%, Small Animals at 13%, and Teklad at 11% (trailing 12 months ended March 31, 2025)[13] - The company operates through two segments: Discovery and Safety Assessment (DSA) and Research Models and Services (RMS)[7] - North America accounts for 80% of customer geography, followed by EMEA at 15% and the Pacific Rim at 5%[23]

Company Overview - Inotiv, Inc is a leading contract research organization (CRO) providing drug discovery and development services to the pharmaceutical and medical device industries[7] - The company's market capitalization was approximately $69 million as of April 30, 2025[6] - Inotiv was founded in 1974 and underwent a strategic reinvention in 2017[7] Financial Performance and Growth - Inotiv has a history of integrating acquisitions to enhance organic revenue growth[8] - The company plans for $17 million-$19 million in annual net savings compared to FY2022 through infrastructure right-sizing, strategic capital investments, and supply chain synergies[11] - Capital expenditures (CAPEX) are projected to average less than 40% of annual revenue in FY2025, compared to a 5-year historical average of approximately 8%[31] Business Segments and Services - Services account for 45% of total revenue, followed by Large Animals at 29%, Small Animals at 13%, and Teklad at 11% (trailing 12 months ended March 31, 2025)[13] - The company operates through two segments: Discovery and Safety Assessment (DSA) and Research Models and Services (RMS)[7] - North America accounts for 80% of customer geography, followed by EMEA at 15% and the Pacific Rim at 5%[23]

Company Overview - Inotiv, Inc. is a leading contract research organization specializing 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 aims to support discovery and development objectives while contributing to a healthier and safer world [3] Upcoming Event - Robert Leasure Jr., President and CEO of Inotiv, will present at the Jefferies Global Healthcare Conference in New York on June 4 at 3:45 p.m. ET [1] - The live webcast of the presentation will be available in the "Investors" section of Inotiv's website and will be archived for approximately 90 days [2]

Core Insights - Fortrea reported a solid start to 2025 with a focus on disciplined execution of its strategy and improving efficiency to better serve customers [2][4] Financial Performance - Revenue for Q1 2025 was $651.3 million, a decrease from $662.1 million in Q1 2024 [3] - GAAP net loss for Q1 2025 was $562.9 million, with a diluted loss per share of $6.25, which included a non-cash goodwill impairment charge of $488.8 million [4][9] - Adjusted EBITDA for Q1 2025 was $30.3 million, compared to $27.1 million in Q1 2024 [4][9] - The backlog as of March 31, 2025, was $7,721 million, with a book-to-bill ratio of 1.02x for the quarter [4][9] Guidance - The company reiterated its full-year 2025 guidance, targeting revenues between $2,450 million and $2,550 million and adjusted EBITDA between $170 million and $200 million [5] Leadership Changes - Fortrea announced that Peter M. Neupert will serve as Interim CEO and Board Chair as Tom Pike steps down from his role effective May 13, 2025 [6] Cash Flow and Balance Sheet - Net cash used for operating activities in Q1 2025 was $124.2 million, with free cash flow also reported at $(127.1) million [21][37] - Total assets as of March 31, 2025, were $3,121.1 million, down from $3,579.2 million at the end of 2024 [20]

Core Points - Thomas Pike is stepping down as CEO and Chairman of Fortrea, with Peter M. Neupert appointed as Interim CEO and Board Chair starting May 13, 2025 [1][2] - The transition is part of a succession planning process, with an executive search already in advanced stages [1] - Neupert expressed gratitude for Pike's leadership during a challenging period and noted the company's progress towards independence since its spin-off [2] Company Overview - Fortrea is a leading global contract research organization (CRO) that provides clinical development solutions to the life sciences industry [4] - The company partners with biopharmaceutical, biotechnology, medical device, and diagnostic companies to drive healthcare innovation [4] - Fortrea offers phase I-IV clinical trial management, clinical pharmacology, and consulting services, leveraging over 30 years of experience across more than 20 therapeutic areas [4]

Financial Data and Key Metrics Changes - For Q2 of fiscal 2025, total revenue was $124.3 million, up from $119.0 million in Q2 of fiscal 2024, representing a year-over-year increase of $5.3 million or 4.4% [9][26] - Adjusted EBITDA for Q2 was $8.0 million, or 6.4% of total revenue, compared to $3.1 million, or 2.6% of total revenue in the prior year [28][29] - Consolidated net loss attributable to common shareholders was $14.9 million, or a loss of $0.44 per diluted share, compared to a loss of $48.1 million, or $1.86 per diluted share in Q2 of fiscal 2024 [28] Business Line Data and Key Metrics Changes - RMS segment revenue increased by $6.6 million or 9.1% year-over-year, primarily due to higher NHP revenue [9][26] - DSA revenue decreased to $45.3 million from $46.6 million in Q2 of fiscal 2024, driven by a decline in general toxicology services revenue [27] - DSA net new orders were $44.5 million, a 27% increase over Q2 of fiscal 2024, with a book-to-bill ratio of 1.01:1 [27][30] Market Data and Key Metrics Changes - The company noted geopolitical and macroeconomic risks affecting the industry, but expects continued year-over-year revenue growth for the next two quarters [9][24] - The company has not seen significant changes in demand due to current tariffs, although there is some cost inflation linked to them [23][24] Company Strategy and Development Direction - The company is focused on client satisfaction, integration of scientific services, and optimizing RMS site operations [8][10] - A revised RMS site optimization plan is expected to yield annual cost savings of $6 million to $7 million, with completion anticipated by March 2026 [11][12] - The company is adapting to FDA goals of reducing animal testing and is investing in technologies that align with these objectives [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about revenue growth in the upcoming quarters and a potential reversal in declines in discovery business [49] - The company is closely monitoring NIH funding impacts but has not yet seen significant effects on business [52][55] - Management remains confident in the ability to improve DSA margins and overall operational efficiency [62][69] Other Important Information - The company plans to hold an Investor Day on May 29 to discuss its strategic plan and focus on client excellence [90] - The company has settled a litigation case for approximately $7.6 million, which positively impacted its financials [8] Q&A Session Summary Question: Changes in marketing post-FDA announcement - Management has integrated new services into the discovery sales process and is seeing some growth, but not at the expected pace [36][37] Question: Focus areas in RMS optimization plan - The revised plan aims to improve efficiencies and reduce costs, with a focus on maximizing existing resources rather than expanding capacity [40][41] Question: Current demand and quoting activity - Management reported a positive start to the current quarter with good quoting and closing activity [45][47] Question: Impact of NIH funding on customer mix - No significant impact has been observed yet, although the company is monitoring the situation closely [52][55] Question: DSA margin improvement timeline - Management expects to see benefits from margin improvement efforts sooner rather than later, with some improvements already noted [67][69] Question: Pricing discounting trends - Price discounting has decreased compared to six to twelve months ago, with a more stable pricing environment currently [71][72] Question: Integration of scientific services - The integration involves improving project management systems and enhancing service delivery speed to add value for clients [79][80]

Financial Data and Key Metrics Changes - For Q2 of fiscal 2025, total revenue was $124.3 million, a 4.4% increase from $119 million in Q2 of fiscal 2024, primarily driven by an increase in RMS segment revenue [8][25] - Adjusted EBITDA for Q2 was $8 million, or 6.4% of total revenue, compared to $3.1 million, or 2.6% of total revenue in the same quarter last year [27][28] - Consolidated net loss attributable to common shareholders was $14.9 million, or a loss of $0.44 per diluted share, compared to a loss of $48.1 million, or $1.86 per diluted share in Q2 of fiscal 2024 [27] Business Line Data and Key Metrics Changes - RMS segment revenue increased by $6.6 million, or 9.1%, compared to Q2 of fiscal 2024, mainly due to higher NHP volumes sold [25][26] - DSA revenue decreased to $45.3 million from $46.6 million in Q2 of fiscal 2024, primarily due to a decline in general toxicology services revenue [26] - DSA net new orders were $44.5 million, a 27% increase over Q2 of fiscal 2024, with a book to bill ratio of 1.01:1 [26][28] Market Data and Key Metrics Changes - The company noted geopolitical and macroeconomic risks affecting the industry, but expects continued year-over-year revenue and adjusted EBITDA growth for the next two quarters [9][23] - The company has not seen material changes in demand due to current tariffs, although there is some cost inflation linked to tariffs [22][23] Company Strategy and Development Direction - The company is focused on client satisfaction, integration of scientific services, and site optimization plans to improve operational efficiency and margins [7][10] - A revised RMS site optimization plan is expected to yield annual cost savings of $6 million to $7 million, with completion anticipated by March 2026 [11][12] - The company is adapting to FDA announcements regarding drug development and animal testing, positioning itself to leverage new methodologies [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the level of quoting and awards in the DSA segment, expecting improvements in margins starting in Q3 of fiscal 2025 [49][86] - The company is monitoring NIH funding impacts but has not seen significant changes in business yet [52][54] - Management remains confident in the company's ability to navigate geopolitical and macroeconomic uncertainties while creating value for clients and shareholders [23][24] Other Important Information - The company plans to hold an Investor Day on May 29 to further discuss its strategic plan and focus on client excellence [87] - The company has made significant investments in acquisitions and site optimizations to prepare for future growth [7][10] Q&A Session Summary Question: Changes in marketing strategies post-FDA announcement - Management has integrated new services into their discovery sales process and is seeing some growth, though not as rapid as expected [35][36] Question: Focus areas in the revised RMS optimization plan - The revised plan aims to improve efficiencies and reduce costs, with a focus on maximizing existing resources rather than expanding capacity [40][41] Question: Current demand trends and quoting activity - Management reported a positive start to the current quarter, with strong quoting and closing activity [46][49] Question: Impact of NIH funding on customer mix - There has been no dramatic impact from NIH funding yet, with some customers increasing orders while others have reduced them [52][54] Question: DSA margin improvement timeline - Management expects to see benefits from identified margin improvement areas sooner rather than later, with some improvements already noted [66][68]

Core Viewpoint - Inotiv, Inc. reported a revenue increase of 4.4% in Q2 FY 2025 compared to the same period last year, driven primarily by growth in Research Models and Services (RMS) revenue, despite a decline in Discovery and Safety Assessment (DSA) revenue [1][6][8]. Financial Performance - Q2 FY 2025 revenue was $124.3 million, up from $119.0 million in Q2 FY 2024, with RMS revenue increasing by $6.6 million (9.1%) and DSA revenue decreasing by $1.3 million (2.8%) [2][6][8]. - Year-to-date (YTD) FY 2025 revenue decreased by 4.1% to $244.2 million compared to $254.5 million in YTD FY 2024, attributed to a $7.2 million (4.4%) decline in RMS revenue and a $3.2 million (3.5%) decline in DSA revenue [10][13]. - The consolidated net loss for Q2 FY 2025 was $14.9 million (12.0% of total revenue), significantly improved from a net loss of $48.1 million (40.4% of total revenue) in Q2 FY 2024 [6][13]. - Adjusted EBITDA for Q2 FY 2025 was $8.0 million (6.4% of total revenue), compared to $3.1 million (2.6% of total revenue) in Q2 FY 2024 [6][13]. Segment Performance - DSA revenue for Q2 FY 2025 was $45.3 million, down from $46.6 million in Q2 FY 2024, while RMS revenue was $79.0 million, up from $72.4 million [2][33]. - The operating loss for Q2 FY 2025 was $2.9 million, a significant reduction from an operating loss of $43.1 million in Q2 FY 2024, primarily due to improved RMS performance [9][11]. Operational Insights - The company is focusing on optimizing its RMS sites in North America to align better with client needs and enhance client satisfaction [3]. - Management is attentive to external factors such as tariffs and R&D funding levels, with proactive strategies in place to mitigate current tariff impacts [3]. Cash Flow and Debt - Cash and cash equivalents stood at $19.3 million as of March 31, 2025, down from $21.4 million at the end of September 2024 [12]. - Total debt as of March 31, 2025, was $399.5 million, with no borrowings on the company's $15.0 million revolving credit facility [12].

Financial Performance - Q1 2025 - Revenue decreased by 2.7% year-over-year to $984.2 million, with an organic revenue decline of 1.8%[24, 45] - GAAP EPS decreased by 61.5% year-over-year to $0.50, while non-GAAP EPS increased by 3.1% to $2.34[26, 45] - The company completed the repurchase of $350 million in common stock during 1Q25[47] - Free cash flow increased to $112.4 million compared to $50.7 million in 1Q24[48] Segment Performance - Q1 2025 - Discovery and Safety Assessment (DSA) revenue decreased by 2.1% to $592.6 million, with an organic decline of 1.4%[28] - Research Models and Services (RMS) revenue decreased by 3.5% to $213.1 million, with an organic decline of 2.5%[35] - Manufacturing Solutions revenue decreased by 3.6% to $178.5 million, with an organic decline of 2.2%[38] Updated 2025 Guidance - The company revised its 2025 revenue growth guidance to a decline of 5.5%-3.5% reported and a decline of 4.5%-2.5% organic[27, 51] - GAAP EPS estimate is $4.35-$4.85, and non-GAAP EPS estimate is $9.30-$9.80[27] - The company expects approximately flat organic revenue growth for RMS and approximately flat revenue for Manufacturing, while DSA organic revenue is expected to decline in the mid-single-digit range[52] NAMs (New Approach Methodologies) - CRL generated approximately $200 million in annual DSA revenue from NAMs, with the majority in discovery[13] - Chronic NHP studies longer than 3 months for mAbs represented approximately $50 million of the company's annual revenue[18] - Large Molecule accounted for ~25% of CRL safety assessment revenue mix in 2024, with mAbs accounting for ~10% and other biologics accounting for ~15%[20]

Recognized in both pre-and post-approval pharmacovigilance operationsDURHAM, N.C., May 01, 2025 (GLOBE NEWSWIRE) -- Fortrea (Nasdaq: FTRE), a leading global contract research organization (CRO), today announced it has been recognized as a “Leader” for pharmacovigilance (PV) operations by Everest Group in its annual Pharmacovigilance Operations PEAK Matrix® Assessment 2025. Fortrea’s top position was recognized in both pre-and post-approval PV operations in Everest Group’s proprietary framework, which assess ...