Core Insights - Inotiv, Inc. (NOTV) shares surged over 23% in after-hours trading following the release of preliminary fiscal fourth quarter and full year results for the period ending September 30, 2025 [1] Financial Performance - Q4 2025 revenue is projected to be between $137.5 million and $138.5 million, marking a year-over-year increase of approximately 6% from $130.4 million in Q4 2024 [1][2] - For the full fiscal year 2025, revenue is expected to be between $512.5 million and $513.5 million, reflecting a 4.5% growth compared to $490.7 million in fiscal 2024 [2] - The Discovery and Safety Assessment (DSA) services experienced significant growth, increasing by 60% year-over-year in Q4 [2] Operational Metrics - The company reported a book-to-bill ratio of approximately 1.08x for Q4 and 1.05x for FY2025, with a backlog of $138 million at the end of September 2025 [2] - CEO Robert Leasure Jr. emphasized the company's progress towards financial goals set during the May investor day, highlighting sequential growth in contract awards and enhanced revenue visibility [3] Upcoming Events - Inotiv is scheduled to present at the Jefferies Global Healthcare Conference in London on November 18, 2025, where further updates are anticipated [3] - Final audited results for Q4 and FY2025 will be reported in early December [3] Stock Performance - Over the past year, NOTV shares have traded between $0.65 and $6.48, closing at $0.68 before rising to $0.84 in after-hours trading, reflecting a 23.53% increase [4]

Core Insights - Several small-cap biotech and therapeutics companies experienced significant gains in after-hours trading, driven by earnings updates, financial guidance, and regulatory developments [1] Company Summaries - Inotiv, Inc. (NOTV) saw a 36.61% increase in after-hours trading to $0.94, recovering from a 33.20% decline at the close, following preliminary Q4 revenue expectations of $137.5 million to $138.5 million and full-year revenue projections of $512.5 million to $513.5 million [2] - Applied Therapeutics, Inc. (APLT) rose 16.89% to $0.33 after a 30.19% gain at the close, with investors reacting positively to a narrower Q3 net loss of $19.0 million, or $0.13 per share, compared to a $68.6 million loss, or $0.48 per share, in the same quarter last year [3] - Alumis Inc. (ALMS) advanced 7.09% to $5.97, despite reporting a Q3 net loss of $110.8 million, wider than the $93.1 million loss in the prior year, with $2.1 million in collaboration income potentially boosting investor confidence [4] - TELA Bio, Inc. (TELA) increased 7.89% to $1.23 after a 14.08% gain at the close, reporting a reduced Q3 net loss of $8.6 million compared to $10.4 million a year earlier, with revenue growth of 9% to $20.7 million and revised 2025 guidance projecting at least 16% revenue growth over 2024 [5] - Corcept Therapeutics Inc. (CORT) gained 4.90% to $78.80, reflecting continued investor interest despite no specific news released [6] - BioRestorative Therapies, Inc. (BRTX) jumped 8.06% to $1.34, rebounding from a 6.77% decline at the close, following the announcement of a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application pathway for its BRTX-100 program [7]

Financial Results - Inotiv, Inc. announced preliminary unaudited financial results for Q4 and fiscal year ended September 30, 2025[4] - The press release detailing financial results is available in the Investors section of the Company's website[4] Upcoming Events - The presentation by CEO Robert Leasure at the Jefferies Global Healthcare Conference is scheduled for November 18, 2025[4]

Core Insights - Inotiv, Inc. anticipates fourth quarter 2025 revenue between $137.5 million and $138.5 million, reflecting a year-over-year improvement and aligning with expectations [1][2] - The company expects full year 2025 revenue to be in the range of $512.5 million to $513.5 million [1][6] - The Discovery and Safety Assessment (DSA) services business experienced a 60% growth compared to the same period last year, with a book-to-bill ratio of approximately 1.08x for Q4 FY 2025 [2][6] Preliminary Financial Results - Preliminary expected revenue for Q4 FY 2025 is projected at $137.5 million to $138.5 million [1][6] - Full year 2025 revenue is anticipated to be between $512.5 million and $513.5 million [1][6] - DSA backlog is expected to be approximately $138.0 million as of September 30, 2025, an increase from $129.9 million a year prior [6] Company Presentation - Robert Leasure Jr., President and CEO, will present at the Jefferies Global Healthcare Conference on November 18, 2025, at 11:00 AM GMT [4] - The presentation will be accessible via a live webcast, with a replay available on the company's website [4] Company Overview - Inotiv, Inc. is a leading contract research organization focused on nonclinical and analytical drug discovery and development services [5][7] - The company aims to enhance efficiency, improve data quality, and reduce costs associated with bringing new drugs and medical devices to market [5]

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Verrica Pharmaceuticals, Inc. (NASDAQ: VRCA), urging shareholders to contact the firm to discuss their rights and possible legal actions [1][2]. Group 1: Shareholder Rights and Legal Options - Long-term shareholders of Verrica may seek corporate governance reforms, the return of funds to the company, court-approved financial incentive awards, or other relief and benefits [2][3]. - Shareholder involvement is emphasized as a means to improve company policies, practices, and oversight mechanisms, ultimately enhancing shareholder value [3]. Group 2: Firm's Background and Services - Halper Sadeh LLC represents investors globally who have experienced securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors [4].

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Inotiv, Inc., urging shareholders to contact the firm to discuss their rights and possible legal actions [1][2]. Group 1: Shareholder Rights and Legal Options - Long-term shareholders of Inotiv may seek corporate governance reforms, the return of funds to the company, court-approved financial incentive awards, or other relief and benefits [2][3]. - Shareholder involvement is emphasized as a means to improve company policies and practices, enhancing transparency and accountability, which can ultimately increase shareholder value [3]. Group 2: Legal Representation and Contingency Fees - Halper Sadeh LLC represents investors globally who have experienced securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors [4]. - The firm operates on a contingent fee basis, meaning shareholders would not incur out-of-pocket legal fees or expenses [2].

Core Insights - Inotiv, Inc. is actively participating in several upcoming healthcare conferences, showcasing its commitment to engaging with institutional investors and stakeholders in the healthcare sector [1][2]. Group 1: Conference Participation - Inotiv's President and CEO, Robert Leasure Jr., and CFO, Beth Taylor, will represent the company at the UBS Global Healthcare Conference on November 10-11, 2025, in Palm Beach Gardens, FL, focusing on one-on-one institutional investor meetings [2]. - The company will also present at the Jefferies Global Healthcare Conference in London on November 18, 2025, at 4:00 PM GMT/11:00 AM ET, which will include a presentation and one-on-one meetings [2]. - Additionally, Beth Taylor will participate in the Craig-Hallum Alpha Select Conference in New York, NY, on November 18, 2025, which will also be focused on one-on-one institutional investor meetings [2]. Group 2: 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 services aim to enhance the efficiency and data quality of drug and medical device development while reducing associated costs [3]. - Inotiv is dedicated to supporting research and development objectives, contributing to the advancement of healthcare and safety [3].

Group 1 - The company is responsible for the development of transcript-related projects [1] - The company publishes thousands of quarterly earnings calls per quarter and is expanding its coverage [1] - The purpose of the profile is to share new transcript-related developments with readers [1]

Summary of Inotiv FY Conference Call - September 10, 2025 Company Overview - **Company**: Inotiv (NasdaqCM:NOTV) - **Industry**: Contract Research Organization (CRO) - **Business Focus**: Preclinical market, from drug discovery to first in human through the IND phase - **Current Revenue**: Approximately $500 million, up from $20 million over the past seven to eight years [3][4] Key Market Segments - **Research Models Services (RMS)**: Approximately two-thirds of the business - **Discovery and Safety Assessment (DSA)**: Remaining one-third of the business - **Addressable Market Size**: Estimated at $25 billion, with Inotiv being a small player [4][5] Strategic Developments - **Integration and Optimization**: Focus on integrating services and optimizing operations to enhance customer value and speed of delivery [6][9] - **Facility Optimization**: Reduced facilities by 30-35%, closing 10-11 locations while maintaining capacity [9] - **Transportation System**: Developed a transportation system for animal transport across the U.S. [4] Customer Focus - **Target Market**: Small to mid-sized pharmaceutical companies, addressing their unique needs [7] - **Customer Satisfaction Metrics**: Improved tracking of project timelines and customer complaints to enhance service delivery [10][18] Financial Performance - **Revenue Growth**: - RMS revenue increased by 34% year-over-year - DSA revenue increased by 8.9% year-over-year [23] - DSA business reported 25% year-over-year award growth in recent quarters [17] - **EBITDA Goals**: Aiming to return to $70-100 million in annual EBITDA, with a focus on improving quality and reducing discounting [25][28] Future Outlook - **Growth Strategy**: Continued focus on DSA as a key growth driver, with expectations of 10% volume growth to achieve financial targets [28] - **Market Positioning**: Emphasis on building a full-service DSA organization while primarily focusing on preclinical and early-stage CRO services [30][31] - **Investment in Infrastructure**: Significant investments in IT and compliance to enhance operational efficiency and regulatory adherence [21][22] Additional Insights - **NHP Business**: Noted volatility in the Non-Human Primate (NHP) market, with efforts to diversify customer and supply bases [14][19] - **Regulatory Compliance**: Enhanced compliance measures critical to operations in a heavily regulated industry [21] - **Management Philosophy**: Emphasis on embracing challenges to drive improvement and adaptability within the organization [22] This summary encapsulates the key points discussed during the Inotiv FY Conference Call, highlighting the company's growth trajectory, strategic initiatives, and future outlook in the CRO industry.

Summary of Conference Call Company Overview - The company is a relatively young preclinical Contract Research Organization (CRO) that has grown through the acquisition of 14 companies over the past six to seven years, aiming to provide a full-service suite from discovery to first-in-human testing, primarily focusing on preclinical services [3][4] Key Business Segments - The company operates two main business segments: - **DSA (Discovery Services and Assessment)**: This segment has shown significant growth, with a reported 27% year-over-year increase in awards for Q2 and a further 25% increase in Q3 [5][6] - **RMS (Research Models and Services)**: This segment has stabilized after optimizing sites and reducing costs by 35%, while maintaining capacity [4][5] Financial Performance - The DSA business has seen a notable increase in backlog and sales, with a conversion rate improvement and margin enhancement [5][6] - The company is cautiously optimistic about future trends, although the macro environment remains uncertain [6] Market Dynamics - The NHP (Non-Human Primate) market has undergone significant changes, with the U.S. importing about half of what it did three years ago, primarily due to restrictions from exporting countries [12][14] - The company has diversified its sources for NHPs and is investing in domestic breeding to adapt to market changes [16][17] Regulatory and Political Landscape - The company has observed that regulatory headlines often lead to stock volatility, but actual changes take time to implement [33][34] - NIH funding changes have impacted some contracts, but the overall effect is not expected to be material [35][36] Operational Improvements - The company has focused on enhancing customer service and operational efficiency, including on-time delivery and accurate invoicing, which are critical for maintaining client relationships [21][22] - Investments in veterinary science and a strong scientific team have been made to improve service offerings [19][20] Cybersecurity Incident - The company experienced a significant cyberattack, which has been addressed through backup programs and operational continuity measures [51][55] - Communication with customers regarding the incident has been prioritized to maintain trust [57] Future Outlook - The company does not anticipate needing market growth to increase sales, as it has the capacity to grow independently [42][45] - A $350 million shelf registration has been extended to keep financing options open, with plans to address the balance sheet in the near future [47][49] Conclusion - The company is navigating a complex market environment with a focus on operational improvements, regulatory challenges, and strategic growth in its DSA and RMS segments. The emphasis on customer service and scientific expertise positions the company well for future opportunities despite current market uncertainties [66]