Inotiv, Inc. · NASDAQ:NOTV
Inotiv — Investor Day (May 2025)
47 slides from Inotiv's investor day presentation, May 29, 2025
Slide 1: May 2025 Investor Day Meeting with Management
May 2025 Investor Day Meeting with Management
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements that are subject to risks and uncertainties including, but not limited to, statements regarding our intent, belief or current expectations with respect to (i) our strategic plans and future financial results; (ii) trend
Slide 3: Opening Remarks
Opening Remarks Bob Leasure CEO, President and Director
Slide 4: Company Overview
Company Overview • Inotiv, Inc. is a leading contract research organization (“CRO”) dedicated to providing drug discovery and development services primarily to the pharmaceutical and medical device industries • We provide a comprehensive suite of high research-quality science, models, diets and serv
Slide 5: The Evolving Preclinical Industry and Current Challenges
The Evolving Preclinical Industry and Current Challenges Adrian Hardy, Chief Commercial Officer & John Sagartz, Chief Strategy Officer
Slide 6: Evolving Preclinical Industry and Current Challenges
Evolving Preclinical Industry and Current Challenges • Tariffs • NIH funding • New approach methodologies (NAMs) 6
Slide 7: Trade Tariffs
Trade Tariffs • Uncertainty as to whether US-imposed trade tariffs, and any retaliatory actions from trade partners, could impact pricing and supply chain – likely to become clear over time on a country-by-country basis • Potential impacts for Inotiv are both direct and indirect • Direct impacts – c
Slide 8: NIH Funding
NIH Funding • NIH is the largest public funder of biomedical research globally, with a current annual budget of ~$48 billion • The US administration has proposed a cut to the NIH 2026 budget of ~40%, approximately a quarter of which would be anticipated to come from capping grant funding for indirec
Slide 9: FDA Recent Announcement
FDA Recent Announcement • April 10, 2025, the FDA announced efforts to reduce, refine and replace certain animal testing • FDA will consider, that with certain well-characterized therapeutic candidates such as monoclonal antibodies (mABs), fast track review may be given to products characterized usi
Slide 10: Inotiv and NAMs
Inotiv and NAMs • “NAMs” > New Approach Methodologies > “Non-Animal Methodologies” • Inotiv’s NAMs capabilities > Computational toxicology > Genetic toxicology in bacteria and mammalian cells > Cell culture techniques (primary and cell lines) > Access to procured and curated healthy and diseased hum
Slide 11: NAMs Example in Supporting 3R's (Reduce and Refine)
NAMs Example in Supporting 3R’s (Reduce and Refine) • ILSI-HESI alternatives to carcinogenicity > Initiated in 1996 with the widespread capability of generating knock-out and transgenic mice > Industry consortium consisting of regulators, pharmaceutical companies, CROs and animal suppliers > Goal: D
Slide 12: Reduce and Refine: Mouse Carcinogenicity
Reduce and Refine: Mouse Carcinogenicity • Studies conducted over several years by numerous sponsors, evaluating several mechanisms of cancer risk assessment • p53+/-, TG.AC, Tg.rasH2, neonatal mouse assay • Outcome > Regulatory acceptance of alternative models, especially p53+/- and Tg.rasH2 > With
Slide 13: Refine and/or Replace: Skin Sensitization Assay
Refine and/or Replace: Skin Sensitization Assay • Historically, relied on animal models, especially guinea pigs, to evaluate immune-mediated skin responses • The local lymph node assay, a mouse-based test, became a dominant method for assessing skin sensitization. Involves injecting the test chemica
Slide 14: Skin Sensitization Assays
Skin Sensitization Assays • Integrated Testing Strategies and Defined Approaches • To improve the accuracy and reliability of skin sensitization assessments, integrated testing strategies that combine multiple assays, including in vivo and in vitro methods, are now in use • Defined Approaches (DAs)
Slide 15: Vision of a Possible NAMs Future
Vision of a Possible NAMs Future • Industry has been developing NAMs technologies for decades • Already made substantial progress in supplementing the science, and refining and reducing the use of animals, in drug development • It took over twenty years to almost completely replace the use of animal
Slide 16: Building Inotiv for the Future
Building Inotiv for the Future Bob Leasure, CEO, President and Director
Slide 17: Filling the Gap as a Leading, Middle-Market CRO
Filling the Gap as a Leading, Middle-Market CRO 17 Large CROs Annual Revenue < $20M per entity $491M 1 $ billions Service Orientation One-off preclinical services Comprehensive preclinical services, research models, and some clinical services Primarily clinical services; some preclinical services Cl
Slide 18: DSA Strategy
DSA Strategy • Inotiv acquired multiple niche, high science and technology providers to create an integrated offering • The breadth of what Inotiv has assembled allows for increasingly deep partnerships, as Inotiv can work across multiple therapeutic areas and drug modalities • Relentless focus on q
Slide 19: RMS Strategy
RMS Strategy • The business Inotiv acquired in RMS had a mixed reputation as a client-centric provider, with inconsistent quality and compliance challenges in one facility • Inotiv has consistently invested in raising quality, and raising the bar on compliance, since acquisition, while maintaining t
Slide 20: Strategic Evolution of Inotiv
Strategic Evolution of Inotiv • Phase I: Acquisition and Growth (2018-2023) > M&A activity drove development of a full-service drug discovery and development CRO, and secured critical supply chains > Initiated organic investments to create capacity for growth • Phase II: Optimization & Integration (
Slide 21: Phase I: Acquisition and Growth
Phase I: Acquisition and Growth Building a Full-Service CRO
Slide 22: Acquisition & Growth: Building a Full-Service CRO
Acquisition & Growth: Building a Full-Service CRO • Strengthen management team • Accretive, client-driven acquisitions • Organic growth • Comprehensive breadth of services 22
Slide 23: Experienced Management Team
Robert Leasure, Jr. Chief Executive Officer, President and Director Beth Taylor Executive Vice President, Chief Financial Officer Past Experience John Sagartz, DVM, PHD Chief Strategy Officer and Director Jeff Krupp Chief Human Resources Officer Greg Beattie Chief Operating Officer, DSA Lizanne Mull
Slide 24: Successful Acquisition Strategy
Successful Acquisition Strategy (14 in 5 years) $26.3 $43.6 $60.5 $89.6 $547.7 FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Capabilities Added: • Medical Device Assessment • Surgical Specialty Revenue ($millions) Capabilities Added: • Genetic Toxicology • Specialty Histology and Pathology • Drug Discover
Slide 25: Focused Organic Growth
Focused Organic Growth • Capital investments in existing DSA facilities increased annual revenue capacity by >$65m > General toxicology, genetic toxicology, safety pharmacology, biotherapeutics, discovery services, medical devices Targeted organic investments in internal capabilities and growth capa
Slide 26: Comprehensive Breadth of Services
Comprehensive Breadth of Services Computational Tox/ Toxicogenomics Pharmacology Drug Metabolism Safety Pharmacology General Tox Genetic Tox Bioanalysis Histology/Pathology DART Research Models and Services Archiving Clinical DevelopmentDiscovery Preclinical Development Lead Selection Optimization I
Slide 27: Phase II: Optimization & Integration
Phase II: Optimization & Integration Building One Inotiv
Slide 28: Optimization & Integration: Building One Inotiv
Optimization & Integration: Building One Inotiv • Site optimization & capacity utilization • In-sourcing transportation • Reduction of DSA outsourced 3rd party spend • Evolution of the NHP business • Enterprise study management • Strengthening commercial organization • Investments in strategic IT in
Slide 29: RMS Animal Facility Footprint Optimization
RMS Animal Facility Footprint Optimization 29 • Multi-year program to consolidate the number of RMS small animal production facilities • Increase operating efficiency and drive higher revenues per facility • Optimize capital expenditures to enhance quality and animal welfare in reduced number of fac
Slide 30: Insourcing Transportation
Insourcing Transportation • Route optimization and client satisfaction improvements were initiated in 2022 with our previous outsourced provider • In 2024 majority of North American transportation infrastructure was in-sourced to achieve further improvements • Internal logistics experts focus on rou
Slide 31: Reduction of DSA Outsourced 3rd Party Spend
Reduction of DSA Outsourced 3rd Party Spend • As Inotiv increased the depth and breadth of preclinical and discovery services it offers, outsourcing spend was reduced in favor of in- house capabilities • In addition to reducing third-party spend, we also experienced an increasing percentage of proje
Slide 32: Evolution of NHP Business
Evolution of NHP Business FY 2022 – FY 2025 0 5 10 15 20 25 30 35 FY 2022 FY 2023 FY 2024 FY 2025 E NA NHP Colony Management Revenue • Increasing service revenue/colony management (boarding and breeding) • Diversification of client base • Diversification of supplier base • Increasing long-term reocc
Slide 33: Managing Complex Drug Development Programs
Managing Complex Drug Development Programs • Assembled and integrated the people, processes and systems to deliver a seamless Inotiv experience for clients • Professional program management team providing oversight for complex projects through entire development lifecycle • Sophisticated project man
Slide 34: Commercial Organization
Commercial Organization • Inotiv brand integrated across all DSA acquisitions created high-science, high-service organization • New sales team for discovery launched in 2023 with special expertise in complex pharmacological discovery models • New commercial leadership in mid- 2024 integrated sales a
Slide 35: Enabling Integration with Strategic Investments
Enabling Integration with Strategic Investments • Enhancing Client Relationships > Customer Relationship Management (CRM) > Client Invoicing > Quality Management > Archiving • Operating Efficiency > Preclinical Data Collection > Enterprise Study/Project Management > Electronic Lab Notebooks > NHP Ma
Slide 36: Enhanced Compliance Program
Enhanced Compliance Program Continuous Improvement • Appointed a Chief Compliance Officer and Compliance Committee responsible for overseeing the Company’s compliance, particularly with respect to animal welfare and environmental requirements • Developed and implemented a Nationwide Compliance Plan
Slide 37: Phase III: Expansion Building on the Platform
Phase III: Expansion Building on the Platform
Slide 38: Expansion: Building on the Platform
Expansion: Building on the Platform • Strategic focus to drive value • Expanding margins • DSA strategy • RMS strategy • Opportunistic M&A > Client driven > Accretive > Additional shareholder value 38
Slide 39: Strategic Focus to Drive Value
Strategic Focus to Drive Value Drive organic revenue growth with enhancements in commercial execution and client satisfaction Exceed client expectations with high scientific touch and speed of project execution creating up/cross-selling opportunities to expand share of wallet Increase margins throug
Slide 40: DSA Strategy
DSA Strategy • Inotiv acquired multiple niche, high science and technology providers to create an integrated offering • The breadth of what Inotiv has assembled allows for increasingly deep partnerships, as Inotiv can work across multiple therapeutic areas and drug modalities • Relentless focus on q
Slide 41: RMS Strategy
RMS Strategy • The business Inotiv acquired in RMS had a mixed reputation as a client-centric provider, with inconsistent quality and compliance challenges in one facility • Inotiv has consistently invested in raising quality, and raising the bar on compliance, since acquisition, while maintaining t
Slide 42: Financial Metrics & Trends
Financial Metrics & Trends Beth Taylor Executive Vice President and Chief Financial Officer
Slide 43: Agenda
Agenda • FY Q2 2025 financial results • Margin bridge • Current capital structure 43
Slide 44: Q2 2025 Financial Results Overview
Q2 2025 Financial Results Overview 44 Q2’2025 Revenue 64% RMS 36% DSA Total Rev: $124.3M +4.4% yoy RMS • NHP client base expanded to support consistent revenue stream • Colony management sales expected to ↑ for FY2025 • Next phase of site optimization leading to $6M-$7M annual cost savings on track
Slide 45: AEBITDA Goals and Bridge
AEBITDA Goals and Bridge 45 Note: Adjusted EBITDA and Adjusted EBITDA margin goals are provided on a non-GAAP basis. The calculation of Adjusted EBITDA is consistent with the Adjusted EBITDA reported in our quarterly earnings. The Company cannot reconcile this guidance to expected net income or expe
Slide 46: Capital Structure
Capital Structure • Senior secured term loans > $275.0 million par > Interest rate SOFR + 6.75% > Mature November 2026 > Current operating plan forecasts compliance with covenants • Convertible senior notes > $133.7 million par > Coupon rate 3.25% > Mature October 2027 46 • Second lien notes > $22.6
Slide 47: Company Contact
Company Contact: Inotiv, Inc. Beth A. Taylor, CFO investors@inotiv.com Investor Contact: LifeSci Advisors Steven Halper 646-876-6455 SHalper@lifesciadvisors.com For more information, please visit us at https://www.inotiv.com/