Inotiv, Inc.

— Third quarter fiscal 2024 revenue down 32.8% to $105.8 million — Year-to-date fiscal 2024 revenue down 16.5% to $360.3 million — Conclusion of certain government investigations — Site optimization projects complete — Conference call begins today at 4:30 pm ET WEST LAFAYETTE, Ind., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Inotiv, Inc. (Nasdaq: NOTV) (the “Company”), 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 financial results for the three months (“Q3 FY 2024”) and nine months ("YTD FY 2024") ended June 30, 2024. Revenue by Segment (in millions of USD) Three Months Ended June 30, 2024 % change Nine Months Ended June 30, 2024 % change 2024 2023 2024 2023 (unaudited) (unaudited) (unaudited) (unaudited) DSA (Discovery & Safety Assessment) $44.2 $46.8 (5.6)% $135.5 $134.9 0.4%RMS (Research Models & Services) $61.6 $110.7 (44.4)% $224.8 $296.8 (24.3)%Total $105.8 $157.5 (32.8)% $360.3 $431.7 (16.5)% Management Commentary Robert Leasure Jr., President and Chief Executive Officer, commented, “The third quarter was productive for Inotiv; however, the period was not without challenges. Our financial results in Q3 were negatively impacted again, much like Q2, due to lower NHP demand and pricing. However, we were able to accomplish some significant milestones and see signs of improvements going into the end of 2024 and into 2025. We were pleased to see the conclusion of certain open government investigations. We are seeing signs of recovery for the NHP business, we are beginning to see growth in segments of our U.S, European and U.K., RMS businesses and portions of our DSA business. We have completed additional site optimization, integration and transportation initiatives which continue to provide efficiencies and expense reductions while improving service and delivery. We have faced some unexpected challenges over the past two years, but we have made progress and have confidence in the future for our industry, our company, and the investments we have made to prepare ourselves for the future. We want to position ourselves so we will not be dependent solely on a market recovery to improve our results of operations and cash flow. Our results for Q3 show some trends towards that momentum." Financial Highlights Q3 FY 2024 Highlights Revenue was $105.8 million in Q3 FY 2024 as compared to $157.5 million during the three months ended June 30, 2023 (“Q3 FY 2023”), driven primarily by a decrease of $49.1 million, or 44.4%, in Research Models and Services (“RMS”) revenue and a $2.5 million, or 5.4%, decrease in Discovery and Safety Assessment ("DSA") revenue.Consolidated net loss for Q3 FY 2024 was $26.1 million, or 24.7% of total revenue, compared to consolidated net income of $0.4 million, or 0.2% of total revenue, in Q3 FY 2023.Adjusted EBITDA1 in Q3 FY 2024 was $0.1 million, or 0.1% of total revenue, compared to $30.5 million, or 19.4% of total revenue, in Q3 FY 2023.Book-to-bill ratio for Q3 FY 2024 was 0.94x for the DSA services business.DSA backlog was $139.4 million at June 30, 2024, down from $149.1 million at June 30, 2023, and down from $142.1 million at March 31, 2024. YTD FY 2024 Highlights Revenue was $360.3 million during YTD FY 2024 compared to $431.7 million during the nine months ended June 30, 2023 ("YTD FY 2023"), primarily driven by a $72.0 million, or 24.3%, decrease in RMS revenue.Consolidated net loss for YTD FY 2024 was $90.0 million, or 25.0% of total revenue, compared to consolidated net loss of $96.2 million, or 22.3% of total revenue, for YTD FY 2023. Consolidated net loss for YTD FY 2024 included a $28.5 million charge related to the Resolution Agreement (the “Resolution Agreement”) the Company and its related entities entered into with the U.S. Department of Justice ("DOJ") and the United States Attorney’s Office for the Western District of Virginia (“USAO-WDV”) and the Plea Agreement (the “Plea Agreement”) Envigo RMS, LLC and Envigo Global Services, Inc. entered into with the DOJ and the USAO-WDV. Each of the Resolution Agreement and the Plea Agreement were entered into on June 3, 2024 in connection with the resolution of a previously-announced criminal investigation into the Company’s shuttered canine breeding facility located in Cumberland, Virginia. Consolidated net loss for YTD FY 2023 included a $66.4 million non-cash goodwill impairment charge related to the RMS segment.Adjusted EBITDA1 in YTD FY 2024 was $12.8 million, or 3.6% of total revenue, compared to $42.1 million, or 9.8% of total revenue, in YTD FY 2023.Book-to-bill ratio for YTD FY 2024 was 1.06x for the DSA services business. 1 This is a non-GAAP financial measure. Refer to “Non-GAAP to GAAP Reconciliation” in this release for further information. DSA and RMS Highlights On June 2, 2024, the Company, certain subsidiaries of the Company and the lenders party thereto entered into a Fifth Amendment (“Fifth Amendment”) to the Credit Agreement. The Fifth Amendment, among other changes, permits charges or expenses attributable to or related to the Resolution Agreement and the Plea Agreement to be added back to the Company’s Consolidated EBITDA in an amount up to $28.5 million, of which the Company paid $6.5 million during Q3 FY 2024; excludes any direct effects to the Company resulting from the Resolution Agreement and the Plea Agreement from being deemed a material adverse effect under the Credit Agreement; permits liens on the Company and certain subsidiaries in favor of the DOJ in connection with the Resolution Agreement and the Plea Agreement; provides that certain uncured or unwaived breaches of the terms and conditions of the Resolution Agreement and the Plea Agreement shall be considered an event of default under the Credit Agreement; and enables the lenders to cause, at their discretion, material foreign subsidiaries to be joined as guarantors of the Company’s obligations under the Credit Agreement.On June 3, 2024, Inotiv, Inc. announced that it had reached agreement with the DOJ to resolve a previously-announced criminal investigation into its shuttered canine breeding facility located in Cumberland, Virginia, which was operated originally by Envigo RMS, LLC, an entity acquired by the Company in November 2021.The Company continued to execute on its site optimization plan for its Blackthorn, U.K. site, which the Company is leasing back until its operations are relocated to its Hillcrest, U.K. site. The relocation of operating activities from Blackthorn into its Hillcrest, U.K. site have been completed and the Company plans to exit the leased facility by the end of September 2024. Third Quarter Fiscal 2024 Financial Results (Three Months Ended June 30, 2024) Revenue decreased 32.8% to $105.8 million in Q3 FY 2024 as compared to $157.5 million in Q3 FY 2023. The lower total revenue in the second quarter was primarily driven by a $49.1 million decrease in RMS revenue and a $2.5 million decrease in DSA revenue. The decrease in RMS revenue was primarily due to the lower non-human primate ("NHP") related product and service revenue of $45.7 million mainly as a result of product volumes and pricing. Additionally, in Q3 FY 2024, there was a decrease of $3.0 million in RMS revenue as a result of the sale of our Israeli businesses in the fourth quarter of fiscal 2023. Operating loss was $20.8 million in Q3 FY 2024 as compared to operating income of $8.8 million in Q3 FY 2023. The higher total operating loss in Q3 FY 2024 was primarily due to the decrease in RMS revenue, partially offset by a decrease of $18.0 million in RMS cost of revenue1 and a decrease of $1.6 million in RMS operating expenses. The decrease in cost of revenue was primarily driven by a $17.3 million reduction of NHP-related cost of revenue1 and the impact of the sale of our Israeli businesses of $2.1 million. The decrease in operating expenses2 was primarily related to the $1.1 million decrease in provision of expected credit losses in addition to decreases in restructuring costs, severance, remediation costs and legal and professional fees, partially offset by the $2.0 million charge related to the Resolution and Plea Agreements. Cash and cash equivalents as of June 30, 2024, was $14.4 million and there were no borrowings on the Company’s $15.0 million revolving credit facility. Total debt, net of debt issuance costs, as of June 30, 2024, was $382.4 million. As of the date of this release, the Company has borrowings of $12.0 million outstanding under its revolving credit facility. On August 7, 2024, the Company entered into the Sixth Amendment (the "Sixth Amendment") to the Credit Agreement, which waives the financial covenant tests for the quarter ending June 30, 2024. Year-to-Date Fiscal 2024 Financial Results (Nine Months Ended June 30, 2024) Revenue decreased 16.5% to $360.3 million in YTD FY 2024 as compared to $431.7 million in YTD FY 2023. The lower total revenue in YTD FY 2024 was primarily driven by a $72.0 million decrease in RMS revenue due primarily to the negative impact of lower NHP sales of $58.2 million. Additionally, there was a decrease of $8.9 million in RMS revenue as a result of the sale of our Israeli businesses in the fourth quarter of fiscal 2023. The remaining decrease in RMS revenue was due primarily to decreases in small animal sales and RMS services in the U.S., partially offset by an increase in diets and bedding sales. Operating loss was $73.2 million in YTD FY 2024 as compared to $83.9 million in YTD FY 2023. The lower total operating loss in YTD FY 2024 was primarily due to a $66.4 million non-cash goodwill impairment charge related to our RMS segment in YTD FY 2023 that did not recur in YTD FY 2024, partially offset by the $28.5 million charge incurred during YTD FY 2024 related to the Resolution and Plea Agreements. Cash and cash equivalents of $14.4 million at June 30, 2024, compares to $35.5 million at September 30, 2023, the end of fiscal year 2023. Cash used by operating activities was $4.4 million for YTD FY 2024, which includes the June 3, 2024 payments of $6.5 million related to the Resolution and Plea Agreements, compared to cash provided by operating activities of $9.1 million for YTD FY 2023. For YTD FY 2024, capital expenditures totaled $17.0 million compared to $21.3 million for YTD FY 2023. 1Cost of revenue includes cost of services provided and cost of products sold excluding depreciation and amortization of intangible assets2Operating expenses include selling, general and administrative and other operating expenses excluding depreciation and amortization of intangible assets. Subsequent Events On July 23, 2024, the U.S. Attorney’s Office for the Southern District of Florida informed the Company that it was no longer investigating the Company or its subsidiaries with respect to their procurement of NHPs from foreign suppliers or NHP importation practices.On August 7, 2024, the Company, certain subsidiaries and the lenders party thereto entered into a Sixth Amendment to the Credit Agreement. The Sixth Amendment among other changes, waives the financial covenant tests set out under the Credit Agreement for the fiscal quarter ending June 30, 2024, establishes a new weekly liquidity reporting requirement to the lenders, and establishes a new minimum weekly liquidity requirement of $7.0 million for the weeks ending August 16, 2024, August 23, 2024 and August 30, 2024, $17.5 million for the weeks ending October 11, 2024, October 18, 2024 and October 25, 2024 and $10.0 million for each other week thereafter. Webcast and Conference Call Management will host a conference call on Thursday, August 8, 2024, at 4:30 pm ET to discuss third quarter fiscal 2024 results. Interested parties may participate in the call by dialing: (800) 225-9448 (Domestic)(203) 518-9708 (International)"Inotiv" (Conference ID) The live conference call webcast will be accessible in the Investors section of the Company’s web site and directly via the following link: https://viavid.webcasts.com/starthere.jsp?ei=1677787&tp_key=b286b1a375 For those who cannot listen to the live broadcast, an online replay will be available in the Investors section of Inotiv’s web site at: https://www.inotivco.com/investors/investor-information/. Non-GAAP to GAAP Reconciliation This press release contains financial measures that are not calculated in accordance with generally accepted accounting principles in the United States (GAAP), including Adjusted EBITDA and Adjusted EBITDA as a percentage of total revenue for the three and nine months ended June 30, 2024 and 2023 and selected business segment information for those periods. Adjusted EBITDA as reported herein refers to a financial measure that excludes from consolidated net loss, statements of operations line items interest expense and income tax benefit, as well as non-cash charges for depreciation and amortization, stock compensation expense, acquisition and integration costs, startup costs, restructuring costs, unrealized foreign exchange (gain) loss, amortization of inventory step up (gain) loss on disposition of assets, other unusual, third party costs, the charge in connection with the Resolution and Plea Agreements and goodwill impairment loss. The adjusted business segment information excludes from operating loss and unallocated corporate operating expenses for these same expenses. The Company believes that these non-GAAP measures provide useful information to investors. Among other things, they may help investors evaluate the Company’s ongoing operations. They can assist in making meaningful period-over-period comparisons and in identifying operating trends that would otherwise be masked or distorted by the items subject to the adjustments. Management uses these non-GAAP measures internally to evaluate the performance of the business, including to allocate resources. Investors should consider these non-GAAP measures as supplemental and in addition to, not as a substitute for or superior to, measures of financial performance prepared in accordance with GAAP.Management has chosen to provide this supplemental information to investors, analysts, and other interested parties to enable them to perform additional analyses of our results and to illustrate our results giving effect to the non-GAAP adjustments. Management strongly encourages investors to review the Company's condensed consolidated financial statements and publicly filed reports in their entirety and cautions investors that the non-GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures. About the Company Inotiv, Inc. is a leading contract research organization dedicated to providing nonclinical and analytical drug discovery and development services and research models and related products and services. The Company’s products and services focus on bringing new drugs and medical devices through the discovery and preclinical phases of development, all while increasing efficiency, improving data, and reducing the cost of taking new drugs and medical devices to market. Inotiv is committed to supporting discovery and development objectives as well as helping researchers realize the full potential of their critical research and development projects, all while working together to build a healthier and safer world. Further information about Inotiv can be found here: https://www.inotivco.com/. This release 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; (ii) trends in the demand for our services and products; (iii) trends in the industries that consume our services and products; (iv) market and company-specific impacts of NHP supply and demand matters; (v) compliance with the Resolution and Plea Agreements and the expected impacts on the Company related to the compliance plan and compliance monitor, and the expected amounts, timing and expense treatment of cash payments and other investments thereunder;(vi) our ability to service our outstanding indebtedness and to comply or regain compliance with financial covenants, including those established by the Sixth Amendment; (vii) our current and forecasted cash position; (viii) our ability to make capital expenditures, fund our operations and satisfy our obligations; (ix) our ability to manage recurring and unusual costs; (x) our ability to execute on our restructuring and site optimization plans and to realize the expected benefits related to such actions; (xi) our expectations regarding the volume of new bookings, pricing, operating income or losses and liquidity; (xii) our ability to effectively manage current expansion efforts or any future expansion or acquisition initiatives undertaken by us; (xiii) our ability to develop and build infrastructure and teams to manage growth and projects; (xiv) our ability to continue to retain and hire key talent; (xv) our ability to market our services and products under our corporate name and relevant brand names; (xvi) our ability to develop new services and products; (xvii) our ability to negotiate amendments to the Credit Agreement or obtain waivers related to the financial covenants defined within the Credit Agreement; and (xviii) the impact of public health emergencies on the economy, demand for our services and products and our operations, including the measures taken by governmental authorities to address such public health emergencies, which may precipitate or exacerbate other risks and/or uncertainties, including those detailed in the Company's filings with the U.S. Securities and Exchange Commission. Further discussion of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in our Annual Report on Form 10-K as filed on December 12, 2023, as well as other filings we make with the Securities and Exchange Commission. Company ContactInvestor RelationsInotiv, Inc.LifeSci AdvisorsBeth A. Taylor, Chief Financial OfficerBob Yedid(765) 497-8381(516) 428-8577btaylor@inotivco.combob@lifesciadvisors.com INOTIV, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except per share amounts)(Unaudited) Three Months EndedJune 30, Nine Months EndedJune 30, 2024 2023 2024 2023 Service revenue $54,364 $56,295 $165,188 $165,095 Product revenue 51,422 101,173 195,134 266,590 Total revenue $105,786 $157,468 $360,322 $431,685 Costs and expenses: Cost of services provided (excluding depreciation and amortization of intangible assets) 39,622 37,555 117,362 108,359 Cost of products sold (excluding depreciation and amortization of intangible assets) 45,083 60,520 161,728 189,709 Selling 5,030 4,780 15,781 14,045 General and administrative 16,782 25,705 56,505 82,296 Depreciation and amortization of intangible assets 14,119 13,864 42,524 40,117 Other operating expense 5,902 6,261 39,661 14,712 Goodwill impairment loss — — — 66,367 Operating (loss) income $(20,752) $8,783 $(73,239) $(83,920)Other (expense) income: Interest expense (12,116) (10,786) (34,568) (31,751)Other (expense) income (82) (12) 1,092 (1,345)Loss before income taxes $(32,950) $(2,015) $(106,715) $(117,016)Income tax benefit 6,863 2,380 16,721 20,820 Consolidated net (loss) income $(26,087) $365 $(89,994) $(96,196)Less: Net loss attributable to noncontrolling interests — (1,475) (440) (719)Net (loss) income attributable to common shareholders $(26,087) $1,840 $(89,554) $(95,477) (Loss) Income per common share Net (loss) income attributable to common shareholders: Basic $(1.00) $0.07 $(3.46) $(3.72)Diluted $(1.00) $0.07 $(3.46) $(3.72)Weighted-average number of common shares outstanding: Basic 25,993 25,726 25,862 25,690 Diluted 25,993 26,021 25,862 25,690 INOTIV, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share amounts)(Unaudited) June 30, September 30, 2024 2023 Assets Current assets: Cash and cash equivalents $14,434 $35,492 Trade receivables and contract assets, net of allowances for credit losses of $5,780 and $7,446, respectively 63,867 87,383 Inventories, net 38,684 56,102 Prepaid expenses and other current assets 32,248 33,408 Assets held for sale — 1,418 Total current assets 149,233 213,803 Property and equipment, net 189,703 191,068 Operating lease right-of-use assets, net 45,216 38,866 Goodwill 94,286 94,286 Other intangible assets, net 282,540 308,428 Other assets 13,610 10,079 Total assets $774,588 $856,530 Liabilities, shareholders' equity and noncontrolling interest Current liabilities: Accounts payable $28,325 $32,564 Accrued expenses and other current liabilities 28,064 25,776 Fees invoiced in advance 38,695 55,622 Current portion of long-term operating lease 11,439 10,282 Current portion of long-term debt 378,550 7,950 Total current liabilities 485,073 132,194 Long-term operating leases, net 35,899 29,614 Long-term debt, less current portion, net of debt issuance costs 3,897 369,795 Other long-term liabilities 34,912 6,373 Deferred tax liabilities, net 32,700 50,064 Total liabilities 592,481 588,040 Contingencies (Note 14) Shareholders’ equity and noncontrolling interest: Common shares, no par value: Authorized 74,000,000 shares at June 30, 2024 and at September 30, 2023; 26,006,460 issued and outstanding at June 30, 2024 and 25,777,169 at September 30, 2023 6,463 6,406 Additional paid-in capital 718,459 715,696 Accumulated deficit (543,272) (453,278)Accumulated other comprehensive income 457 330 Total equity attributable to common shareholders 182,107 269,154 Noncontrolling interest — (664)Total shareholders’ equity and noncontrolling interest 182,107 268,490 Total liabilities and shareholders’ equity and noncontrolling interest $774,588 $856,530 INOTIV, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands)(Unaudited) Nine Months EndedJune 30, 2024 2023 Operating activities: Consolidated net loss $(89,994) $(96,196)Adjustments to reconcile net loss to net cash provided by operating activities, net of acquisitions: Depreciation and amortization 42,524 40,117 Employee stock compensation expense 5,118 5,856 Changes in deferred taxes (17,407) (27,114)Provision for expected credit losses (1,282) 2,175 Amortization of debt issuance costs and original issue discount 2,575 2,339 Non-cash interest and accretion expense 5,553 4,608 Other non-cash operating activities (711) 2,486 Goodwill impairment loss — 66,367 Changes in operating assets and liabilities: Trade receivables and contract assets 24,876 13,047 Inventories 17,520 16,550 Prepaid expenses and other current assets 942 6,272 Operating lease right-of-use assets and liabilities, net 1,092 779 Accounts payable (4,931) 4,128 Accrued expenses and other current liabilities 2,254 (11,048)Fees invoiced in advance (17,017) (18,098)Other asset and liabilities, net 24,455 (3,148)Net cash (used in) provided by operating activities (4,433) 9,120 Investing activities: Capital expenditures (17,015) (21,324)Proceeds from sale of property and equipment 5,432 268 Net cash used in investing activities (11,583) (21,056) Financing activities: Payments on revolving credit facility — (21,000)Payments on senior term notes and delayed draw term loans (2,073) (2,070)Borrowings on revolving credit facility — 6,000 Borrowings on delayed draw term loan — 35,000 Other financing activities, net (2,816) (1,748)Net cash (used in) provided by financing activities (4,889) 16,182 Effect of exchange rate changes on cash and cash equivalents (153) 753 Net (decrease) increase in cash and cash equivalents (21,058) 4,999 Less: cash, cash equivalents, and restricted cash held for sale — (1,759)Cash, cash equivalents, and restricted cash at beginning of period 35,492 18,980 Cash, cash equivalents, and restricted cash at end of period, net of cash, cash equivalents and restricted cash held for sale $14,434 $22,220 Non-cash financing activity: Paid in kind debt issuance costs $— $1,363 Supplemental disclosure of cash flow information: Cash paid for interest $27,398 $26,889 Income taxes paid, net $1,517 $5,979 INOTIV, INC.RECONCILIATION OF GAAP TO NON-GAAPSELECT BUSINESS SEGMENT INFORMATION(In thousands)(Unaudited) Three Months Ended June 30, Nine Months Ended June 30, 2024 2023 2024 2023 DSA Revenue 44,219 46,758 135,548 134,874 Operating income 2,325 4,182 6,771 8,478 Operating income as a % of total revenue 2.2% 2.7% 1.9% 2.0%Add back: Depreciation and amortization 4,488 4,235 13,260 11,826 Restructuring costs 205 — 341 97 Startup costs 772 1,781 2,569 5,567 Total non-GAAP adjustments to operating income 5,465 6,016 16,170 17,490 Non-GAAP operating income 7,790 10,198 22,941 25,968 Non-GAAP operating income as a % of DSA revenue 17.6% 21.8% 16.9% 19.3%Non-GAAP operating income as a % of total revenue 7.4% 6.5% 6.4% 6.0% RMS Revenue 61,567 110,710 224,774 296,811 Operating income (loss) (7,447) 21,886 (32,973) (36,661)Operating income (loss) as a % of total revenue (7.0%) 13.9% (9.2%) (8.5%)Add back: Depreciation and amortization 9,401 9,629 28,781 28,291 Restructuring costs 252 1,303 2,518 3,212 Amortization of inventory step up 49 136 209 563 Other unusual, third party costs 2,270 2,012 4,628 3,152 Resolution and Plea Agreements 2,000 — 28,500 — Goodwill impairment loss — — — 66,367 Total non-GAAP adjustments to operating income (loss) 13,972 13,080 64,636 101,585 Non-GAAP operating income 6,525 34,966 31,663 64,924 Non-GAAP operating income as a % of RMS revenue 10.6% 31.6% 14.1% 21.9%Non-GAAP operating income as a % of total revenue 6.2% 22.2% 8.8% 15.0% Unallocated Corporate Operating Expenses (15,630) (17,285) (47,037) (55,737)Unallocated corporate operating expenses as a % of total revenue (14.8)% (11.0)% (13.1)% (12.9 Add back: Depreciation and amortization 230 — 483 — Stock option expense 1,337 2,029 5,118 5,856 Acquisition and integration costs — 105 70 1,193 Other unusual, third party costs — 572 — 572 Total non-GAAP adjustments to operating loss 1,567 2,706 5,671 7,621 Non-GAAP operating loss (14,063) (14,579) (41,366) (48,116)Non-GAAP operating loss as a % of total revenue (13.3)% (9.3)% (11.5)% (11.1)% Total Revenue 105,786 157,468 360,322 431,685 Operating loss (20,752) 8,783 (73,239) (83,920)Operating loss as a % of total revenue (19.6)% 5.6% (20.3)% (19.4%)Add back: Depreciation and amortization 14,119 13,864 42,524 40,117 Stock compensation expense 1,337 2,029 5,118 5,856 Restructuring costs 457 1,303 2,859 3,309 Acquisition and integration costs — 105 70 1,193 Amortization of inventory step up 49 136 209 563 Startup costs 772 1,781 2,569 5,567 Other unusual, third party costs 2,270 2,584 4,628 3,724 Resolution and Plea Agreements 2,000 — 28,500 — Goodwill impairment loss — — — 66,367 Total non-GAAP adjustments to operating loss 21,004 21,802 86,477 126,696 Non-GAAP operating income 252 30,585 13,238 42,776 Non-GAAP operating income as a % of total revenue 0.2% 19.4% 3.7% 9.9% INOTIV, INC.RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA(In thousands)(Unaudited) Three Months EndedJune 30, Nine Months Ended June 30, 2024 2023 2024 2023 GAAP Consolidated Net (Loss) Income (26,087) 365 (89,994) (96,196)Adjustments (a) Interest expense 12,116 10,786 34,568 31,751 Income tax benefit (6,863) (2,380) (16,721) (20,820)Depreciation and amortization 14,119 13,864 42,524 40,117 Stock compensation expense 1,337 2,029 5,118 5,856 Acquisition and integration costs (1) — 506 70 1,594 Startup costs 772 1,781 2,569 5,567 Restructuring costs (2) 457 1,303 2,859 3,309 Unrealized foreign exchange (gain) loss 33 (517) (576) (6)Amortization of inventory step up 49 136 209 563 (Gain) loss on disposition of assets (79) 68 (938) 319 Other unusual, third party costs 2,270 2,584 4,628 3,724 Resolution and Plea Agreements (4) 2,000 — 28,500 — Goodwill impairment loss (3) — — — 66,367 Adjusted EBITDA (b) $124 $30,525 $12,816 $42,145 GAAP consolidated net (loss) income as a percent of total revenue (24.7)% 0.2% (25.0)% (22.3)%Adjustments as a percent of total revenue 24.8% 19.2% 28.5% 32.0%Adjusted EBITDA as a percent of total revenue 0.1% 19.4% 3.6% 9.8% (a) Adjustments to certain GAAP reported measures for the three and nine months ended June 30, 2024 and 2023 include, but are not limited to, the following: (1) For the three and nine months ended June 30, 2024 and 2023, represents charges for legal services, accounting services, travel and other related activities in connection with various acquisitions and the related integration of those acquisitions.(2) For the three and nine months ended June 30, 2024, primarily represents costs incurred in connection with the exit of multiple sites and the enablement of the in-house integration of Inotiv’s North American transportation operations as previously disclosed. For the three and nine months ended June 30, 2023, primarily represents costs incurred in connection with the exit of multiple sites as previously disclosed.(3) For the nine months ended June 30, 2023, represents a non-cash goodwill impairment charge of $66.4 million related to the RMS segment. (4) For the three and nine months ended June 30, 2024, represents a charge related to the Resolution and Plea Agreements as it relates to the matter in which the U.S. Department of Justice, together with federal and state law enforcement agents, executed a search and seizure warrant on the Cumberland facility on May 18, 2022. (b) Adjusted EBITDA - Consolidated net loss before interest expense, income tax benefit, depreciation and amortization, stock compensation expense, acquisition and integration costs, startup costs, restructuring costs, unrealized foreign exchange (gain) loss, amortization of inventory step up (gain) loss on disposition of assets, other unusual, third party costs, the charge in connection with the Resolution and Plea Agreements and goodwill impairment loss.

Director Dr. Malte Peters named Chief Executive Officer and Director Terry Coelho named Executive Vice President and Chief Financial OfficerCompany is conducting a review of its business operations and strategy to determine best path to create shareholder value and realize the full potential of HB-200Sean Cassidy appointed to the Board of Directors NEW YORK and VIENNA, July 22, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK) (”HOOKIPA” or the “Company”), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced the appointment of Directors Dr. Malte Peters as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer, effective July 22, 2024. They will both retain their positions on the Board of Directors (“Board”). They succeed Jörn Aldag and Reinhard Kandera as CEO and CFO, respectively, who will be leaving the Company and stepping down from the Board. Dr. Peters and Ms. Coelho, in close collaboration with the Board, will lead a review of HOOKIPA’s business strategy and operations to determine the best path to realize the full potential of HB-200 and create shareholder value. The review process will not impact HOOKIPA’s operations or clinical trials. Dr. Jan van de Winkel, Chairman of the Board, said: “HOOKIPA has entered a critical new phase of its development for HB-200. The Company has received PRIME designation from the European Medicines Agency, reached alignment on a clinical development strategy with the U.S. Food and Drug Administration with a path to potential accelerated approval, and announced the pivotal Phase 2/3 trial design. The Company also continues to advance its other development programs, including those in collaboration with Gilead, with the first person recently dosed in the Phase 1b clinical trial of HB-500 for the treatment of HIV. “The Board of Directors determined that Dr. Peters and Ms. Coelho are the right leaders to help the Company execute through this next stage of development and realize the significant opportunity HB-200 represents, with the aim of ensuring that the Company’s attractive business prospects result in value for shareholders. Dr. Peters is a seasoned executive with deep experience in bringing new therapies to patients, while Ms. Coelho is a proven CFO with significant expertise in business strategy and development, finance, and M&A,” Dr. van de Winkel continued. The Company also announced that Sean Cassidy will join its Board of Directors, Audit Committee and Compensation Committee, effective July 22, 2024, succeeding Ms. Coelho as Chair of the Audit Committee. Mr. Cassidy most recently served as the Chief Financial Officer of Arvinas (NASDAQ: ARVN) through February 2024, where he led the company through numerous private and public financings as well as multiple business development transactions. “I want to thank Joern Aldag and Reinhard Kandera for their contributions to HOOKIPA and wish them all the best for the future. I am also pleased to welcome Mr. Cassidy to our Board. He brings extensive financial experience that will help HOOKIPA in its next phase of development,” Dr. van de Winkel concluded. About Dr. Malte Peters Dr. Malte Peters has over two decades of experience as an executive in the pharmaceutical and biotech industries. He is among the most knowledgeable translational research and clinical development leaders in the industry, with deep operational and medical experience in oncology and immunology. Dr. Peters joined HOOKIPA’s Board of Directors in January 2023 and served as the Company’s interim Senior Clinical Advisor following the departure of the Chief Medical Officer in 2023. While in the role, Dr. Peters oversaw the implementation of an experienced drug development leadership team, as well as the development of the pivotal HB-200-004 protocol endorsed by FDA. Dr. Peters most recently served as Chief Research and Development Officer at MorphoSys, where he oversaw the company’s research and development pipeline, including the design and execution of three pivotal studies leading to global regulatory approval of Monjuvi/Minjuvi. Prior to MorphoSys, Dr. Peters was Global Head of Clinical Development of the biopharmaceuticals business unit of Sandoz in Germany. Dr. Peters also spent 12 years in leadership positions at Novartis Oncology, including Vice President, Clinical Head and Site Head for Basel, East Hanover and Shanghai. While at Novartis, he was responsible for multiple development programs and clinical trials, contributing to the approval of 28 cancer therapies. Dr. Peters serves on the Board of Directors at Tango Therapeutics and is a Strategic Alliance Officer for the European Organisation for Research and Treatment of Cancer (EORTC). Dr. Peters is board certified in internal medicine. He earned his medical degree from Freie Universität in Berlin and was trained at the Universities of Padova, Italy and Bochum and Berlin, Germany. He received his habilitation in Internal Medicine from the University of Mainz, Germany. About Terry Coelho Terry Coelho has over 35 years of experience as a multinational leader and executive with broad business, strategic, and leadership experience across all areas of finance, business development, investor relations, commercial, and supply chain operations at companies in the pharmaceutical, consumer goods, and chemicals industries. Ms. Coelho joined HOOKIPA’s Board of Directors in April 2023, bringing with her a proven track record of successfully leading business transformations, strategic planning, financings, business and organizational development, and business integration. At HOOKIPA, she has served as Audit Committee Chair and as a member of the Compensation Committee. Ms. Coelho most recently served as CFO for Gamida Cell (NASDAQ: GMDA), where she led the Company’s M&A and business development efforts and was instrumental in securing a successful strategic restructuring agreement for the Company. Prior to that, Ms. Coelho held a variety of executive leadership roles, including Executive Vice President, Chief Financial Officer and Chief Business Development Officer for CinCor Pharma, Inc., where she successfully led the company through its 2022 IPO and large follow-on offering, as well as prepared the company for its eventual sale to Astra Zeneca. She also has served as Executive Vice President and Chief Financial Officer at BioDelivery Sciences International, and Chief Financial Officer at both Balchem Corporation and Diversey, Inc. Ms. Coelho’s experience includes over seven years at Novartis Pharmaceuticals, primarily with the Oncology division, where she held roles of increasing responsibility focused on business planning and leading the global oncology development finance organization, and 20 years of experience with Mars Incorporated in senior leadership roles, including starting up the Mars chocolate business in Brazil as CEO and General Manager. Ms. Coelho also serves on the Board of Directors, including as Audit Committee Chair, for both Entero Therapeutics and Inotiv, Inc. Ms. Coelho graduated summa cum laude from The American University in Washington, D.C. and earned her MBA from the Instituto Brasileiro de Mercado de Capitais (IBMEC) in Rio de Janeiro, Brazil. She is a founding member of the CFO Leadership Council (Charlotte and Raleigh chapters) About Sean Cassidy Sean Cassidy brings over 20 years of experience in the biotechnology, pharmaceutical and life sciences industries, most recently serving as the Chief Financial Officer of Arvinas (NASDAQ: ARVN) from July 2013 to February 2024. While at Arvinas, he led the company through numerous private and public financings, including its IPO in 2018, as well as multiple business development transactions with leading pharmaceutical companies including Merck, Genentech, Pfizer and Bayer. Previously, Mr. Cassidy was the Chief Financial officer at Axerion Therapeutics, Chief Financial Officer of CuraGen Corporation, and the Director and Controller of 454 Life Sciences Corporation. Mr. Cassidy sits on the board of directors of Automera Therapeutics, Abbratech and ReNetx Bio and is a board member of the Friends of Yale New Haven Children’s Hospital, a nonprofit organization that helps improve the health and well-being of pediatric patients and their families. Mr Cassidy is a Certified Public Accountant and holds a Bachelor of Science in accounting and finance and a master’s degree in business administration from the University of Connecticut. About HB-200HB-200 is HOOKIPA’s lead oncology candidate engineered with the company’s proprietary replicating arenaviral vector platform. It comprises two single-vector compounds with arenaviral backbones based on lymphocytic choriomeningitis virus (LCMV) and pichinde virus (PICV). Both express the same transgene encoding an E7E6 fusion protein derived from HPV16. HB-200 is an alternating 2-vector immunotherapy designed to further focus the immune response against the encoded antigen. HB-200 in combination with pembrolizumab received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of first-line HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma. These designations are supported by preliminary clinical evidence from the Phase 1/2, open-label, clinical trial (NCT04180215) evaluating safety, T cell response, and efficacy based on objective response rate (ORR) and disease control rate (DCR) as defined by RECIST 1.1. 1 Harrington et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal of Clinical Oncology. 2023;41(4);790-802. About HB-500HB-500 comprises two genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-500 vectors have been engineered to deliver HIV antigens derived from parts of key, immunogenic regions of HIV type 1 (HIV-1) proteins that are highly conserved within HIV-1 clade B variants. The designed immunogens differ from each other by their amino acid sequence allowing for coverage of >80% of circulating HIV-1 viral variants. About HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead. Find out more about HOOKIPA online at www.hookipapharma.com. Forward Looking StatementsCertain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “anticipates”, “believes,” “expects,” “plans,” “potential,” “target,” “will,” “would” or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA’s statements regarding the potential of its product candidates to positively impact quality of life and alter the course of disease in the patients it seeks to treat, HOOKIPA’s plans, strategies, expectations and anticipated milestones for its preclinical and clinical programs, and the probability of successfully developing and receiving regulatory approval for its product candidates, including accelerated approval for HB-200. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof, the timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs, the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for HB-200, HB-700, HB-400 and HB-500, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property, HOOKIPA’s ability to achieve the expected benefits of its strategic reprioritization and other matters that could affect the sufficiency of existing cash to fund operations. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see HOOKIPA’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA’s subsequent filings with the Securities and Exchange Commission, which are available on the SEC’s website at https://sec.gov and HOOKIPA’s website at www.hookipapharma.com. Except as specifically noted otherwise, all information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law. Availability of Other Information About HOOKIPAInvestors and others should note that we announce material financial information to our investors using our investor relations website, https://ir.hookipapharma.com/, SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our investors and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the social media channels listed on our investor relations website. For further information, please contact: Investors Michael Kaiser michael.kaiser@hookipapharma.com +1 (917) 984-7537 MediaTom Davies / Emma Youngtom.davies@kekstcnc.com / emma.young@kekstcnc.com

WEST LAFAYETTE, Ind., June 10, 2024 (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 provided the following business updates: Hillcrest, U.K. expansion project completedExtension of the maturity date of the $3.7 million OBRC payable note to July 2025 Robert Leasure Jr., President and Chief Executive Officer, commented, “We have substantially completed the Hillcrest, U.K. expansion and improvements, which allows for two new customers with long term contracts, to begin occupying their new space at this facility and for the transfer of our Blackthorn, U.K. operations into Hillcrest. The Hillcrest project has been another significant part of our transformation plan which we initiated in 2022. The transformation has included multiple site closures, significant investments in remaining facilities to support growth, and included investments in infrastructure, animal welfare and safety improvements. “We are also pleased OBRC agreed to further extend the maturity date of the OBRC payable note. Inotiv will continue to evaluate opportunities to optimize our balance sheet. “We remain focused on near-term growth initiatives, which include the ramp up of sales and marketing efforts, and the development and growth of new services. Further, we are delighted to be reaching the conclusion of major site consolidation and integration projects, with their expected efficiency gains, plus we continue to invest in animal welfare and safety initiatives. We look forward to realizing the long-term benefits of our investments as part of our efforts to transform the company into a leading global mid-sized CRO.” Hillcrest, U.K. Facilities Expansion Inotiv’s Hillcrest, U.K, expansion project is now substantially complete, and the Company is working diligently with new customers to finalize their occupancy in the expanded and upgraded facility by the end of June 2024. With the Hillcrest investments being completed, the Company will also initiate the transition of the operations of the Blackthorn, U.K. facility, to the expanded Hillcrest facility, expected to be complete by September 2024. Extension of OBRC Payable Note Inotiv acquired Orient BioResource Center’s ("OBRC") primate quarantine and holding facility, located near Alice, Texas, in 2022. As part of the original purchase consideration, the Company agreed to leave in place a payable note owed by OBRC to the seller in the amount of $3.7 million. Originally, the payable note bore no interest and was required to be paid to the seller 18 months after the closing. The maturity date of the payable note of $3.7 million has now been extended to July 27, 2025, and will accrue interest beginning July 27, 2024 at a rate of 4.6% per annum. About the Company Inotiv, Inc. is a leading contract research organization dedicated to providing nonclinical and analytical drug discovery and development services and research models and related products and services. The Company’s products and services focus on bringing new drugs and medical devices through the discovery and preclinical phases of development, all while increasing efficiency, improving data, and reducing the cost of taking new drugs to market. Inotiv is committed to supporting discovery and development objectives as well as helping researchers realize the full potential of their critical R&D projects, all while working together to build a healthier and safer world. Further information about Inotiv can be found here: https://www.inotivco.com/. This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact included in this release, are forward-looking statements, including, but not limited to, statements about the Company’s plans for its Hillcrest and Blackthorn, U.K. facilities and operations, and the Company’s growth initiatives. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “outlook,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. All forward-looking statements are subject to significant risks, uncertainties and changes in circumstances that could cause actual results and outcomes to differ materially from the forward-looking statements. These forward-looking statements are not guarantees of future performance and involve risks, assumptions and uncertainties, including, without limitation, the Company’s inability to execute its plans for its Hillcrest and Blackthorn, U.K. facilities and operations and realize the expected benefits from these actions; the Company’s inability to execute on or achieve its growth initiatives; and those that are described in the Company’s most recent Annual Report on Form 10-K, in the Company’s Quarterly Reports on Form 10-Q, and in other documents that the Company files or furnishes with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual outcomes may vary materially from those indicated or anticipated by such forward-looking statements. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Except to the extent required by law, the Company does not undertake, and expressly disclaims, any duty or obligation to update publicly any forward-looking statement after the date of this announcement, whether as a result of new information, future events, changes in assumptions or otherwise. Company ContactInvestor RelationsInotiv, Inc.LifeSci AdvisorsBeth A. Taylor, Chief Financial OfficerBob Yedid(765) 497-8381(516) 428-8577btaylor@inotivco.combob@lifesciadvisors.com