tiprankstipranks
Trending News
More News >
Inotiv (NOTV)
NASDAQ:NOTV
US Market

Inotiv (NOTV) Risk Analysis

Compare
417 Followers
Public companies are required to disclose risks that can affect the business and impact the stock. These disclosures are known as “Risk Factors”. Companies disclose these risks in their yearly (Form 10-K), quarterly earnings (Form 10-Q), or “foreign private issuer” reports (Form 20-F). Risk factors show the challenges a company faces. Investors can consider the worst-case scenarios before making an investment. TipRanks’ Risk Analysis categorizes risks based on proprietary classification algorithms and machine learning.

Inotiv disclosed 42 risk factors in its most recent earnings report. Inotiv reported the most risks in the “Finance & Corporate” category.

Risk Overview Q4, 2025

Risk Distribution
42Risks
29% Finance & Corporate
26% Legal & Regulatory
14% Ability to Sell
14% Macro & Political
10% Tech & Innovation
7% Production
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
This chart displays the stock's most recent risk distribution according to category. TipRanks has identified 6 major categories: Finance & corporate, legal & regulatory, macro & political, production, tech & innovation, and ability to sell.

Risk Change Over Time

2022
Q4
S&P500 Average
Sector Average
Risks removed
Risks added
Risks changed
Inotiv Risk Factors
New Risk (0)
Risk Changed (0)
Risk Removed (0)
No changes from previous report
The chart shows the number of risks a company has disclosed. You can compare this to the sector average or S&P 500 average.

The quarters shown in the chart are according to the calendar year (January to December). Businesses set their own financial calendar, known as a fiscal year. For example, Walmart ends their financial year at the end of January to accommodate the holiday season.

Risk Highlights Q4, 2025

Main Risk Category
Finance & Corporate
With 12 Risks
Finance & Corporate
With 12 Risks
Number of Disclosed Risks
42
No changes from last report
S&P 500 Average: 31
42
No changes from last report
S&P 500 Average: 31
Recent Changes
0Risks added
0Risks removed
1Risks changed
Since Dec 2025
0Risks added
0Risks removed
1Risks changed
Since Dec 2025
Number of Risk Changed
1
-7
From last report
S&P 500 Average: 3
1
-7
From last report
S&P 500 Average: 3
See the risk highlights of Inotiv in the last period.

Risk Word Cloud

The most common phrases about risk factors from the most recent report. Larger texts indicate more widely used phrases.

Risk Factors Full Breakdown - Total Risks 42

Finance & Corporate
Total Risks: 12/42 (29%)Above Sector Average
Share Price & Shareholder Rights4 | 9.5%
Share Price & Shareholder Rights - Risk 1
Changed
If we are unable to maintain listing of our securities on The Nasdaq Capital Market, it may be more difficult for our shareholders to sell their securities and may adversely affect the market liquidity of our common shares and our ability to obtain financing to fund our operations.
Our common shares are listed on The Nasdaq Stock Market LLC ("Nasdaq"). Nasdaq requires listed issuers to comply with certain standards in order to remain listed on its exchange. If, for any reason, Nasdaq should delist our securities from trading on its exchange and we are unable to obtain listing on another reputable national securities exchange, a reduction in some or all of the following may occur, each of which could materially adversely affect us and our shareholders: - the liquidity of our common shares;- the market price of our common shares;- our ability to obtain financing for the continuation of our operations;- the number of institutional and general investors that will consider investing in our common shares;- the number of market makers in our common shares;- the availability of information concerning the trading prices and volume of our common shares; and - the number of broker-dealers willing to execute trades in our common shares. In order to maintain our listing on Nasdaq, we must satisfy minimum financial and other requirements including, without limitation, a requirement that our closing bid price be at least $1.00 per share. On December 31, 2025, we received written notice from Nasdaq stating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Rule") because our common shares failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. This letter provides an initial 180 calendar day period, or until June 29, 2026, in which to regain compliance. If we do not regain compliance by July 29, 2026, we may be eligible for an additional 180-day grace period. We intend to continue to monitor the bid price for our common shares and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Rule, including the potential of seeking shareholder approval of a reverse split of our common shares in order to increase the trading price of our common shares in compliance with the Minimum Bid Price Rule. There is no assurance, however, that we will be eligible for an additional compliance period or that any actions we take will resolve the deficiency. If we fail to regain and maintain compliance with the Minimum Bid Price Rule or we fail to continue to meet all other applicable continued listing requirements for Nasdaq, our common shares may be delisted, which may adversely affect the market liquidity of our common shares and our ability to obtain financing to fund our operations. The perception among investors that we are at a heightened risk of delisting could negatively affect the market price and trading volume of our common shares. If our common shares are delisted from Nasdaq, the delisting could: substantially decrease trading in our common shares; adversely affect the market liquidity of our common shares as a result of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws; adversely affect our ability to issue additional securities or obtain additional financing in the future on acceptable terms, if at all; result in the potential loss of confidence by investors, customers, partners and employees and fewer business development opportunities; and result in limited news and analyst coverage. Additionally, the market price of our common shares may decline further, and shareholders may lose some or all of their investment.
Share Price & Shareholder Rights - Risk 2
Anti-takeover provisions in our organizational documents and under Indiana law may discourage or prevent a change in control, even if a sale of us would benefit our shareholders, which could cause our stock price to decline and prevent attempts by shareholders to replace or remove our current management.
Our Second Amended and Restated Articles of Incorporation and Fourth Amended and Restated Bylaws contain provisions that may delay or prevent a change in control, discourage bids at a premium over the market price of our common shares, harm the market price of our common shares, and diminish the voting and other rights of the holders of our common shares. These provisions include: - dividing our board of directors into three classes serving staggered three-year terms;- authorizing our board of directors to issue preferred stock and additional common shares without shareholder approval;- requiring one or more written demands signed and dated by holders of at least 25% of all the votes entitled to be cast on any issue proposed to be considered at a special meeting for shareholders to call a special meeting;- prohibiting our shareholders from amending our Bylaws; and - requiring advance notice for nominating directors at shareholders' meetings. Our board of directors also has the ability to adopt a shareholder rights agreement, sometimes called a "poison pill," providing for the issuance of a new series of preferred stock to holders of common shares. In the event of a takeover attempt, this preferred stock would give rights to holders of common shares (other than the potential acquirer) to buy additional common shares at a discount, leading to the dilution of the potential acquirer's stake. The board's ability to adopt a poison pill may discourage potential takeover offers, particularly by suitors the board may view as unfavorable transaction partners. As an Indiana corporation, we are governed by the Indiana Business Corporation Law (as amended from time to time, the "IBCL"). Under specified circumstances, certain provisions of the IBCL related to control share acquisitions, business combinations, and constituent interests may delay, prevent, or make more difficult unsolicited acquisitions or changes of control. These provisions may also have the effect of preventing changes in our management. It is possible that these provisions could make it more difficult to accomplish Company transactions that shareholders might deem to be in their best interest.
Share Price & Shareholder Rights - Risk 3
The resale of certain common shares underlying warrants issued with the Second Lien Notes and covered by a resale registration statement could adversely affect the market price of our common shares, which result could in turn negatively affect our ability to raise additional equity capital.
Pursuant to a Registration Rights Agreement which we entered with the purchasers of, and the structuring agent for, our Second Lien Notes and warrants, we filed a registration statement registering the resale of 4,146,250 of our common shares held by the shareholders who are parties to the Registration Rights Agreement. The resale registration statement permits the resale of these shares at any time after the exercise of the warrants and without restriction. The sale, or availability for sale, of our common shares in the public market may adversely affect the prevailing market price of our common shares and may impair our ability to raise additional equity capital. The resale of a substantial number of our common shares in the public market could adversely affect the market price for our common shares and make it more difficult for you to sell our common shares at times and prices that you feel are appropriate. Furthermore, because there are a large number of shares registered pursuant to the resale registration statement, the selling shareholders named in such registration statement may continue to offer shares covered by the resale registration statement for a significant period of time, the precise duration of which cannot be predicted. Accordingly, the adverse market and price pressures resulting from an offering pursuant to the resale registration statement may continue for an extended period of time and continued negative pressure on the market price of our common shares could have a material adverse effect on our ability to raise additional equity capital.
Share Price & Shareholder Rights - Risk 4
Our share price could continue to be volatile and our trading volume may fluctuate substantially.
The market price of our common shares has historically been and might continue to be volatile. Many factors may have a significant impact on the future price of our common shares, including: - the fact that there is substantial doubt about our ability to continue as a going concern;- our failure to successfully implement our business objectives;- our businesses, operations, results and prospects;- changes in revenue or earnings estimates, or changes in recommendations by equity research analysts;- compliance with ongoing regulatory requirements;- market acceptance of our products;- technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors;- changes in government regulations, taxes, legal proceedings and other developments;- inspections, investigations and enforcement actions by regulatory authorities against us or our principal suppliers;- negative information related to, or adverse regulatory or other actions against us or our principal suppliers;- general economic conditions, including changes in interest rates, and other external factors;- actual or anticipated fluctuations in our quarterly financial and operating results and those of our competitors;- announcements concerning us or our competitors;- market conditions in contract research services or research model industries;- additions or departures of key management personnel;- future mergers and strategic alliances;- investor sentiment toward the stock of animal breeding companies;- maintenance of acceptable credit ratings or credit quality;- ability to fund future growth;- the degree of trading liquidity in our common shares; and - our ability to meet the minimum standards required for remaining listed on The Nasdaq Capital Market. Factors which may impact the price of our common shares include influences beyond our control, such as market conditions and changes in the pharmaceutical and biotechnology industries we serve. The stock market, and in particular the market for pharmaceutical and biotechnology company stocks, has experienced periods of significant price and volume fluctuations, including as a result of recent elevated interest rates and inflation. Volatility and valuation decline have affected the market prices of securities issued by many companies, often for reasons unrelated to their operating performance, and also have adversely affected the price of our common shares. Following periods of volatility in the overall market and in the market price of a company's securities, securities class action litigation and derivative securities litigation have often been instituted against that company, as has been the case with us. Such occurrences of litigation could result in very substantial costs, divert management's attention and resources and harm our business, operating results and financial condition.
Accounting & Financial Operations1 | 2.4%
Accounting & Financial Operations - Risk 1
Our management concluded that our disclosure controls and procedures and our internal control over financial reporting were not effective as of September 30, 2025 and as of prior dates due to material weaknesses in internal control over financial reporting. If we are unable to remediate these material weaknesses and maintain an effective system of disclosure controls and procedures and internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner, which may adversely affect investor confidence in us and materially and adversely affect our business and financial results.
Our management concluded that our disclosure controls and procedures and our internal control over financial reporting were not effective as of September 30, 2025, 2024 and 2023 due to material weaknesses in internal controls, as described further in Part III, Item 9A – Controls and Procedures. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis. Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud. Although we have taken and continue to take, steps to remediate the material weaknesses, as of September 30, 2025, they have not been remediated and there is no assurance that any remediation efforts will ultimately have the intended effects. If we identify any new material weaknesses in the future, any such newly identified material weakness could limit our ability to prevent or detect a misstatement of our accounts or disclosures that could result in a material misstatement of our annual or interim financial statements. In such case, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting and our stock price may decline as a result. We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to avoid potential future material weaknesses.
Debt & Financing4 | 9.5%
Debt & Financing - Risk 1
We may need additional capital, and any additional capital we seek may not be available in the amount or at the time we need it.
Successful execution of our growth plans will require that we have access to capital. Our expected financing needs are based upon management's estimates as to future revenue and expense. Our business plan and financing needs are subject to change based upon, among other factors, our ability to increase revenues and manage expenses and the timing and extent of our future capital expenditures and acquisition activity. If our estimates of our financing needs change, we may need additional capital more quickly than we expect or we may need a greater amount of capital. In general, additional capital may be raised through the sale of common shares, including through our at-the-market offering program with Jefferies LLC, preferred equity or convertible debt securities, entry into debt facilities or other third-party funding arrangements. The sale of equity, convertible debt securities and warrants may result in dilution to our shareholders and those securities may have rights senior to those of our common shares. Agreements entered into in connection with such capital raising activities could contain covenants that would restrict our operations or require us to relinquish certain rights. Additional capital may not be available on reasonable terms, or at all. If we cannot timely raise any needed funds, we may be forced to reduce our operating expenses, which could adversely affect our ability to implement our long-term strategic roadmap and grow our business. The financial covenants under the Company's Credit Agreement include, among others, a requirement to not permit the consolidated debt to consolidated EBITDA of the Company to exceed certain leverage thresholds under the Credit Agreement. For the fiscal year ended September 30, 2025, the Company had negative operating cash flows, operating losses and net losses. As of September 30, 2025, the Company has cash and cash equivalents of $21,741 and access to a $15,000 revolver, which had a $3,000 balance outstanding as of September 30, 2025. If the Company's results of operations in the twelve months following the date of this report do not improve relative to fiscal 2025 results, the Company will be at risk of non-compliance with its financial covenants under its Credit Agreement. Further, the Company's Term Loan Facility, DDTL and Incremental Term Loans mature in the next 12 months. Management's fiscal 2026 annual operating plan forecasts noncompliance with its financial covenants under the Credit Agreement. If at any time in the twelve months following the date of this report, the Company fails to comply with its financial covenants which remains unremedied for the period of time stipulated under the Credit Agreement, this would constitute an event of default under the Credit Agreement and the lenders may, among other remedies set out under the Credit Agreement, declare all or any portion of the outstanding principal amount of the borrowings (which include the term loans) plus accrued and unpaid interest to be immediately due and payable. Furthermore, if the lenders were to accelerate the loans under the Credit Agreement, such acceleration would constitute a default under our indentures governing the Notes and the Second Lien Notes which, if not cured within 30 days following notice of such default from such trustees or holders of 25 percent of the Notes and from the trustee or holders of 30 percent of the Second Lien Notes, would permit the trustee or such holders to accelerate the Notes and the Second Lien Notes. If the loans under the Credit Agreement, the Notes and the Second Lien Notes are accelerated, the Company does not believe its existing cash and cash equivalents, together with cash generated from operations, would be sufficient to fund its operations, satisfy its obligations, including cash outflows for planned targeted capital expenditures, and repay the entirety of its outstanding senior term loans, outstanding Notes, outstanding revolving credit facility balance and outstanding Second Lien Notes in the next twelve months. Additionally, access to the revolver would be restricted and such funds would not be available to pay for any operating activities. Our evaluation of the Company's ability to continue as a going concern in accordance with U.S. generally accepted accounting principles entailed analyzing prospective fully implemented operating budgets and forecasts for expectations of our cash needs and comparing those needs to the current cash and cash equivalent balances in order to satisfy our obligations, including cash outflows for planned targeted capital expenditures, and to comply with minimum liquidity and financial covenant requirements under our debt covenants related to borrowings pursuant to its Credit Agreement for at least the next twelve months. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented and are outside of its control as of the date the consolidated financial statements are issued. When substantial doubt exists under this methodology, we evaluate whether the mitigating effect of our plans sufficiently alleviates substantial doubt about our ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the consolidated financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. As a result of the factors outlined above, substantial doubt about our ability to continue as a going concern exists. In addition, the fact that there is substantial doubt about the Company's ability to continue as a going concern and that the Company is operating under these conditions may adversely affect the Company's stock price, its ability to raise capital, its ability to comply with its Credit Agreement and its normal business operations, among other implications.
Debt & Financing - Risk 2
Our failure to comply with the terms of our Credit Agreement could result in an event of default that could materially adversely affect our business, financial condition and results of operations.
If there were an event of default under our Credit Agreement, all amounts outstanding under that agreement, including the senior term loans and revolving credit facility, as well as the Notes and the Second Lien Notes could be due and payable immediately, which would have an adverse impact on our business, financial condition and results of operations. An event of default may occur should our assets or cash flow be insufficient to fully repay borrowings under our Credit Agreement, whether paid in the ordinary course or accelerated, or if we are unable to maintain compliance with relevant obligations thereunder, including financial and other covenants. Various risks and uncertainties may impact our ability to comply with our obligations under the Credit Agreement. Management's fiscal 2026 annual operating plan forecasts noncompliance with its financial covenants under the Credit Agreement. Our inability to comply with any of the provisions of the Credit Agreement could result in a default under it. If at any time in the twelve months following the date of this report the Company fails to comply with its financial covenants which remains unremedied for the period of time stipulated under the Credit Agreement, this would constitute an event of default under the Credit Agreement and the lenders may, among other remedies set out under the Credit Agreement, declare all or any portion of the outstanding principal amount of the borrowings (which include the term loans) plus accrued and unpaid interest to be immediately due and payable. Furthermore, if the lenders were to accelerate the loans under the Credit Agreement, such acceleration would constitute a default under our indentures governing the Notes and the Company's Second Lien Notes which, if not cured within 30 days following notice of such default from such trustees or holders of 25 percent of the Notes and from the trustee or holders of 30 percent of the Second Lien Notes, would permit the trustee or such holders to accelerate the Notes and the Second Lien Notes. If the loans under the Credit Agreement, the Notes and the Second Lien Notes are accelerated, the Company does not believe its existing cash and cash equivalents, together with cash generated from operations, would be sufficient to fund its operations, satisfy its obligations, including cash outflows for planned targeted capital expenditures, and repay the entirety of its outstanding senior term loans, outstanding Notes, outstanding revolving credit facility balance and outstanding Second Lien Notes in the next twelve months. In addition, if we are unable to repay outstanding borrowings when due, the lenders also have the right to proceed against the collateral. The occurrence of any of these events could have a material adverse effect on our business, financial condition, results of operations and liquidity.
Debt & Financing - Risk 3
Our Credit Agreement contains covenants that restrict our business and financing activities. Our assets secure our obligations under the Credit Agreement and the Second Lien Notes and may be subject to foreclosure.
Our Credit Agreement contains various covenants, restrictions, and events of default. Among other things, these provisions require us to maintain certain financial ratios and impose certain limits on our ability to engage in certain activities. The restrictions in the Credit Agreement impose operating and financial restrictions on us and may limit our ability to compete effectively, take advantage of new business opportunities, or take other actions that may be in our, or our shareholders', best interests. Further, various risks and uncertainties may impact our ability to comply with our obligations under the Credit Agreement. Our obligations under the Credit Agreement and the Second Lien Notes are secured by all assets (other than certain excluded assets) of the Company and each of the subsidiary guarantors. Management's fiscal 2026 annual operating plan forecasts noncompliance with its financial covenants under the Credit Agreement. Our inability to comply with any of the provisions of the Credit Agreement could result in a default under it. If at any time in the twelve months following the date of this report the Company fails to comply with its financial covenants which remains unremedied for the period of time stipulated under the Credit Agreement, this would constitute an event of default under the Credit Agreement and the lenders may, among other remedies set out under the Credit Agreement, declare all or any portion of the outstanding principal amount of the borrowings (which include the term loans) plus accrued and unpaid interest to be immediately due and payable. Furthermore, if the lenders were to accelerate the loans under the Credit Agreement, such acceleration would constitute a default under our indentures governing the Notes and the Company's Second Lien Notes which, if not cured within 30 days following notice of such default from such trustees or holders of 25 percent of the Notes and from the trustee or holders of 30 percent of the Second Lien Notes, would permit the trustee or such holders to accelerate the Notes and the Second Lien Notes. If the loans under the Credit Agreement, the Notes and the Second Lien Notes are accelerated, the Company does not believe its existing cash and cash equivalents, together with cash generated from operations, would be sufficient to fund its operations, satisfy its obligations, including cash outflows for planned targeted capital expenditures, and repay the entirety of its outstanding senior term loans, outstanding Notes, outstanding revolving credit facility balance and outstanding Second Lien Notes in the next twelve months. In addition, if we are unable to repay outstanding borrowings when due, the lenders also have the right to proceed against the collateral. The occurrence of any of these events could have a material adverse effect on our business, financial condition, results of operations and liquidity.
Debt & Financing - Risk 4
We have significant indebtedness, which may impair our ability to raise capital or impact our ability to service our debt.
We have significant indebtedness, which may impair our ability to raise capital, including to expand our business, pursue strategic investments, and take advantage of financing or other opportunities that we believe to be in the best interests of the Company and our shareholders. Our senior term loans, of which the outstanding balance as of September 30, 2025 was $268,654, will mature on November 5, 2026. The Company does not believe its existing cash and cash equivalents, together with cash generated from operations, would be sufficient to fund its operations, satisfy its obligations, including cash outflows for planned targeted capital expenditures, and repay the entirety of its outstanding senior term loans, outstanding Notes, outstanding revolving credit facility balance and outstanding Second Lien Notes in the next twelve months. Further, the Credit Agreement will terminate on the maturity date, with any outstanding amounts under the revolving credit facility becoming due on that date and no further borrowings will be able to be made under the Credit Agreement. Our ability to make scheduled payments of the principal (including at maturity), to pay interest on or to refinance our indebtedness depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service our debt and make necessary capital expenditures. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, curtailing spend, restructuring debt, or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinance our indebtedness depends on numerous factors, including the debt market, the capital markets and our financial condition at such time. Our level of indebtedness may also impact our ability to service our debt, repay our debt at maturity and to comply with financial covenants and the other terms of our relevant credit arrangements, in which case our lenders might pursue available remedies up to and including terminating our credit arrangements and foreclosing on available collateral. While we have implemented efforts to curtail spending, there is no assurance that any such efforts will be successful or will have intended effect on our available cash.
Corporate Activity and Growth3 | 7.1%
Corporate Activity and Growth - Risk 1
We may fail to realize anticipated strategic and financial benefits from acquisitions, related integrations and our site optimization strategy.
We may not realize all of the anticipated benefits of our business acquisitions. These acquisitions may not further our business strategy as we expect, we may fail to successfully integrate the acquired operations as planned or to realize the synergies and other benefits we expected from the acquisitions, we have in the past, and may again in the future, experience unexpected adverse impacts on the acquired businesses, or we may otherwise not realize the expected return on our investments, any of which could adversely affect our business or operating results and potentially cause impairment to assets that we record as a part of the acquisitions, including intangible assets and goodwill. We may have difficulties managing the acquired businesses or retaining key personnel of the acquired companies. In addition, during recent periods, we have undertaken, and we plan to undertake additional, restructuring and site optimization initiatives, designed to allow us to reduce overhead and create efficiencies through scale. These initiatives present significant risks that may impair our ability to achieve anticipated operating enhancements and/or cost reductions, or otherwise harm our business, including higher than anticipated costs in implementing these initiatives, asset impairments and management distraction. If we fail to achieve some or all of the expected benefits of these initiatives, it could have a material adverse effect on our competitive position, business, financial condition, results of operations and cash flows.
Corporate Activity and Growth - Risk 2
We have and may further expand our business through acquisitions, which exposes us to various risks. Our due diligence of our past or future acquisitions may not have identified all pertinent risks, or the full magnitude of such risks, which could materially affect our business, financial condition, liquidity and results of operations.
We have completed several acquisitions and from time to time may review other acquisition candidates. Acquisitions involve numerous risks, including: - The inability of the Company to obtain financing for the acquisition of targets;- Difficulties and expenses in connection with integrating acquired companies and achieving expected benefits, including as related to the integration of departments, accounting and other systems, technologies, books and records and procedures;- Diversion of management's attention from daily operations to various integration activities;- The potential for disruption of prior operations and plans;- The risk that acquisitions could be dilutive to earnings, or in the event of acquisitions made through the issuance of our common shares to the shareholders of the acquired company, dilutive to the percentage ownership of our existing shareholders;- The adverse impact of risks facing the acquired companies, including losses resulting from undiscovered liabilities of acquired companies not covered by the indemnification we may obtain from the sellers;- Risks associated with the assimilation and retention of employees, including key employees;- The potential loss of, or adverse effects on, existing business relationships the acquired business has with suppliers and clients;- The potential need to address relevant internal control over financial reporting and disclosure control and procedures matters;- Possible deficiencies in operational processes and procedures;- Risks associated with carrying a relatively significant level of debt; and - The ability of our management team to manage expanded operations to meet operational and financial expectations. Our operating results or financial condition also may be adversely impacted by (i) claims or liabilities related to the acquired companies' businesses including, among others, claims from U.S. regulatory or other governmental agencies, such as those related to OBRC and Envigo, terminated employees, current or former clients or business partners, or other third parties; (ii) pre-existing contractual relationships of the acquired companies that we would not have otherwise entered into, the termination or modification of which may be costly or disruptive to our business; (iii) unfavorable accounting treatment as a result of the acquired companies' practices; and (iv) intellectual property claims or disputes. Certain of the companies we have acquired were not required to maintain an internal control infrastructure that would meet the standards of a public company, including the requirements of the Sarbanes-Oxley Act of 2002, and we may acquire similar companies in the future. The costs to implement such controls and procedures may be substantial and we could encounter unexpected delays and challenges in this implementation. In addition, we may discover significant deficiencies or material weaknesses in the quality of an acquired company's financial and disclosure controls and procedures which could result in additional costs or adversely affect our business or operating results, and, as has occurred with us, the accounting for acquisitions can be complex and may lead to material weaknesses. As part of our merger and acquisition due diligence, we utilize information provided by relevant sellers. As is true with any merger and acquisition transaction, we may not be aware of all liabilities, or the full magnitude of liabilities, of the acquired business at the time of acquisition. Potential incremental liabilities and additional risks and uncertainties related to our recent or future acquisitions not known or fully appreciated by us could negatively and materially impact our future business, financial condition and results of operations. For example, we have been the subject of a number of investigations, lawsuits, claims and other matters described in Note 15 - Contingencies and Commitments included in Part II, Item 8, that relate to the businesses and operations we acquired through the acquisitions of Envigo, OBRC and others.
Corporate Activity and Growth - Risk 3
Failure to manage growth effectively could cause our business to suffer and have an adverse effect on our business, operating results and financial condition.
To manage growth effectively, we must continually evaluate and evolve our organization. We must also manage our employees, operations, finances, technology and development and capital investments effectively. Our efficiency, productivity and the quality of our products and services may be adversely impacted if we do not integrate and manage growth effectively, or if we fail to appropriately coordinate across our organization. Our growth may place a strain on our resources, infrastructure and ability to maintain the quality of our products and services. You should not consider our past growth as indicative of future performance. Failure to manage our growth effectively could cause our business to suffer and have an adverse effect on our operating results and financial condition.
Legal & Regulatory
Total Risks: 11/42 (26%)Above Sector Average
Regulation3 | 7.1%
Regulation - Risk 1
Changes in government regulation or practices relating to the pharmaceutical, biotechnology and medical device industries could reduce demand for our services and products.
Governmental agencies throughout the world, but particularly in the United States, strictly regulate the drug development process. Our business depends on helping clients navigate complex drug development regulations. While new or stricter regulations can increase demand for our services, changes such as relaxed regulatory requirements, expedited drug approvals, or rules that make our services less competitive could reduce the demand for our products and services. For example, the FDA Modernization Act 2.0, passed in December 2022, removed certain references to animal testing in the FDCA to facilitate the broader acceptance of alternatives to animal testing. In April 2025, the FDA published a roadmap to reduce animal testing in preclinical safety studies with scientifically validated new approach methodologies. It is unpredictable whether and when any changes related to animal testing alternatives will occur, and a shift away from animal research could negatively impact our business, operations, or financial condition if we are unable to implement acceptable alternatives, or if they do not deliver comparable financial results, even if implemented.
Regulation - Risk 2
Any failure by us or our partners to comply with existing regulations or requirements could harm our reputation and operating results, and we could face substantial penalties and sanctions. Requirements to comply with new laws, regulations and guidance may have an adverse effect on our financial condition and results of operations.
Our operations in the United States are subject to various U.S. federal and state laws and regulations that govern, among other things, the manner in which we provide our products and services. Any failure on our part, or the part of partners, to comply with existing regulations or requirements could result in the termination of ongoing research or the disqualification of data for submission to regulatory authorities. For example, if we were to fail to properly monitor compliance with study protocols, the data collected could be disqualified. Under such circumstances, we may be contractually required to repeat a study at no further cost to the client, but at substantial cost to us. That development would harm our reputation, our prospects for future work and our operating results. The issuance of a notice from the FDA or the USDA, or other relevant authorities, based on a finding of a material violation by us of good clinical practice, good laboratory practice or good manufacturing practice requirements, animal welfare laws and regulations, or other applicable regulations or requirements could materially and adversely affect our business and financial performance, including fines or sanctions, debarment and/or permit and/or license suspension or revocation. Furthermore, the cost to comply with new federal or state legislation or regulations may adversely affect our operating results. Efforts to ensure that our business will comply with applicable laws, including healthcare laws and regulations, may involve substantial costs. In addition, the healthcare and other laws applicable to our business may change or be amended, and it is possible that governmental and enforcement authorities will conclude that our business practices do not comply with current or then-existing legal requirements. We may not properly interpret certain requirements or fail to timely report activities, when required. If any such actions are instituted against us, and we are not successful in defending ourselves, those actions could have a material impact on our business. For further information on these and other actions, see Note 15 - Contingencies and Commitments to the consolidated financial statements contained in Part II, Item 8.
Regulation - Risk 3
We are subject to inspections, investigations and enforcement actions by regulatory authorities, which could lead to penalties, including substantial fines, warning letters, a temporary restraining order or injunction, civil and/or criminal penalties, and/or license suspension or revocation.
We are subject to periodic inspections by regulatory authorities, including the FDA, the USDA and the U.S. Fish and Wildlife Service. As part of these inspections, the regulatory authorities seek to determine whether our facilities, operations and animal research model importation practices comply with applicable laws and regulations. Adverse findings as a result of these inspections have led, and in the future could lead, to enforcement actions, including substantial fines, warning letters that require corrective action (including facilities improvement requirements), revocation of approvals, exclusion from future participation in government healthcare programs, criminal prosecution and even the denial of the right to conduct business. For further information, see Note 15 - Contingencies and Commitments to the consolidated financial statements contained in Part II, Item 8. Inspections, investigations and/or other actions could result in penalties that could include a temporary restraining order or injunction, civil and/or criminal penalties, debarment and/or permit and/or license suspension or revocation. The imposition of any of these penalties or other restrictions on our business could adversely affect our business reputation and could have a material adverse impact on our financial condition, results of operations and stock price.
Litigation & Legal Liabilities2 | 4.8%
Litigation & Legal Liabilities - Risk 1
We are involved in legal proceedings that could adversely affect our business, financial condition, and results of operations.
We are involved in legal proceedings related to various matters, including employment, privacy and securities litigation, including purported class actions, and may become involved in other legal proceedings that arise from time to time in the future. For further information, see Note 15 - Contingencies and Commitments to the consolidated financial statements contained in Part II, Item 8. Any claims against us, whether meritorious or not, can be time-consuming, result in costly litigation, be harmful to our reputation, require significant management attention, divert significant resources, and require the payment of significant amounts through judgments or settlements. In addition, the expense of litigation and the timing of this expense from period to period are difficult to estimate and subject to change. Litigation and other claims are subject to inherent uncertainties and management's view of these matters may change in the future. Given the uncertain nature of legal proceedings generally, we are not able in all cases to estimate the amount or range of loss that could result from an unfavorable outcome. We could incur judgments or enter into settlements of claims that could have a material adverse effect on our results of operations in any particular period.
Litigation & Legal Liabilities - Risk 2
Providing contract research services creates a risk of liability.
We could be held liable for errors and omissions in connection with the services we perform or the reporting we provide to our clients, which may compromise a study or data from a study or cause the data to be incomplete. Further, we could be held liable for any failure to appropriately care for our clients' property including, among other things, research models, samples, compounds or records. The occurrence of these risks could result in us having to pay damages or incur other costs.
Taxation & Government Incentives2 | 4.8%
Taxation & Government Incentives - Risk 1
Some of our clients and contracts depend on government funding of research and development, and a reduction in that funding may adversely affect our business.
A significant portion of our sales are derived from clients at academic institutions and research laboratories whose funding is partially dependent on funding from government sources, including the National Institutes of Health and U.K./E.U. equivalents. Such funding can be difficult to forecast as government research and development funding is subject to political and budgetary uncertainties, which can delay client purchases or reduce demand for our products and services. Our sales may be adversely affected if our clients delay projects, studies or purchases as a result of uncertainties surrounding the approval of government budget proposals. There can be no certainty that government research funding that is approved will be directed towards projects and studies that involve use of our products and services. Direct cuts to agency budgets or shifts in funding priorities away from areas using our offerings have in the past, and could in the future, negatively affect our business, revenue and financial results.
Taxation & Government Incentives - Risk 2
Changes in funding or disruptions at the U.S. Food and Drug Administration (the "FDA") and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, authorized or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could adversely impact our business.
The ability of the FDA to review and provide marketing authorization for new products or changes to existing products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA's ability to hire and retain key personnel and accept the payment of user fees, federal government shutdowns, and other events that may otherwise affect the FDA's ability to perform routine functions. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Decreases in government funding of research and development, including any reductions in funding to the NIH, may impact our business, as could changes in government programs that provide funding to research institutions and companies, including changes in the amount of funds allocated to different areas of research or changes that have the effect of increasing the length of time of the funding process. Disruptions at the FDA and such other agencies may also slow the time necessary for new products, or modifications to authorized products, to be reviewed and/or authorized by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, during the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points. If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could adversely affect our business.
Environmental / Social4 | 9.5%
Environmental / Social - Risk 1
If we fail to comply with data privacy and security laws and regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
Many U.S. and foreign jurisdictions have passed, or are currently contemplating, a variety of data privacy and cyber and data security laws and regulations. For example, U.S. Department of Health and Human Services regulations under the HIPAA demand compliance with patient privacy and confidentiality requirements. We are also subject to federal, state and international data privacy and security laws and regulations that govern the collection, use, disclosure, transfer, storage, location, disposal and protection of health-related and other personal information, including that of employees. In addition to U.S. federal laws and regulations, a number of U.S. states have also enacted data privacy and security laws and regulations that govern the collection, use, disclosure, transfer, storage, disposal, and protection of personal information. Internationally, virtually every jurisdiction in which we operate has established its own data privacy and security legal framework with which we must comply. The legislative and regulatory framework for privacy and data protection issues worldwide is rapidly evolving as countries continue to adopt privacy and data security laws that may apply to us, both because our operations are located in those countries and/or because we provide services to customers in those countries. The interpretation and enforcement of the laws and regulations described above are uncertain and subject to change, and may require substantial costs to monitor and implement compliance with any additional requirements. Failure to comply with U.S. and international data protection laws and regulations, and the disclosure of any data or related breach, could result in government enforcement actions (which could include substantial civil and/or criminal penalties and injunctive relief), private litigation and/or adverse publicity. For example, we are in the process of providing notifications regarding the 2025 Cybersecurity Incident in accordance with applicable legal obligations. Further, following the 2025 Cybersecurity Incident, we were named as a defendant in the Privacy Class Actions, each of which seeks monetary and injunctive relief. Depending on future developments, we could face additional claims, governmental investigations or enforcement actions, and other related costs and expenditures, any of which could have an adverse effect on our business, financial condition or results of operations.
Environmental / Social - Risk 2
We are subject to environmental, health and safety requirements and risks as a result of which we may incur significant costs, liabilities and obligations.
We are subject to a variety of federal, state, local and foreign environmental laws, regulations, initiatives and permits that govern, among other things: the emission and discharge of materials, including greenhouse gases, in air, land and water; the remediation of soil, surface water and groundwater contamination; the generation, storage, handling, use, disposal and transportation of regulated materials and wastes, including biomedical and radioactive wastes; and health and safety. Failure to comply with these laws, regulations or permits could result in fines or sanctions, obligations to investigate or remediate existing or potential contamination, third-party property damage claims, personal injury claims, natural resource damages claims or modification or revocation of operating permits and/or licenses, debarment and/or may lead to temporary or permanent business interruptions. Pursuant to certain environmental laws, we may be held strictly, and under certain circumstances jointly and severally, liable for costs of investigation and remediation of contaminated sites which we currently own or operate, or sites we or our predecessors have owned or operated in the past. Further, we could be held liable at sites where we have sent waste for disposal. Environmental laws, regulations and permits, and the enforcement thereof, change frequently and have tended to become more stringent over time. Compliance with the requirements of laws and regulations may increase capital costs and operating expenses or necessitate changes to our production processes. We use, and in the past have used, hazardous materials and generate, and in the past have generated, hazardous wastes. We cannot eliminate the risk of accidental contamination or injury from these materials. In the event of such an accident, we could be held liable for any resulting damages and incur liabilities which could exceed our resources. Our costs, liabilities and obligations relating to environmental matters may have a material adverse effect on our business, financial condition, prospects, results of operations and cash flows. For further information, see Note 15 - Contingencies and Commitments to the consolidated financial statements contained in Part II, Item 8.
Environmental / Social - Risk 3
Actions of animal rights activists may affect our business.
Products and services of the type we provide are required for the registration of pharmaceutical products under regulatory auspices in the United States, Europe and other countries. Many CROs, animal breeders, biopharmaceutical companies and other research organizations have been targeted by animal rights activists that oppose all testing on animals, for whatever purpose, including the animal testing activities in support of safety and efficacy testing for drug development. These groups, which include groups directed at the industry and us, have publicly stated that the goal of their campaign is to stop animal testing. Acts of vandalism and other acts by animal rights activists who object to the use of animals in product development could have a material adverse effect on our business. These groups have historically targeted CROs, animal breeders, academic institutions and biopharmaceutical companies, but also third parties that do business with those organizations, including clients, suppliers, advisors, financial advisors, lenders and investors.
Environmental / Social - Risk 4
Our business uses biological and hazardous materials, which could injure people or violate laws, resulting in liability that could adversely impact our financial condition and business.
Our activities involve the controlled use of potentially harmful biological materials, as well as hazardous materials, chemicals and various radioactive compounds. We cannot completely eliminate the risk of accidental contamination or injury from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for damages that result, and any liability could exceed our insurance coverage and ability to pay. Any contamination or injury could also damage our reputation, which is critical to obtaining new business. In addition, we are subject to federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations is significant and if changes are made to impose additional requirements, these costs could increase and have an adverse impact on our financial condition and results of operations.
Ability to Sell
Total Risks: 6/42 (14%)Above Sector Average
Competition1 | 2.4%
Competition - Risk 1
We operate in a highly competitive industry.
The contract research services industry is highly competitive. We often compete for business not only with other CROs, but also with internal discovery and development departments within our client companies. Several of our competitors have significantly greater financial, marketing, technical or other resources and a larger global footprint than we have. The industry has historically been diverse with more than 1,000 CROs around the globe, ranging from small, regional niche laboratories up to global comprehensive service providers with tens of thousands of employees. The contract research services industry has experienced consolidation in recent years. This trend is likely to produce more competition among the larger companies for both clients and acquisition candidates. Offshore CROs have provided increasing competitive pressures. The RMS industry is highly competitive. Competition ranges from academics and large biopharmaceutical companies, that derive and maintain their own rodent colonies, to commercial competitors that may offer a similar or overlapping range of products and/or services. Some of these competitors have greater capital, technical and other resources than we have, while other competitors that are smaller specialized companies might compete effectively against us based on price and their concentrated size and focus. If we do not compete successfully, our business will suffer. Increased competition might lead to price and other concessions that could adversely affect our operating results.
Demand3 | 7.1%
Demand - Risk 1
We rely on a limited number of key clients, the importance of which may vary dramatically from year to year, and a loss of one or more of these key clients may adversely affect our operating results.
One client related to the RMS segment accounted for approximately 16.6%, 15.9% and 22.0% of our total revenue during fiscal years 2025, 2024 and 2023, respectively. The loss of a significant amount of business from one or more of our major clients would materially and adversely affect our results of operations until such time, if ever, as we are able to replace the lost business. Significant clients or projects in any one period may not continue to be significant clients or projects in other periods. In any given year, there is a possibility that a single client may account for a significant percentage of our total revenue or that our business may depend on one or more large projects. Since we do not have long-term contracts with most of our clients, the importance of a single client may vary dramatically from year to year as projects end and new projects begin. To the extent that we are meaningfully dependent on any single client, we are indirectly subject to risks related to that client, including if such risks impede the client's ability to stay in business or otherwise to make timely payments to us.
Demand - Risk 2
Our business, results of operations, financial condition, including the carrying value of certain of our assets, and cash flows have been, and may continue to be, adversely affected by our dependence on the importation of non-human primates ("NHPs") from suppliers located outside the U.S., particularly from certain countries in Southeast Asia and Africa, legal issues related to these suppliers, increased costs associated with trade and economic factors, including tariffs, and any inability to diversify our suppliers located outside the U.S.
Our business, results of operations, financial condition, including the carrying value of certain of our assets, and cash flows have and may continue to be adversely affected by our dependence on NHP suppliers that are located outside the U.S. and difficulties in being able to diversify our suppliers located outside the U.S. The number of NHP suppliers located outside the U.S. is limited. If we are unable to obtain NHPs in sufficient quantities of the required species or in a timely manner to meet the needs of our clients, if the price of NHPs that are available increases significantly, or if we are unable to ship the NHPs in our possession to our clients because of governmental restrictions or limitations, our business, particularly in our RMS segment, will be materially adversely affected. Conversely, if the number of NHP suppliers which export to the U.S. were to increase, this could impact the pricing environment for NHPs, make it difficult to predict results, lead to variability in volumes and require us to adjust operations. In addition, increases in the costs of NHPs without ratable increased revenue as a result of macroeconomic and other factors, including increased tariffs, export or import laws/restrictions or embargoes, inflation, international trade regulations and foreign government instability, among other circumstances could materially adversely affect our business, financial condition, cash flows and results of operations. Our imported NHPs were subject to tariffs ranging from 10% to 20% during fiscal 2025. These tariffs were required to be paid within 30 days of import, which is a shorter timeframe than the average NHP research model inventory turnover. As a result, payment of tariffs negatively impacted the Company's cash flows during fiscal 2025 and is expected to impact the Company's cash flows in the future. The current and future applicable tariff percentages are based on the country of origin of the imported NHPs. Further, there continues to be a risk of additional and/or increased tariffs in connection with ongoing geopolitical and other factors. Our attempts to mitigate the financial impacts of the additional tariff costs may not be successful in the desired timeframe or at all. Should additional and/or increased tariffs be put into place and exist for some time, our business, financial condition, cash flows and results of operations could be materially adversely affected by the additional costs to us and/or by our clients' prioritization of studies and our suppliers' prioritization and allocation of their supply going forward.
Demand - Risk 3
We are substantially dependent on the pharmaceutical and biotechnology industries.
Our ability to grow and to win new business depends upon the ability and propensity of pharmaceutical and biotechnology companies to purchase the purpose-bred animal research models and products we sell and to outsource the services we provide. Research and development spending fluctuates due to changes in available resources, mergers of pharmaceutical and biotechnology companies, spending priorities and institutional budgetary policies, among other reasons. Accordingly, economic factors and industry trends that affect our clients in these industries also affect our business. Further, decreases in outsourcing practices by our clients may result in reductions in our revenue, particularly in our DSA segment, and may adversely affect our financial condition, results of operations and cash flows. Implementation of healthcare reform legislation, such as certain provisions of the Inflation Reduction Act, may have certain benefits, but also may contain costs that could limit the profits that can be made from the development of new drugs. This could adversely affect research and development expenditures by pharmaceutical and biotechnology companies, which could in turn decrease the business opportunities available to us both in the U.S. and abroad. In addition, new laws or regulations may create a risk of liability, increase our costs or limit our service offerings. Furthermore, if the practices of health insurers were to change with respect to reimbursements for pharmaceutical products, our clients may spend less or reduce their growth in spending on research and development.
Sales & Marketing2 | 4.8%
Sales & Marketing - Risk 1
The majority of our clients' contracts and orders can be terminated upon short notice.
A majority of our contracts for contract research services are terminable by the client upon 30 days' notice and these clients terminate or delay their contracts for a variety of reasons. Further, in general, our clients order research models on an as-needed basis. The size and frequency of those orders can be reduced or eliminated with little or no notice. Client contracts and orders may be negatively impacted for various reasons, including: - products being tested fail to satisfy safety requirements;- products having undesired clinical results;- the client deciding to forego a particular study;- inability to enroll enough patients in the study;- inability to recruit enough investigators;- loss of funding for the particular research study or program;- production problems causing shortages of the drug;- inability to secure research models relevant to the studies; and - actions by regulatory authorities. Although our contract research contracts frequently entitle us to receive the costs of winding down the terminated projects, as well as all fees earned by us up to the time of termination, and some of our contracts entitle us to a termination fee, the loss, reduction in scope or delay of a large contract or order, or the loss or delay of multiple contracts or orders, could materially adversely affect our business.
Sales & Marketing - Risk 2
Our sales of NHPs have decreased significantly in recent periods, which adversely affected our business, financial condition and results of operations, and this trend may continue.
The preclinical research industry faced challenges and volatility resulting from the USAO-SDFL criminally charging employees of our then-principal supplier of NHPs in November 2022, and the subsequent decline in imports of Cambodian NHPs to the U.S. beginning in late 2022. The decrease in overall NHP supply drove an increase in NHP pricing in fiscal 2023. During fiscal 2024, both the cost of obtaining and the sale price of NHPs decreased. Further, during certain periods presented within this Annual Report on Form 10-K, we believe some NHP customers may have been working towards reducing some owned inventory and aligning their NHP purchases more closely with their immediate needs rather than purchasing historical levels of NHPs. We also believe the decreased U.S. NHP supply caused some studies to be shifted outside of the U.S. In recent years, the Company's RMS segment revenue has experienced volatility. If the Company's results of operations in the twelve months following this report do not improve relative to its fiscal 2025 results do not increase, it would have an adverse effect on the Company's business financial condition and results of operations, and could result in non-compliance with the financial covenants under the Company's Credit Agreement, as discussed elsewhere in this "Risk Factors" section.
Macro & Political
Total Risks: 6/42 (14%)Above Sector Average
Economy & Political Environment1 | 2.4%
Economy & Political Environment - Risk 1
Unfavorable general economic conditions may materially adversely affect our business.
While it is difficult for us to predict the impact of general economic conditions on our business, these conditions could reduce client demand for some of our products or services, which could cause our revenue to decline. Also, our clients, particularly smaller biotechnology companies which are especially reliant on the credit and capital markets, may not be able to obtain adequate access to credit or equity funding, which could affect their ability to timely pay us. Moreover, we rely on credit facilities to provide working capital to support our operations and regularly evaluate alternative financing sources. Changes in the commercial credit market or in the financial stability of our creditors may impact the ability of our creditors to provide additional financing. In addition, the financial condition of our credit facility providers, which is beyond our control, may adversely change. Any decrease in our access to borrowings under our credit facility or successor facilities (if any), tightening of lending standards and other changes to our sources of liquidity could adversely impact our ability to obtain the financing we need to continue operating our business in the current manner. For these reasons, among others, if economic conditions stagnate or decline, our operating results and financial condition could be adversely affected. Global economic uncertainty has produced, and continues to produce, substantial stress, volatility, illiquidity and disruption of global credit and other financial markets. Various factors contribute to the uncertain economic environment, including geopolitical tensions, military conflicts, the level and volatility of interest rates, the level of inflation, an actual recession or fears of a recession, trade policies and tariffs, and political and governmental instability.
International Operations1 | 2.4%
International Operations - Risk 1
Our non-U.S. operations expose us to risks associated with operating internationally.
During the fiscal years ended September 30, 2025, 2024 and 2023, revenues generated by our facilities outside the U.S. were 12.7%, 14.6% and 15.7%, respectively, of consolidated revenues. As a result of these sales from foreign entities and facilities located outside the U.S., our operations are subject to a variety of risks unique to international operations, including the following: - exposure to local economic conditions;- currency exchange rate and interest rate fluctuations;- differences and changes in tax laws;- potential restrictions on the transfer of funds;- differences in regulatory requirements;- exposure to liabilities under the U.S. Foreign Corrupt Practices Act or the U.K. Antibribery Act;- government imposed investment and other restrictions or requirements;- failure to comply with new and evolving regulations, including privacy and security laws;- exposure to local social unrest, including any resulting acts of war, terrorism or similar events;- exposure to local public health issues and the resulting impact on economic and political conditions;- difficulty enforcing agreements and collecting receivables through certain legal systems;- more expansive legal rights of employees, including specifically those applicable to our European operations;- variations in protection of intellectual property and other legal rights; and - export and import and trade restrictions (such as antidumping duties, tariffs or embargoes).
Natural and Human Disruptions3 | 7.1%
Natural and Human Disruptions - Risk 1
Our business, results of operations, financial condition, including the carrying value of certain of our assets, cash flows and stock price have and may in the future be adversely affected by pandemics, epidemics or other public health emergencies.
Our business, results of operations, financial condition, including the carrying value of certain of our assets, cash flows and stock price have and may in the future be adversely affected by pandemics, epidemics or other public health emergencies. Such health emergencies can result in governments around the world implementing stringent measures to help control the spread of the virus, including quarantines, "shelter in place" and "stay at home" orders, travel restrictions, business curtailments, school closures, and other measures. The outbreak of public health emergencies and preventive or protective actions taken by governmental authorities have had, and may in the future have, a material adverse effect on our and our clients' and suppliers' respective operations, including with respect to the potential for business shutdowns or disruptions. The extent to which these health emergencies may continue to adversely impact our business depends on future developments, which are highly uncertain and unpredictable, depending upon the severity and duration of the emergency and the effectiveness of actions taken globally to contain or mitigate its effects. Future financial impact cannot be estimated reasonably at this time, but may materially adversely affect our business, results of operations, financial condition, including the carrying value of certain of our assets, and cash flows. Even after public health emergencies have subsided, we may experience materially adverse impacts to our business due to any resulting economic recession or depression and demand for our products and services. Additionally, concerns over the economic impact of public health emergencies have caused extreme volatility in financial and other capital markets which has and may in the future adversely impact our stock price and our ability to access capital markets including to refinance existing obligations. To the extent public health emergencies adversely affect our business and financial results, they may also have the effect of exacerbating many of the other risks described herein or other risks not presently known to us or that we currently deem immaterial.
Natural and Human Disruptions - Risk 2
Our animal populations may suffer diseases that can damage our inventory, harm our reputation, result in decreased sales of our services or research products or result in other liability.
It is important that our animal populations be free of diseases, including infectious diseases. The presence and prevalence of diseases can distort or compromise the quality of research results, can cause substantial loss of animals in our inventory, can result in harm to humans or outside animal populations if the disease is not contained to animals in inventory, or can result in other losses. These risks may differ substantially according to species. In rodents, most infections are without any apparent clinical signs and therefore pose a risk to the scientific quality of the research performed on the animals rather than to humans. In NHPs, the main concern is the potential for zoonotic infectious diseases to cause harm to humans. We have in the past suffered disease in our animal populations and may suffer outbreaks in the future. If disease or contamination occurs in our animal population, it typically requires remediation and cleanup activities that are costly and time consuming. In certain circumstances, it can require extended quarantine periods or temporary or permanent closure of an affected facility. We have experienced such closures in the past and may do so again in the future. Any significant disease outbreak has the potential to harm our reputation or have a material adverse effect on our financial condition, results of operations, and cash flows. There is also the risk that disease from research models we produce may affect our clients' facilities and may result in an affected client requesting compensation for damages. While we endeavor to include provisions in our sale and supply contracts which entitle us to be indemnified or entitle us to a limitation of liability, these provisions do not uniformly protect us against liability arising from certain of our own actions, such as negligence or misconduct. Moreover, in certain circumstances, we may agree to use contracts drafted by our clients, which may not contain clauses that indemnify us or limit our liability. We could be materially adversely affected if we were required to pay damages or bear the costs of defending any claim which is not covered by a contractual indemnification provision or in the event that a party who must indemnify us does not fulfill its indemnification obligations or which is beyond the level of our insurance coverage or for which insurance coverage is not available. There can be no assurance that we will be able to maintain insurance coverage on terms acceptable to us.
Natural and Human Disruptions - Risk 3
We have identified conditions and events that could raise substantial doubt about our ability to continue as a going concern.
We have identified certain conditions or events, which are discussed below, that could raise substantial doubt about our ability to continue as a going concern. As a result of these and as disclosed elsewhere in this report, substantial doubt about the Company's ability to continue as a going concern exists. During the fiscal year ended September 30, 2025, revenue and operating loss were $513,024 and $30,902, respectively, as compared to $490,739 and $86,406, respectively, in the fiscal year ended September 30, 2024. The Company had negative operating cash flows, operating losses and net losses in both years. As of September 30, 2025, the Company has cash and cash equivalents of $21,741 and access to a $15,000 revolving credit facility, which had a $3,000 balance outstanding as of September 30, 2025. The Company was in compliance with its financial covenants under its Credit Agreement as of September 30, 2025. If the Company's results of operations in the twelve months following the date of this report do not improve relative to its fiscal 2025 results, the Company will be at risk of non-compliance with its financial covenants under its Credit Agreement. Further, the Company's Term Loan Facility, Delayed Draw Term Loan and Incremental Term Loans mature in the next 12 months. Management's fiscal 2026 annual operating plan forecasts noncompliance with its financial covenants under the Credit Agreement. If at any time in the twelve months following the date of this report, the Company fails to comply with its financial covenants which remains unremedied for the period of time stipulated under the Credit Agreement, this would constitute an event of default under the Credit Agreement and the lenders may, among other remedies set out under the Credit Agreement, declare all or any portion of the outstanding principal amount of the borrowings (which include the term loans) plus accrued and unpaid interest to be immediately due and payable. Furthermore, if the lenders were to accelerate the loans under the Credit Agreement, such acceleration would constitute a default under our indentures governing the Company's Convertible Senior Notes (the "Notes") and the Company's 15.00% Senior Secured Second Lien PIK Notes due 2027 (the "Second Lien Notes") which, if not cured within 30 days following notice of such default from such trustees or holders of 25 percent of the Notes and from the trustee or holders of 30 percent of the Second Lien Notes, would permit the trustee or such holders to accelerate the Notes and the Second Lien Notes. If the loans under the Credit Agreement, the Notes and the Second Lien Notes are accelerated, the Company does not believe its existing cash and cash equivalents, together with cash generated from operations, would be sufficient to fund its operations, satisfy its obligations, including cash outflows for planned targeted capital expenditures, and repay the entirety of its outstanding senior term loans, outstanding Notes, outstanding revolving credit facility balance, and outstanding Second Lien Notes in the next twelve months. Additionally, access to the revolver would be restricted and such funds would not be available to pay for any operating activities. Our evaluation of the Company's ability to continue as a going concern in accordance with U.S. generally accepted accounting principles entailed analyzing prospective fully implemented operating budgets and forecasts for expectations of our cash needs and comparing those needs to the current cash and cash equivalent balances in order to satisfy our obligations, including cash outflows for planned targeted capital expenditures, and to comply with minimum liquidity and financial covenant requirements under our debt covenants related to borrowings pursuant to its Credit Agreement for at least the next twelve months. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented and are outside of its control as of the date the consolidated financial statements are issued. When substantial doubt exists under this methodology, we evaluate whether the mitigating effect of our plans sufficiently alleviates substantial doubt about our ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the consolidated financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. As a result of the factors outlined above, substantial doubt about our ability to continue as a going concern exists. In addition, the fact that there is substantial doubt about the Company's ability to continue as a going concern and that the Company is operating under these conditions may adversely affect the Company's stock price, its ability to raise capital, its ability to comply with its Credit Agreement and its normal business operations, among other implications.
Capital Markets1 | 2.4%
Capital Markets - Risk 1
We have experienced periods of losses and financial insecurity.
Throughout our history, we have experienced periods of financial losses and financial hardship. Our current efforts may not result in profitability, or if our efforts result in profits, such profits may not continue for any meaningful period of time. In order to finance various acquisitions, expand certain facilities, resolve certain legal matters, and support our operations, we have significantly increased our leverage. For the fiscal year ended September 30, 2025, the Company had both an operating loss and a net loss, and may continue to experience losses in the future. Sustained losses may result in our inability to service our financial obligations as they come due, to comply with the financial covenants under our Credit Agreement, or to meaningfully invest in our business.
Tech & Innovation
Total Risks: 4/42 (10%)Below Sector Average
Innovation / R&D1 | 2.4%
Innovation / R&D - Risk 1
Our future success may depend on our ability to keep pace with rapid technological changes that could make our services and products less competitive or obsolete.
The biotechnology, pharmaceutical and medical device industries generally, and contract research services more specifically, are subject to increasingly rapid technological changes. Our competitors or others might develop technologies, services or products that are more effective or commercially attractive than our current or future technologies, services or products, or that render our technologies, services or products less competitive or obsolete. If competitors introduce superior technologies, services or products and we cannot make enhancements to our counterparts to remain competitive, our competitive position, and in turn our business, revenues and financial condition, would be materially and adversely affected. Many of our competitors have superior financial and human resources deployed toward research and development efforts. Our relatively constrained financial and human resources may limit our ability to effectively keep pace with relevant technological changes.
Cyber Security1 | 2.4%
Cyber Security - Risk 1
We have experienced and are at risk of further cyber-attacks or other security breaches that could compromise sensitive business information and personal information of employees, clients and others, undermine our ability to operate effectively and expose us to liability, which could cause our business and reputation to suffer.
Cyber-attacks or security breaches have in the past, and may again in the future, compromise confidential information of ours, our employees, our clients and others, cause a disruption in our operations, harm our reputation and expose us to liability, which in turn could negatively impact our business and the value of our common shares. For example, on August 8, 2025, we became aware of a cybersecurity incident affecting certain of our systems and data (the "2025 Cybersecurity Incident"). The forensic investigation of the 2025 Cybersecurity Incident determined that between approximately August 5-8, 2025, a threat actor gained unauthorized access to the Company's systems and may have acquired certain data. The Company is in the process of providing notifications regarding the 2025 Cybersecurity Incident in accordance with applicable legal obligations. While we have identified the likely scope of the incident, the full operational and financial impacts are still being evaluated. Accordingly, we have not yet determined whether the 2025 Cybersecurity Incident is reasonably likely to have a material impact on the Company. There can be no assurance that the 2025 Cybersecurity Incident will not have adverse financial, client-related, employee-related and reputational impacts which may expose us to additional liability. As a routine element of our business, we collect, analyze, and retain substantial amounts of data pertaining to the clinical and non-clinical studies we conduct for our clients. We also maintain other sensitive client information, information regarding intellectual property related to certain of our products and other business-critical information, including personally identifiable information of our employees. Our employees, some of whom have access to such information, have and will likely continue to receive "phishing" e-mails intended to trick recipients into surrendering their usernames and passwords and/or inadvertently installing malicious software onto their computers or networks they are connected to. We cannot completely protect against the possibility that sensitive information may be accessed, publicly disclosed, lost or stolen, via phishing attempts or other circumstances. In addition, cybersecurity threats continue to evolve and become more sophisticated, including through the use of artificial intelligence driven social-engineering and ransomware techniques, which may increase the likelihood or severity of future incidents. We utilize cybersecurity technologies, processes and practices which are designed to protect our networks, computers, programs and data from attack, damage or unauthorized access, but they may not be effective or work as designed, as was the case with the 2025 Cybersecurity Incident. Our contracts with our clients typically contain provisions that require us to keep confidential the information generated from our studies. A cyber-attack could result in a breach of those provisions or other negative outcomes, including legal claims or proceedings, investigations, potential liabilities under laws that protect the privacy of personal information, delays and other impediments to our clients' discovery and development efforts, ransomware demands and related delays, damage to our reputation and a negative impact on our financial results and the value of our common shares. In some cases, a cybersecurity incident may also lead to governmental investigations, litigation or reputational harm, any of which could have an adverse effect on our business, financial condition or results of operations. For example, following the 2025 Cybersecurity Incident, we were named as a defendant in three putative class action lawsuits relating to the 2025 Cybersecurity Incident pending in the United States District Court for the Northern District of Indiana (collectively the "Privacy Class Actions"), each of which seeks monetary and injunctive relief. Depending on future developments, we could face additional claims, governmental investigations or enforcement actions, and other related costs and expenditures, any of which could have an adverse effect on our business, financial condition or results of operations. Our coverage related to our insurance policies, which includes cybersecurity, might not be adequate to compensate us for all losses that may occur. Refer to Note 15 - Contingencies and Commitments in Part II, Item 8 for further discussion of the 2025 Cybersecurity Incident and the Privacy Class Actions.
Technology2 | 4.8%
Technology - Risk 1
Hardware or software failures, delays in the operations of our computer and communications systems or the failure to implement system enhancements have in the past, and could in the future, harm our business.
We operate large and complex computer systems that contain significant amounts of client data. Our success depends on the efficient and uninterrupted operation of our computer and communications systems. A failure of our network or data gathering procedures, including as a result of the 2025 Cybersecurity Incident or similar future incidents, have in the past, and could in the future, impede the processing of data, delivery of databases and services, client orders, product shipments and day-to-day management of our business and have in the past, and could in the future, result in the corruption or loss of data. While we have disaster recovery plans in place for our operations, they might not adequately protect us. Damage from fire, floods, hurricanes, power loss, telecommunications failures, computer viruses, break-ins and similar events at our facilities could result in interruptions in the flow of data to our servers and from our servers to our clients. In addition, failure by our computer environment to provide our required data communications capacity has in the past, and could in the future, result in interruptions in our service. In the event of a delay in the delivery of data, we could be required to transfer our data collection operations to an alternative provider of server hosting services, which may not be available on terms favorable to us or on a timely basis, and could result in delays in our ability to deliver our products and services to our clients. Additionally, significant delays in the planned delivery of system enhancements, improvements and inadequate performance of the systems once they are completed could harm our business. Finally, long-term disruptions in our computer and communications infrastructure caused by events such as natural disasters, the outbreak of war, the escalation of hostilities and acts of terrorism, particularly involving cities in which we have offices, could adversely affect our businesses. Our coverage related to our insurance policies, which includes cybersecurity, might not be adequate to compensate us for all losses that may occur.
Technology - Risk 2
New technologies may be developed, validated and increasingly used in biomedical research that could reduce demand for some of our products and services.
For many years, groups within the scientific and research communities have attempted to develop models, methods and systems that would replace or supplement the use of living animals as test subjects in biomedical research. In addition, technological improvements to existing or new processes, such as imaging and biomarker technology, could result in a refinement in the number of animal research models necessary to conduct the required research. Alternative research methods could decrease the need for research models, and we may not be able to develop new products effectively or in a timely manner to replace any lost sales. In addition, other companies or entities may develop research models with characteristics different than the ones that we produce, and which may be viewed as more desirable by our clients.
Production
Total Risks: 3/42 (7%)Below Sector Average
Employment / Personnel1 | 2.4%
Employment / Personnel - Risk 1
The loss of key personnel could adversely affect our business.
Our success depends to a significant extent upon the efforts of our senior management team and other key personnel. The loss of the services of such personnel could adversely affect our business. Also, because of the nature of our business, our success depends upon our ability to attract, train, manage and retain qualified personnel. There is substantial competition for qualified personnel, and an inability to recruit or retain qualified personnel may impact our ability to grow our business and compete effectively in our industry.
Supply Chain1 | 2.4%
Supply Chain - Risk 1
We rely on third parties for important services.
We have historically depended on third parties to provide us with services critical to our business. The failure of third parties to adequately provide needed services or our determination to forgo non-critical services, could have a material adverse effect on our business.
Costs1 | 2.4%
Costs - Risk 1
We may bear financial risk if we underprice our contracts or overrun cost estimates.
Since some of our contracts are structured as fixed price or fee-for-service, we bear the financial risk if we initially underprice our contracts or otherwise overrun our cost estimates. Significant underpricing or cost overruns could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
See a full breakdown of risk according to category and subcategory. The list starts with the category with the most risk. Click on subcategories to read relevant extracts from the most recent report.

FAQ

What are “Risk Factors”?
Risk factors are any situations or occurrences that could make investing in a company risky.
    The Securities and Exchange Commission (SEC) requires that publicly traded companies disclose their most significant risk factors. This is so that potential investors can consider any risks before they make an investment.
      They also offer companies protection, as a company can use risk factors as liability protection. This could happen if a company underperforms and investors take legal action as a result.
        It is worth noting that smaller companies, that is those with a public float of under $75 million on the last business day, do not have to include risk factors in their 10-K and 10-Q forms, although some may choose to do so.
          How do companies disclose their risk factors?
          Publicly traded companies initially disclose their risk factors to the SEC through their S-1 filings as part of the IPO process.
            Additionally, companies must provide a complete list of risk factors in their Annual Reports (Form 10-K) or (Form 20-F) for “foreign private issuers”.
              Quarterly Reports also include a section on risk factors (Form 10-Q) where companies are only required to update any changes since the previous report.
                According to the SEC, risk factors should be reported concisely, logically and in “plain English” so investors can understand them.
                  How can I use TipRanks risk factors in my stock research?
                  Use the Risk Factors tab to get data about the risk factors of any company in which you are considering investing.
                    You can easily see the most significant risks a company is facing. Additionally, you can find out which risk factors a company has added, removed or adjusted since its previous disclosure. You can also see how a company’s risk factors compare to others in its sector.
                      Without reading company reports or participating in conference calls, you would most likely not have access to this sort of information, which is usually not included in press releases or other public announcements.
                        A simplified analysis of risk factors is unique to TipRanks.
                          What are all the risk factor categories?
                          TipRanks has identified 6 major categories of risk factors and a number of subcategories for each. You can see how these categories are broken down in the list below.
                          1. Financial & Corporate
                          • Accounting & Financial Operations - risks related to accounting loss, value of intangible assets, financial statements, value of intangible assets, financial reporting, estimates, guidance, company profitability, dividends, fluctuating results.
                          • Share Price & Shareholder Rights – risks related to things that impact share prices and the rights of shareholders, including analyst ratings, major shareholder activity, trade volatility, liquidity of shares, anti-takeover provisions, international listing, dual listing.
                          • Debt & Financing – risks related to debt, funding, financing and interest rates, financial investments.
                          • Corporate Activity and Growth – risks related to restructuring, M&As, joint ventures, execution of corporate strategy, strategic alliances.
                          2. Legal & Regulatory
                          • Litigation and Legal Liabilities – risks related to litigation/ lawsuits against the company.
                          • Regulation – risks related to compliance, GDPR, and new legislation.
                          • Environmental / Social – risks related to environmental regulation and to data privacy.
                          • Taxation & Government Incentives – risks related to taxation and changes in government incentives.
                          3. Production
                          • Costs – risks related to costs of production including commodity prices, future contracts, inventory.
                          • Supply Chain – risks related to the company’s suppliers.
                          • Manufacturing – risks related to the company’s manufacturing process including product quality and product recalls.
                          • Human Capital – risks related to recruitment, training and retention of key employees, employee relationships & unions labor disputes, pension, and post retirement benefits, medical, health and welfare benefits, employee misconduct, employee litigation.
                          4. Technology & Innovation
                          • Innovation / R&D – risks related to innovation and new product development.
                          • Technology – risks related to the company’s reliance on technology.
                          • Cyber Security – risks related to securing the company’s digital assets and from cyber attacks.
                          • Trade Secrets & Patents – risks related to the company’s ability to protect its intellectual property and to infringement claims against the company as well as piracy and unlicensed copying.
                          5. Ability to Sell
                          • Demand – risks related to the demand of the company’s goods and services including seasonality, reliance on key customers.
                          • Competition – risks related to the company’s competition including substitutes.
                          • Sales & Marketing – risks related to sales, marketing, and distribution channels, pricing, and market penetration.
                          • Brand & Reputation – risks related to the company’s brand and reputation.
                          6. Macro & Political
                          • Economy & Political Environment – risks related to changes in economic and political conditions.
                          • Natural and Human Disruptions – risks related to catastrophes, floods, storms, terror, earthquakes, coronavirus pandemic/COVID-19.
                          • International Operations – risks related to the global nature of the company.
                          • Capital Markets – risks related to exchange rates and trade, cryptocurrency.