Full Press Release Details
Inotiv, Inc. Provides Business Update and
Select Preliminary Fiscal Year 2022
Delays Release of Full Financial
Fourth Quarter and Fiscal Year Ended
WEST LAFAYETTE, IN - December 12, 2022
-- Inotiv, Inc. (NASDAQ: NOTV) (the "Company", "We", "Our" or "Inotiv"), a
leading contract research organization specializing in nonclinical and analytical drug discovery and development services and research
models and related products and services, announced today that it will delay the release and conference call related to its financial
results for the fourth quarter and fiscal year ended September 30, 2022 ("FY 2022") that was originally scheduled for after
As previously disclosed, on November 16, 2022,
the Company became aware that the U.S. Attorney's Office for the Southern District of Florida ("USAO-SDFL") had criminally
charged employees of the Company's principal supplier (the "Supplier") of non-human primates ("NHPs"),
along with two Cambodian officials, with conspiring to illegally import NHPs into the U.S.
from December 2017 through January 2022 and in connection with seven specific imports between July 2018 and December 2021. Also as previously
disclosed, two of the Company's subsidiaries, Orient BioResource Center and Envigo Global Services, Inc., companies acquired
by the Company on January 27, 2022 and November 5, 2021, respectively, had received grand jury subpoenas from USAO-SDFL requiring
the production of documents and information related to their importation of NHPs into the U.S. The Company has been fully cooperating,
and will continue to cooperate, with USAO-SDFL.
of these events, the Company requires additional time to complete the financial statement closing process for FY 2022. The Company intends
to file a Form 12b-25 with the U.S. Securities and Exchange Commission providing the Company a 15-day extension to file its FY 2022 Annual
Report on Form 10-K.
is providing the following preliminary financial data for FY 2022:
| Total revenue for FY 2022 is expected to increase to approximately $547.7 million from total revenue of $89.6 million in FY 2021. | ||
| Discovery and Safety Assessment ("DSA") business book to bill ratio is expected to be 1.33x. | ||
| DSA backlog is expected to increase to approximately $147.2 million at September 30, 2022, up from $81.4 million at September 30, 2021. |
These expectations are preliminary and are subject
to the completion of year-end accounting and financial reporting and audit procedures.
Since learning of the issues related to the Supplier,
the Company has been focused on attempting to obtain additional information, assessing the impact on its NHP sale activities, communicating
with its customers and lenders, and exploring all potential avenues to address this situation. While the situation is extremely fluid
and continues to involve significant uncertainty, the Company would like to address what it expects are questions from its stakeholders.
How significant is the Cambodian supply
of NHPs to U.S. Drug Discovery and Development?
According to the U.S.
Centers for Disease Control and Prevention, in the twelve months ended September 30, 2022, approximately 60% of the NHPs imported
into the U.S. were from Cambodia. We believe that, depending on the duration of
restrictions on these imports, drug discovery and development in the U.S. could be materially impacted. NHPs are critical for
scientific research, and are required by international regulatory guidance to develop and evaluate the safety and effectiveness of a
range of life-saving drugs and treatments prior to their assessment in human clinical trials. Historically, the U.S. biomedical
industry has relied on imported NHPs to meet its domestic demand for research and development of new medicines. The Company believes
that other contract research organizations, the pharmaceutical industry, and departments of the U.S. government recognize the
significance of this interruption in the supply chain for NHPs.
What is the Company's position on
use of NHPs in research?
strongly condemns any and all unauthorized trading and importation of any endangered species. With respect to legal trading and
importation, we believe there is a pressing need to reduce the numbers of animals used in drug discovery and research, and replace them
with non-animal alternatives where possible. The Company also recognizes that it will take time to achieve safe methods to do so, and
there will still be the need for NHPs in the foreseeable future.
Therefore, it is of critical
importance to address NHP supply in the U.S. The Company believes there should be a strong focus on reaching stability in the domestic
supply of NHPs to help further U.S. leadership in the development of drugs and therapies. The recent indictment has highlighted and accelerated
the need for more robust importation controls in the immediate future to promote excellence and provide transparency. The Company believes
that a near-term public-private partnership is essential for secure access to NHPs in the U.S., and the Company, through its commitment
to animal welfare and sustainable governance, can be part of that solution. A public-private partnership is essential as well to develop
a longer-term strategy for breeding in the U.S.
What is the status of the Cambodian NHPs
currently in the Company's possession in the U.S.?
The Company has not been
directed to refrain from selling the Cambodian NHPs in its possession in the U.S. However, due
to the allegations contained in the indictment involving the Supplier and the Cambodian Government officials, the Company believes
that it is prudent, at the present time, to refrain from selling or delivering any of its Cambodian NHPs held in the U.S. until the Company's
staff and external experts can evaluate what additionally can be done to satisfy itself that the NHPs in inventory from Cambodia can
be reasonably determined to be purpose-bred. Historically, the Company has relied on the CITES documentation and related processes and
procedures, including release of each import by U.S. Fish and Wildlife Service.
What portion of the Company's sales
have been from NHPs imported from Cambodia?
Of the Company's expected
preliminary total revenue of $547.7 million in FY 2022, approximately $140 million was from
NHPs that it had imported from Cambodia.
Is the Company currently importing any
We have been informed
that Cambodia has currently ceased any exports of NHPs, and therefore we are not currently importing any NHPs from Cambodia.
We do not know when or if they intend to resume allowing shipments or when and if the U.S. Fish and Wildlife Service will allow
shipments. We are importing NHPs from other countries, however, such imports are limited due to insufficient quantities to meet U.S.
demand. Without imports from China (which are currently banned by China) and/or Cambodia, NHP supply to us, and to U.S. customers
generally, will be increasingly limited.
What is the impact on the Company's
The Company is proactively
discussing these matters with its NHP customers. At this time, none of those customers have notified the Company of a contract breach.
NHPs are used in the Company's Research
Models and Services ("RMS") business; what about its DSA business?
On an annualized basis, the
Company uses approximately 5% of its total imported NHPs for its own internal needs in the DSA segment. The Company currently expects
that it will have NHPs from other origins in sufficient quantities to meet the needs of its DSA segment business in fiscal 2023.
Does this impact the Company's European
NHP sales and its NHP service sales?
At this time, the Company
does not expect that these matters will impact its European NHP sales, as it has not been selling Cambodian NHPs in Europe. In
addition, the Company does not anticipate these matters will negatively impact its NHP service sales.
Why have these issues delayed the Company's
reporting of financial results for FY 2022?
Under applicable accounting
and financial reporting rules, certain events that occur after the end of a fiscal quarter can impact reporting of matters as of that
fiscal quarter end. The Company determined that it requires additional time for further evaluation of the relevant current conditions
and events, considered in the aggregate, as well as management's plans that are intended to mitigate those conditions and events.
Furthermore, assessments of whether assets, tangible and intangible, such as goodwill and inventory, are impaired are dependent on several
considerations, which are based in part on information and estimates as of a fiscal quarter end. Therefore, the Company
is in the process of reviewing and assessing these subsequent events, their recent impact on the Company's stock price and
their impact on the carrying value of its assets.
How are these issues impacting the Company's
first fiscal quarter results?
The Company has not delivered