SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction
|(Commission File Number)||(I.R.S. Employer|
|(Address of principal executive offices)||(Zip Code)|
Registrant's telephone number, including
area code: (
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class:||Trading Symbol(s)||Name of each exchange on which registered:|
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
|Item 2.05||COSTS ASSOCIATED WITH EXIT OR DISPOSAL ACTIVITIES|
On June 2, 2022, ANI Pharmaceuticals, Inc. (the “Company”) announced its decision to cease operations at its manufacturing plant located in Oakville, Ontario, Canada as part of ongoing initiatives to capture operational synergies following the Company’s acquisition of Novitium Pharma.
The Oakville manufacturing plant is expected to cease operations by the first quarter of 2023. The Company is unable at this time to make a good faith estimate of the amount of charges and costs that may be incurred in connection with this closure. In accordance with Item 2.05 of Form 8-K, the Company will timely file an amendment to this report upon the determination of such estimates.
|ITEM 7.01||REGULATION FD DISCLOSURE|
On June 2, 2022, the Company issued a press release announcing that it will cease operations at its Oakville, Ontario, Canada manufacturing plant. The press release is furnished as Exhibit 99.1 and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||Press release, dated June 2, 2022, issued by ANI|
|104||Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|ANI PHARMACEUTICALS, INC.|
|By:||/s/ Stephen P. Carey|
|Stephen P. Carey|
|Senior Vice President, Finance and Chief Financial Officer|
|Dated: June 2, 2022|
FOR IMMEDIATE RELEASE
Announces Consolidation of Manufacturing
Network, Capturing Operational Synergies Post Novitium Acquisition
at Oakville, Canada manufacturing plant expected to end by
first quarter 2023 --
-- Action part
of ongoing efforts to drive cost-competitiveness and deliver sustainable
growth for generics business --
estimate of $7 million to $8 million improvement in profitability and cash
flow on annualized basis --
network well positioned to ensure new product launches and supply
continuity for patients and customers --
BAUDETTE, Minn.--(BUSINESS WIRE) – June 2, 2022 – ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that it intends to cease operations at its Oakville, Ontario, Canada manufacturing plant by first quarter 2023. This action is part of ongoing initiatives to capture operational synergies following the Company’s acquisition of Novitium Pharma in November 2021.
ANI remains committed to meeting patient needs and ensuring the continuity of supply of its medicines to patients and customers. The Company will transition the majority of products manufactured or packaged in Oakville to one of its three U.S.-based manufacturing sites. The Company is seeking to find potential buyers for the Oakville site and remains committed to treating employees with fairness and respect.
“Driving cost-competitiveness and efficiencies is imperative for achieving sustainable growth in the U.S. generics industry. Consolidation of our manufacturing network allows ANI to achieve significant cost savings and stay competitive. Our remaining manufacturing sites are well-placed to support our future growth and enable us to continue serving patients in need,” said Nikhil Lalwani, President and CEO of ANI.
ANI expects this action to improve profitability and cash flow by $7 million to $8 million on an annualized basis. The Company is in the process of developing best estimates of expected charges related to acceleration of depreciation, asset impairments, and employee severance and benefit expense and will provide updates when that information is available.
ANI Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin® Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit www.anipharmaceuticals.com.
To the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding when the Company will complete the closure of the Oakville plant, statements regarding the financial impact of ceasing operations at the Oakville plant, statements about the Company’s corporate strategy, future operations, products, financial performance, financial position, operating results and prospects, including plans for sustainable growth, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the costs involved in commercializing Cortrophin Gel; the ability to maintain regulatory approval of the product and maintain sufficiency of the product; the ability to obtain reimbursement from third-party payors for this product; evolving government legislation; risks the Company may face with respect to importing raw materials; the use of single source suppliers and the time it may take to validate and qualify another supplier, if necessary; whether the Company experiences disruptions to its operations resulting from the plant closure; manufacturing difficulties or delays; ANI’s reliance on third parties over which it may not always have full control; increased competition and strategies employed by competitors; the ability to realize benefits anticipated from acquisitions, including, but not limited to, post-close integration activities related to the Novitium Pharma acquisition; costs and regulatory requirements relating to contract manufacturing arrangements; delays or failure in obtaining product approvals from the U.S. Food and Drug Administration; general business and economic conditions, including the ongoing impact of and uncertainties regarding the COVID-19 pandemic; market trends for our products; regulatory environment and changes; and regulatory and other approvals relating to product development and manufacturing, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission.
More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Lisa M. Wilson
In-Site Communications, Inc.
SOURCE: ANI Pharmaceuticals, Inc.