PAHC Phibro Animal Health Corporation

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): November 7, 2023

 

Phibro Animal Health Corporation

(EXACT NAME OF REGISTRANT AS SPECIFIED IN CHARTER)

 

Delaware		01-36410		13-1840497
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

Glenpointe Centre East, 3rd Floor

300 Frank W. Burr Boulevard, Suite 21

Teaneck, New Jersey 07666-6712

(Address of Principal Executive Offices, including Zip Code)

 

(201) 329-7300

(Registrant’s telephone number, including area code)

 

Not Applicable

(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
Class A Common Stock, $0.0001 par value per share		PAHC		NASDAQ Stock Market

 

Check the appropriate box below if this 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 Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

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 7.01

REGULATION FD DISCLOSURE

 

On November 7, 2023, Phibro Animal Health Corporation (“Phibro”) issued a press release regarding the Food and Drug Administration’s intention to take a number of actions related to its ongoing review of the regulatory status of Mecadox® and reiterating Phibro’s intent to defend the safety and continued use of Mecadox for its customers. Sales of Mecadox for the year ended June 30, 2023, were approximately $20 million. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information contained in the press release is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of, or otherwise regarded as filed under, the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

ITEM 9.01

FINANCIAL STATEMENTS AND EXHIBITS.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release, dated November 7, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

SIGNATURES

 

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 thereunto duly authorized.

 

	PHIBRO ANIMAL HEALTH CORPORATION Registrant
Date: November 7, 2023
	By:	/s/ Judith Weinstein
	Name:  Title:	Judith Weinstein Senior Vice President, General Counsel and Corporate Secretary

 

Exhibit 99.1

 

 

 

 

For Immediate Release

 

Phibro Animal Health Corporation Reiterates Safety of Mecadox® and Intent to Defend its Use for Customers

 

TEANECK, NJ, November 7, 2023 (Business Wire) -- (NASDAQ:PAHC) The Food and Drug Administration (FDA), through its Center for Veterinary Medicine (CVM), has taken two actions regarding Mecadox^® (carbadox), a drug marketed by Phibro Animal Health Corporation.

 

In the first action, FDA has provided notice of a Federal Register publication issuing a final order to revoke the approved method for detecting residues of carbadox. FDA has also provided notice of a second Federal Register publication proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed and announcing an opportunity for Phibro to request a hearing on this proposal. This second action is based on CVM’s determination that there is no approved regulatory method to detect carbadox residues in the edible tissues of the treated swine.

 

Phibro is extremely disappointed in the actions taken by the FDA and believes fully in the safety of Mecadox. Mecadox (carbadox) has been approved and sold in the United States for more than 50 years and is a widely used treatment for controlling bacterial diseases in swine, including Salmonella and swine dysentery, resulting in improved health and welfare for newly born and young pigs.

 

Today’s steps are the latest in a long history of attempted measures taken by the FDA relating to carbadox that we do not believe are based on solid science. In 2016, the FDA set in motion the initial steps in a process to rescind its approval of carbadox based on its stated concerns about the persistence of carcinogenic residues. Phibro requested a hearing, and over the next four years continued an ongoing process of responding collaboratively and transparently to FDA’s inquiries to provide extensive and meticulous research and data confirming the safety of carbadox. In July 2020, FDA voluntarily dismissed the 2016 proceeding and initiated a new process for review of the carbadox regulatory method, instead of following its own procedure and moving forward with a hearing that would resolve the parties’ differing interpretations of the science supporting the safety of carbadox. While Phibro has continuously offered to meet with FDA to discuss the regulatory method and has offered viable alternative methods currently being used in other countries, it is clear that, instead, the FDA is ignoring the long history of safety that Phibro has established and reaffirmed through its most recent studies. As the FDA publicly stated, going after the regulatory method “is the most straightforward and least resource-intensive process for removing carbadox from the market.”

 

Phibro believes carbadox’s 50+ year history of safe use and unparalleled therapeutic efficacy, which has significant animal health and welfare implications, supports its continued use. Phibro will take appropriate action and next steps to continue to defend swine producers’ ability to use Mecadox to protect the health and welfare of their animals.

 

About Phibro Animal Health Corporation

 

Phibro Animal Health Corporation is a leading global diversified animal health and nutrition company. We strive to be a trusted partner with livestock producers, farmers, veterinarians and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. For further information, please visit www.pahc.com.

 

Contact:

Richard Johnson

Chief Financial Officer, Phibro Animal Health Corporation

+1 201-329-7300

or

investor.relations@pahc.com

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Document Type	8-K
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Document Period End Date	Nov. 07, 2023
Entity File Number	01-36410
Entity Registrant Name	Phibro Animal Health Corporation
Entity Central Index Key	0001069899
Entity Tax Identification Number	13-1840497
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	Glenpointe Centre East, 3rd Floor
Entity Address, Address Line Two	300 Frank W. Burr Boulevard, Suite 21
Entity Address, City or Town	Teaneck
Entity Address, State or Province	NJ
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Class A Common Stock, $0.0001 par value per share
Trading Symbol	PAHC
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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