8-K
Phibro Animal Health Corp (PAHC)
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UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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, includingZip Code)
(201
)
329-7300
(Registrant’s telephone number, includingarea code)
Not Applicable
(Former name or former address, if changedsince last report)
Securities registeredpursuant 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement<br> 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<br><br> Registrant | ||
|---|---|---|
| Date: November 7, 2023 | ||
| By: | /s/ Judith Weinstein | |
| Name: <br> Title: | Judith Weinstein<br> Senior Vice President, General Counsel<br> and Corporate Secretary |
Exhibit 99.1
For Immediate Release
Phibro Animal Health Corporation ReiteratesSafety 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