8-K
Phibro Animal Health Corp (PAHC)
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): July 17, 2020
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 changedsince last report)
Securities registered pursuant to Section12(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<br>Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the<br>Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)<br>under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)<br>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 July 17, 2020, Phibro Animal Health Corporation (the “Company”) 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 the safety of Mecadox when used in accordance with its label. The most recent 12 month sales (through June 30, 2020) for Mecadox were approximately $17 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 July 17, 2020 |
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.
| Date: July 17, 2020 | PHIBRO ANIMAL HEALTH CORPORATION | |
|---|---|---|
| By: | /s/ Thomas G. Dagger | |
| Name: <br><br>Title: | Thomas G. Dagger<br><br>Senior Vice President, General Counsel <br><br>and Corporate Secretary |
Exhibit 99.1
Phibro Animal Health Corporation ReiteratesSafety of Mecadox®
TEANECK, NJ, July 17, 2020 (Business Wire) -- (NASDAQ:PAHC) Today, the Food and Drug Administration (FDA) provided notice of Federal Register publication of its intention to take a number of actions related to its ongoing review of the regulatory status of Mecadox® (carbadox). Mecadox has been approved and sold in the United States for more than 45 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.
In 2016, the FDA issued a Notice of Opportunity for Hearing (NOOH) setting in motion the initial steps in a process to rescind its approval of carbadox based on 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 Center for Veterinary Medicine (CVM) inquiries to provide extensive and meticulous research and data that confirm the safety of carbadox.
Phibro believes that the evidence submitted to FDA:
| · | Concludes that no carbadox residues of carcinogenic concern can be detected at the end of the labeled withdrawal period. |
|---|---|
| · | Confirms that carbadox remains a safe drug to control bacterial diseases in swine. |
| --- | --- |
| · | Increases our collective understanding of the drug’s metabolism, residue characterization and depletion. |
| --- | --- |
| · | Reinforces and affirms prior FDA determinations that the use of carbadox is safe as approved. |
| --- | --- |
In the notice published by the FDA, the agency states it does not agree with Phibro’s scientific conclusions and announced a new process for the review of carbadox, 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. Phibro disagrees with the agency’s conclusions and is disappointed that it is taking these steps. Phibro stands ready to discuss alternative regulatory methods if the FDA believes that the current method is inappropriate.
Phibro has requested to the FDA Office of the Commissioner that the agency continue the process it started in 2016 and proceed with a hearing to review the substantial body of data supporting the safety of carbadox. In addition to the science proving the safety of carbadox, Phibro believes the unparalleled therapeutic efficacy, which has significant animal health and welfare implications, supports the continued use of carbadox.
Phibro will continue to defend swine producers’ ability to use Mecadox to protect the health and welfare of their animals. Mecadox continues to be available for use by swine producers.
About Phibro Animal Health Corporation
Phibro Animal Health Corporation is a diversified global developer, manufacturer and supplier of a broad range of animal health and mineral nutrition products for livestock, helping veterinarians and farmers produce healthy, affordable food while using fewer natural resources. For further information, please visit www.pahc.com.
Contacts:
Richard Johnson
Chief Financial Officer, Phibro Animal Health Corporation
+1 201-329-7300