SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): October 5, 2020
AMAG PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
|1100 Winter Street,||Waltham,||Massachusetts|
|(Address of Principal Executive Offices)||(Zip Code)|
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
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))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.01 per share||AMAG||NASDAQ Global Select Market|
Indicate by check mark whether the registrant is an emerging growth company 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 7.01. Regulation FD Disclosure.
On October 5, 2020, AMAG Pharmaceuticals, Inc. (“AMAG,” “we” or the “Company”), issued a press release, a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On October 5, 2020, we received from the Center for Drug Evaluation and Research (“CDER”) of the Food and Drug Administration (“FDA”) a proposal to withdraw marketing approval of Makena (hydroxyprogesterone caproate injection) and notice of opportunity for a hearing (the “Notice”).
The Notice provides AMAG with the opportunity to request a hearing within 15 days of receipt of the Notice and invites holders of the approved generics of Makena to submit comments. If AMAG files a timely request for a hearing, we must, within 30 days of receipt of the Notice, submit data, information and analyses to demonstrate that there is a genuine and substantial issue of material fact that requires a hearing. The FDA Commissioner would decide whether to grant AMAG’s request for a hearing and, if granted, would conduct such hearing and thereafter decide whether to withdraw approval of Makena.
The Makena label remains unchanged and during the pendency of this process, which the FDA has indicated in the frequently asked questions referred to in CDER’s statement published on October 5, 2020 can take months if a hearing is pursued, Makena and the approved generic formulations of Makena will remain on the market until the Commissioner makes a final decision about these products. AMAG is evaluating the full range of potential options.
Forward Looking Statements
This report contains forward-looking information about AMAG within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, expectations about the path forward for Makena and our interactions with the FDA, as well as our plans following receipt of the Notice, including the possibility of requesting a hearing and the timeline for the process, including that Makena will remain on the market are based on management’s current expectations and beliefs and are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, risks and uncertainties related to the path forward for Makena and our ability to successfully and timely request a hearing and compile information that might be helpful to the FDA; the possibility that our request for a hearing could be denied, or that the FDA will withdraw marketing approval for Makena even following such a hearing, the pursuit and planning of which could be costly and distracting to management; and those other risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2019 (as amended), its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarters ended March 31, 2020 and June 30, 2020, and in any subsequent filings with the SEC, which are available at the SEC’s website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
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.
|AMAG PHARMACEUTICALS, INC.|
/s/ Joseph D. Vittiglio
|Joseph D. Vittiglio|
Executive Vice President, General Counsel, Chief Business Officer & Corporate Secretary
|Dated:||October 5, 2020|