AMAG PHARMACEUTICALS,INC. (NASDAQ:AMAG) Files An 8-K Regulation FD DisclosureItem 7.01 Regulation FD Disclosure.
On June 25, 2018, AMAG Pharmaceuticals, Inc. (“AMAG” or the “Company”) announced that it intends to launch an authorized generic version of the single-dose intramuscular formulation of Makena® (hydroxyprogesterone caproate injection) into the U.S. market, through its generic partner, Prasco Laboratories (“Prasco”). The Company had previously entered into an agreement with Prasco so that it would be prepared to launch its own authorized generic upon the first entry of a generic Makena product, which AMAG now believes is forthcoming given the recent approval by the U.S. Food and Drug Administration of one generic version of the single-dose intramuscular form. Prasco has product inventory available and will commence contracting and shipping product as soon as authorized by AMAG upon launch of a generic product. A mid-year approval and launch of a generic was anticipated in the Company’s 2018 revenue, operating loss and non-GAAP adjusted EBITDA guidance previously disclosed in May 2018. As a result of this partnership, AMAG will be able to provide patients and healthcare providers with access to a therapeutically equivalentversion of the branded Makena intramuscular injection.
AMAG also recently launched a Makena subcutaneous auto-injector. The prefilled Makena auto-injector offers an alternative administration option for patients and providers and contains a shorter, thinner non-visible needle compared to the intramuscular Makena injection. Based on the most recent weekly data, approximately 60% of all new patient enrollments through the Makena Care Connection® have been for the Makena subcutaneous auto-injector. Makena and its authorized generic version are indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.
Forward-Looking Statements
This report contains forward-looking statements 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 for generic competition, the Company’s generic launch, including timing, patient access, and the impact on forecasted revenues, operating loss and non-GAAP adjusted EBITDA, 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, the possibility that additional generics will enter the market, that AMAG and/or Prasco will not be able to successfully commercialize their generic product, that the impact on Makena revenues will be different than expected and the possibility that the Company will not be able to continue to successfully commercialize the subcutaneous auto-injector or meet demand for its products, as well as those risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form10-K for the year ended December31, 2017 and subsequent filings with the SEC. Any such risks and uncertainties could materially and adversely affect the Company’s results of operations, its projections, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on the Company’s stock price. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company 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.
AMAG Pharmaceuticals® is a registered trademark of the Company. Makena® and Makena Care Connection® are registered trademarks of AMAG Pharma USA,Inc.
About AMAG PHARMACEUTICALS,INC. (NASDAQ:AMAG)
AMAG Pharmaceuticals, Inc. is a pharmaceutical company. The Company’s segment is the manufacture, development and commercialization of products and services for use in treating various conditions, with a focus on maternal health, anemia management and cancer supportive care. Its offerings focus on maternal health, anemia management and cancer supportive care, including its product, Makena (hydroxyprogesterone caproate injection); services related to the collection, processing and storage of umbilical cord blood stem cell and cord tissue units operated through Cord Blood Registry (CBR); its product, Feraheme (ferumoxytol), for intravenous (IV) use, and MuGard Mucoadhesive Oral Wound Rinse. It is engaged in the development of Digoxin immune fab, a polyclonal antibody for the treatment of severe preeclampsia in pregnant women. Makena is a drug indicated to reduce the risk of preterm birth in women pregnant with a single baby having a history of singleton spontaneous preterm birth.
