1. WARREN, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve therapeutic problems, today announced the appointment of Julie Krop, M.D., Chief Medical Officer of Freeline Therapeutics (NASDAQ:FRLN), and Marco Taglietti, M.D., Director, President and Chief Executive Officer of SCYNEXIS (NASDAQ:SCYX), to the Board of Directors of the Company effective February 10, 2021. Aquestive also announced the resignation of Douglas K. Bratton from the Board of Directors after more than 17 years of service. Aquestive's Board of Directors will now be comprised of eight Directors, seven of whom…

    WARREN, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve therapeutic problems, today announced the appointment of Julie Krop, M.D., Chief Medical Officer of Freeline Therapeutics (NASDAQ:FRLN), and Marco Taglietti, M.D., Director, President and Chief Executive Officer of SCYNEXIS (NASDAQ:SCYX), to the Board of Directors of the Company effective February 10, 2021. Aquestive also announced the resignation of Douglas K. Bratton from the Board of Directors after more than 17 years of service. Aquestive's Board of Directors will now be comprised of eight Directors, seven of whom are independent. Dr. Krop will serve as a member of the Board's Nominating and Corporate Governance Committee and Dr. Taglietti will serve as a member of the Board's Audit Committee.

    "We are delighted to welcome Julie and Marco as new independent directors to the Aquestive Board of Directors," said Santo Costa, Aquestive's Chairman of the Board. "Their significant expertise in the pharmaceutical and biotechnology industry and impressive backgrounds complement our Board of Directors' skills and experiences. We are confident they will provide valuable perspectives as we continue to execute our strategy and enhance value for the Company's shareholders."

    Dr. Krop stated, "I am thrilled to join the Board of Directors of Aquestive and look forward to working with the Board and the leadership team to advance the Company's mission of providing novel alternatives to invasively administered standard of care therapies. I am particularly excited about helping management guide Aquestive's proprietary orally administered epinephrine through clinical development. This novel formulation of epinephrine has the potential to eliminate the burden of intramuscular or subcutaneous injections for patients at risk of anaphylaxis due to severe allergies."

    Dr. Taglietti commented, "Aquestive is at an important stage of its evolution and I am delighted to join the Board of Directors during this exciting time. I look forward to contributing to Aquestive's continued growth and success as the Company advances its Libervant™ (diazepam) Buccal Film application through approval and executes on its innovative development activities with the potential to change patients' lives."

    "Julie and Marco join Aquestive at an exciting time as we continue to focus on developing and bringing to market valuable products in the CNS and allergy spaces. Julie and Marco's extensive collective experience in leading clinical development, regulatory strategies and commercialization of key value assets is a great addition and complement to the skills already present on our board," remarked Keith Kendall, Director, President and Chief Executive Officer of Aquestive. "We've experienced significant growth and strengthened our capabilities as a commercial pharmaceutical company under Doug's leadership as the original Chairman of the Board and then director. I would like to thank him for his contributions and expert guidance that have well positioned Aquestive for continued momentum and success."

    "On behalf of the Board of Directors and the Company, I would like to thank Doug for his more than 17 years of service to our Board, including as former Chairman, in guiding the Company from its start-up phase to a public commercial pharmaceutical company and leader in the film-based therapeutics industry," said Mr. Costa.

    "It has been a great privilege to serve as a director and former Chairman of Aquestive's Board of Directors, the members of which I hold in very high regard. I'd like to thank Keith, his team, and the Board for many exciting and satisfying years, and look forward to watching them accomplish even more great things for Aquestive in the months and years to come," stated Mr. Bratton.

    About Douglas K. Bratton

    Mr. Bratton has served as a member of the Company's Board of Directors since January 2004 and was the Chairman of the Board from January 2004 until August 2018. Mr. Bratton is the Founder, President and Chief Investment Officer of Crestline Investors, an institutional alternative investment management firm. He has been an investment professional specializing in alternative asset strategies since 1983 and has managed assets on behalf of the Bass family of Fort Worth, Texas since 1988.

    About Julie Krop, M.D.

    Dr. Krop is a seasoned biotech executive with more than two decades of experience successfully designing and executing clinical development programs from early stage development all the way through FDA approval. She has held senior leadership roles across clinical development, regulatory affairs, clinical operations, pharmacovigilance, medical affairs and program management during her career in the pharmaceutical and biotechnology industry. She currently serves as the Chief Medical Officer of Freeline Therapeutics (NASDAQ:FRLN). Prior to assuming her position with Freeline Therapeutics, Dr. Krop was the Chief Medical Officer and Executive Vice President, Development, at AMAG Pharmaceuticals (NASDAQ:AMAG) from 2015 to 2020. From 2012 to 2015, Dr. Krop served as the Vice President, Clinical Development for Vertex Pharmaceuticals (NASDAQ:VRTX). In addition, Dr. Krop was Vice President, Clinical Development and Regulatory Affairs for Stryker Biotech (NYSE:SYK) from 2006 to 2012. Dr. Krop received a B.A. from Brown University and her M.D. from Brown University School of Medicine. She completed her fellowship in the Department of Endocrinology at the Johns Hopkins University School of Medicine where she was also a Robert Wood Johnson Foundation Clinical Scholar.

    About Marco Taglietti, M.D.

    Dr. Taglietti has more than three decades of experience in the pharmaceutical and biotechnology industry. He currently serves as a Director and President and Chief Executive Officer of SCYNEXIS Inc. (NASDAQ:SCYX). Prior to joining SCYNEXIS, Dr. Taglietti held various executive positions with Forest Laboratories (now AbbVie (NYSE: ABBV)) from 2007 until 2014, including President, Forest Research Institute, Chief Medical Officer and Executive Corporate Vice President, Research & Development. Dr. Taglietti was also the Senior Vice President, Head of Global Research and Development for Stiefel Laboratories, Inc. (now a GlaxoSmithKline company) from 2004 until 2007 and served in a number of executive positions from 1992 to 2004 with Schering-Plough Research Institute, including Vice President, Clinical Research Anti-Infectives, CNS, Dermatology and Endocrinology. From 1987 until 1992, Dr. Taglietti served in a number of executive positions with Marion Merrell Dow Research Institute, including as the European Product Team Leader – Anti-Infectives. Dr. Taglietti previously served on the boards of directors of Delcath (NASDAQ:DCTH) from 2014 to 2020 and NephroGenex (NASDAQ:NRX) from 2014 to 2017. Dr. Taglietti also served as a director of Stiefel International, Ltd., a private company, from 2004 to 2007 and a director of TransCelerate BioPharma, a non-profit pharma coalition dedicated to streamlining and accelerating the research and development of innovative new therapies, from 2013 to 2014. Since 2011, Dr. Taglietti has served on the board of directors of BioNJ, a life sciences trade association in New Jersey. In addition, Dr. Taglietti served on the board of directors of HINJ, Health Institute of New Jersey, a trade association for the leading research-based biopharmaceutical and medical technology companies in New Jersey, from 2011 to 2014, and is currently on the boards of directors of Orchestra of St. Luke, a New York City based orchestra, and American Foundation for Suicide Prevention, the largest non-profit organization dedicated to saving lives and bringing hope to those affected by suicide. Dr. Taglietti received his Degree in Medicine from the University of Pavia, Italy.

    About Aquestive Therapeutics

    Aquestive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. The Company has commercialized one internally-developed proprietary product to date, Sympazan® (clobazam) oral film, has a commercial proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, and other unmet needs, and is developing orally administered complex molecules to provide alternatives to invasively administered standard of care therapies. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven capabilities for drug development and commercialization.

    Forward-Looking Statements

    Certain statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement of Libervant and other product candidates through the regulatory and development pipeline; and business strategies, market opportunities, and other statements that are not historical facts. These forward-looking statements are subject to the uncertain impact of the COVID-19 global pandemic on our business including with respect to our clinical trials including site initiation, patient enrollment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approvals of our product candidates; pharmaceutical ingredient and other raw materials supply chain, manufacture, and distribution; sale of and demand for our products; our liquidity and availability of capital resources; customer demand for our products and services; customers' ability to pay for goods and services; and ongoing availability of an appropriate labor force and skilled professionals. Given these uncertainties, the Company is unable to provide assurance that operations can be maintained as planned prior to the COVID-19 pandemic.

    These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for AQST-108 and our other drug candidates; risk of delays in FDA approval of our drug candidate Libervant and AQST-108 and our other drug candidates or failure to receive approval; ability to address the concerns identified in the FDA's Complete Response Letter dated September 25, 2020 regarding the New Drug Application for Libervant; risk of our ability to demonstrate to the FDA "clinical superiority" within the meaning of the FDA regulations of Libervant relative to FDA-approved diazepam rectal gel and nasal spray products including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved products as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity granted by the FDA for the approved nasal spray product of a competitor in the U.S. and there can be no assurance that we will be successful; risk that a competitor obtains FDA orphan drug exclusivity for a product with the same active moiety as any of our other drug products for which we are seeking FDA approval and that such earlier approved competitor orphan drug blocks such other product candidates in the U.S. for seven years for the same indication; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risks and uncertainties concerning the royalty and other revenue stream of the KYNMOBI™ monetization transaction, achievement of royalty targets worldwide or in any jurisdiction and certain other commercial targets required for contingent payments under the monetization transaction, and of sufficiency of net proceeds of the monetization transaction after satisfaction of and compliance with 12.5% Senior Notes obligations, as applicable, and for funding the Company's operations; risk of development of our sales and marketing capabilities; risk of legal costs associated with and the outcome of our patent litigation challenging third party at risk generic sale of our proprietary products; risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer term cash requirements and other cash needs, at the times and in the amounts needed; risk of failure to satisfy all financial and other debt covenants and of any default; our and our competitors' orphan drug approval and resulting drug exclusivity for our products or products of our competitors; short-term and long-term liquidity and cash requirements, cash funding and cash burn; risk related to government claims against Indivior for which we license, manufacture and sell Suboxone® and which accounts for the substantial part of our current operating revenues; risk associated with Indivior's cessation of production of its authorized generic buprenorphine naloxone film product, including the impact from loss of orders for the authorized generic product and risk of eroding market share for Suboxone and risk of sunsetting product; risks related to the outsourcing of certain marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance of our product and product candidates; the success of any competing products, including generics; risk of the size and growth of our product markets; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company's products; risk of unexpected patent developments; the impact of existing and future legislation and regulatory provisions on product exclusivity; legislation or regulatory actions affecting pharmaceutical product pricing, reimbursement or access; claims and risks that may arise regarding the safety or efficacy of the Company's products and product candidates; risk of loss of significant customers; risks related to legal proceedings, including patent infringement, investigative and antitrust litigation matters; changes in government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the "Risk Factors" section and in other sections included in our Annual Report on Form 10 K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K filed with the Securities Exchange Commission (SEC). Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.

    PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

    Investor inquiries:

    Westwicke, an ICR Company

    Stephanie Carrington



    646-277-1282

     



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  2. WALTHAM, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. has submitted its response to the FDA's Notice of Opportunity for a Hearing ("NOOH") regarding the Agency's proposal to withdraw approval for Makena—also referred to as 17-OHPC—the only FDA-approved treatment, along with five generic versions, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

    The submission of supporting documentation follows upon AMAG's October 14, 2020 request for a hearing and provides detail on the company's position in requesting a hearing, recognizing clinicians' decade-long use of this treatment and the public health implications of withdrawing approval. The response sets…

    WALTHAM, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. has submitted its response to the FDA's Notice of Opportunity for a Hearing ("NOOH") regarding the Agency's proposal to withdraw approval for Makena—also referred to as 17-OHPC—the only FDA-approved treatment, along with five generic versions, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

    The submission of supporting documentation follows upon AMAG's October 14, 2020 request for a hearing and provides detail on the company's position in requesting a hearing, recognizing clinicians' decade-long use of this treatment and the public health implications of withdrawing approval. The response sets out data, analyses, and information demonstrating why Makena should remain available as the only FDA-approved option for women in the U.S. who are at risk for preterm birth, including clinical study results that highlights the evidence of effectiveness of Makena among Black and other minority women.

    AMAG—and its new owner, Covis Pharma Group, a leading pharmaceutical company that has a track record of working collaboratively with FDA and is focused on providing therapeutic solutions for patients with life-threatening conditions and chronic illnesses—stand ready to discuss data-driven next steps to maintain Makena as an option for physicians and patients, including developing a new randomized, controlled trial and further evaluating real-world data.

    "We seek a hearing to ensure that higher risk women and their doctors retain access to the only safe and effective, FDA-approved treatment for preterm birth and remain committed to the science and clinical experience supporting the value of Makena for appropriate U.S. patients," said Covis CEO Michael Porter. "We stand ready to work collaboratively with the Agency to address methods of more fully understanding and maintaining this important treatment option for this high-risk underrepresented, principally minority patient population. Preterm birth is an increasing health issue in the U.S., with preterm birth rates significantly higher than in other developed countries. We believe that a thorough review of the benefits of Makena, particularly among at-risk, disadvantaged communities, is required."

    Nearly a year after the divided Advisory Committee meeting and without an opportunity to discuss options for further data generation, FDA sent a NOOH to AMAG and generic manufacturers of 17-OHPC. At the Advisory Committee meeting, experts agreed that additional data would be useful in clarifying benefit or defining the population in whom the drug may provide the most benefit. AMAG agrees that additional data would be helpful and had hoped to discuss several possible avenues with FDA.

    AMAG, and its new owner Covis, remain committed to conducting a further study of 17-OHPC. As described in the submission response, possible additional studies include: (1) a retrospective study using secondary real-world data sources, including electronic health record databases and claims databases; and (2) a prospective, primary data collection study with selected hospitals and healthcare networks, such as the Maternal-Fetal Medicine Units Network as well as non-academic sites. AMAG is also open to discussing another randomized clinical trial, better focused on the most at-risk, principally minority patient populations.

    A summary of key arguments that warrant discussion at a public forum can be found in the full copy of the submission available here. While the FDA reviews the submission of supporting documentation, Makena remains approved and available and the product label remains unchanged.

    About AMAG

    AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    About Covis

    Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.

    Media Contact

    Jill Courtney Kornmayer

     



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  3. LUXEMBOURG and ZUG, Switzerland, Nov. 16, 2020 /PRNewswire/ -- Covis Group S.à r.l. ("Covis") today announced the completion of its acquisition of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) through the successful tender offer for all of the outstanding shares of common stock of AMAG at $13.75 per share in cash and subsequent merger. The combined organization will operate as part of the Covis Pharma Group and will be led by Covis CEO Michael Porter.

    The addition of AMAG's category leading treatments and development-stage assets in women's health and hematology/oncology supports the execution of Covis' strategic vision to enhance the company's ability to impact the lives of patients by expanding its portfolio of 'best in class' products in attractive…

    LUXEMBOURG and ZUG, Switzerland, Nov. 16, 2020 /PRNewswire/ -- Covis Group S.à r.l. ("Covis") today announced the completion of its acquisition of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) through the successful tender offer for all of the outstanding shares of common stock of AMAG at $13.75 per share in cash and subsequent merger. The combined organization will operate as part of the Covis Pharma Group and will be led by Covis CEO Michael Porter.

    The addition of AMAG's category leading treatments and development-stage assets in women's health and hematology/oncology supports the execution of Covis' strategic vision to enhance the company's ability to impact the lives of patients by expanding its portfolio of 'best in class' products in attractive new therapeutic areas. In addition, Covis will be positioned to further support patients, building on its track record of efficient and effective management of therapeutic solutions.

    "The acquisition of AMAG represents a key milestone in Covis' efforts to fulfill our strategic vision to become a leading global specialty pharma company for life threatening and chronic illnesses for both commercial and development stage assets," said Michael Porter, CEO of Covis. "AMAG's expertise and key products—Feraheme®, Makena® and Ciraparantag—add tremendous value to Covis as we execute our mandate of expanding patient access to much needed therapies. We will continue to put patients' interests first and look forward to collaborating with the FDA to ensure that Makena continues to be available as an option for appropriate patients. More than ever, we are positioned to continue growth of our therapeutic portfolio globally and look forward to further enhancing our capabilities and offerings.  We're excited to work with our designated transition teams to execute on our integration plans and move forward as a stronger, unified organization."

    The tender offer expired at 12:00 a.m., Eastern Time, on November 12, 2020 (one minute after 11:59 p.m., Eastern Time, on November 12, 2020).  The condition to the tender offer that a majority of the outstanding shares of AMAG's common stock be validly tendered and not withdrawn was satisfied and, accordingly, all such validly tendered shares were accepted for payment.  Following the consummation of the tender offer, Covis Mergerco Inc. merged with and into AMAG pursuant to Section 251(h) of the General Corporation Law of the State of Delaware. As a result of the merger, each share of AMAG that was not validly tendered in the tender offer (other than shares held by any stockholder of AMAG who properly demanded appraisal of such shares under the applicable provisions of Delaware law) was cancelled and converted into the right to receive $13.75 per share in cash, and AMAG became an indirect wholly owned subsidiary of Covis. Shares of AMAG will cease to be traded on NASDAQ.

    Goldman Sachs & Co. LLC acted as exclusive financial advisor, and Goodwin Procter LLP acted as legal advisor to AMAG.  Paul, Weiss, Rifkind, Wharton and Garrison LLP acted as legal advisor to Covis. Financing for this transaction has been provided by Capital One, N.A. and investment funds and accounts managed by HPS Investment Partners, LLC.

    About Covis

    Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses.  Additional information is available at www.covispharma.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This communication contains forward-looking statements. Forward-looking statements relate to future events or Covis' future financial performance. Covis generally identifies forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar words. These statements are only predictions. Covis has based these forward-looking statements largely on its then-current expectations and projections about future events and financial trends as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Covis' control. Covis' actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: risks associated with the combined organization following completion of the merger transaction including difficulties in executing Covis' strategic vision, continuing to grow Covis' therapeutic portfolio and enhancing Covis' capabilities and offerings; the outcome of any legal proceedings that may be instituted against the parties and others related to the merger transaction; the inability of Covis' to impact the lives of patients by expanding its portfolio of 'best in class' products in attractive new therapeutic areas; Covis not being positioned to further support patients, and failing to efficiently and effectively manage therapeutic solutions; Covis not being able to fulfill its strategic vision of becoming a leading specialty pharma company globally for life threatening and chronic illnesses for both commercial and development stage assets, which could have a material adverse impact on Covis' business, financial results and operations; Covis failing to collaborate with the FDA to ensure that Makena continues to be available as an option for appropriate patients; risks associated with Makena's withdrawal, including the impacts on Covis' financial results; Covis failing to grow its therapeutic portfolio globally and enhancing its capabilities and offerings; Covis not being able to execute on its integration plans, resulting in a failure to achieve synergies or a more unified, stronger organization; and unanticipated difficulties or expenditures relating to the merger transaction, the response of business partners and competitors to the completion of the merger transaction, and/or potential difficulties in employee retention as a result of the completion of the merger transaction. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Covis cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Covis undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.

    Contact

    Arik Ben-Zvi

    Breakwater Strategy

    (202) 270-1848

    Cision View original content:http://www.prnewswire.com/news-releases/covis-group-completes-acquisition-of-amag-pharmaceuticals-301173667.html

    SOURCE Covis Pharma

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  4. NEW YORK, Nov. 5, 2020 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P  MidCap 400 and SmallCap 600 effective prior to the opening of trading on Friday, November 13:

    • First Bancorp (NASD:FBNC) will replace AMAG Pharmaceuticals Inc. (NASD:AMAG) in the S&P SmallCap 600. Covis Group is acquiring AMAG Pharmaceuticals in a deal expected to be completed soon pending final conditions.
    • MGIC Investment Corp. (NYSE:MTG) will replace The Geo Group Inc. (NYSE:GEO) in the S&P MidCap 400, and The Geo Group will replace Gulfport Energy Corp. (NASD:GPOR) in the S&P SmallCap 600. Halozyme Therapeutics Inc.(NASD:HALO) will replace Mednax Inc. (NYSE:MD) in the S&P MidCap 400, and Mednax will replace Washington Prime Group Inc. (NYSE…

    NEW YORK, Nov. 5, 2020 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P  MidCap 400 and SmallCap 600 effective prior to the opening of trading on Friday, November 13:

    • First Bancorp (NASD:FBNC) will replace AMAG Pharmaceuticals Inc. (NASD:AMAG) in the S&P SmallCap 600. Covis Group is acquiring AMAG Pharmaceuticals in a deal expected to be completed soon pending final conditions.
    • MGIC Investment Corp. (NYSE:MTG) will replace The Geo Group Inc. (NYSE:GEO) in the S&P MidCap 400, and The Geo Group will replace Gulfport Energy Corp. (NASD:GPOR) in the S&P SmallCap 600. Halozyme Therapeutics Inc.(NASD:HALO) will replace Mednax Inc. (NYSE:MD) in the S&P MidCap 400, and Mednax will replace Washington Prime Group Inc. (NYSE:WPG) in the S&P SmallCap 600. The GEO Group and Mednax are more representative of the small-cap market space. Gulfport Energy and Washington Prime Group are no longer representative of the small-cap market space.

    Following is a summary of the changes that will take place prior to the open of trading on the effective date:

    Effective Date

    Index Name      

    Action

    Company Name

    Ticker

    GICS Sector

    November 13, 2020

    S&P MidCap 400

    Addition

    MGIC Investment

    MTG

    Financials



    S&P MidCap 400

    Addition

    Halozyme Therapeutics

    HALO

    Health Care



    S&P MidCap 400

    Deletion

    Geo Group

    GEO

    Real Estate



    S&P MidCap 400

    Deletion

    Mednax

    MD

    Health Care



    S&P SmallCap 600

    Addition

    First Bancorp

    FBNC

    Financials



    S&P SmallCap 600

    Addition

    Geo Group

    GEO

    Real Estate



    S&P SmallCap 600

    Addition

    Mednax

    MD

    Health Care



    S&P SmallCap 600

    Deletion

    AMAG Pharmaceuticals

    AMAG

    Health Care



    S&P SmallCap 600

    Deletion

    Gulfport Energy

    GPOR

    Energy



    S&P SmallCap 600

    Deletion

    Washington Prime Group

    WPG

    Real Estate

    For more information about S&P Dow Jones Indices, please visit www.spdji.com

    ABOUT S&P DOW JONES INDICES

    S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has been innovating and developing indices across the spectrum of asset classes helping to define the way investors measure and trade the markets.

    S&P Dow Jones Indices is a division of S&P Global (NYSE:SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spdji.com.

    FOR MORE INFORMATION:

    S&P Dow Jones Indices

    Media Inquiries

    Cision View original content:http://www.prnewswire.com/news-releases/mgic-investment--halozyme-therapeutics-set-to-join-sp-midcap-400-first-bancorp-the-geo-group--mednax-to-join-sp-smallcap-600-301167618.html

    SOURCE S&P Dow Jones Indices

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  5. NEW YORK, Oct. 31, 2020 /PRNewswire/ -- Halper Sadeh LLP, a global investor rights law firm, announces it is investigating:

    Virtusa Corporation (NASDAQ:VRTU) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to funds affiliated with Baring Private Equity Asia for $51.35 per share. If you are a Virtusa shareholder, click on this link to learn more about your rights and options:  https://halpersadeh.com/actions/virtusa-corporation-vrtu-stock-merger-baring-asia/.

    AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Covis Group S.à r.l. for $13.75 per share in cash. If you are an AMAG shareholder, click on this link to learn more about your rights and options:  https://halpersadeh.com/actions/amag-pharmaceuticals-inc-stock-merger-covis/.

    Eaton Vance Corp. (NYSE:EV) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Morgan Stanley. If you are an Eaton Vance shareholder, click on this link to learn more about your rights and options:  https://halpersadeh.com/actions/eaton-vance-corp-ev-stock-merger-morgan-stanley/.

    Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to a consortium that includes members of Cellular Biomedicine management and several entities. If you are a Cellular Biomedicine shareholder, click on this link to learn more about your rights and options: https://halpersadeh.com/actions/cellular-biomedicine-group-inc-cbmg-stock-merger/.

    Halper Sadeh LLP may seek increased consideration, additional disclosures and information concerning the proposed transaction, or other relief and benefits on behalf of shareholders.

    Shareholders are encouraged to contact the firm free of charge to discuss their legal rights and options. Please call Daniel Sadeh or Zachary Halper at (212) 763-0060 or email  or .

    Halper Sadeh LLP represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.

    Attorney Advertising. Prior results do not guarantee a similar outcome.

    Contact Information:

    Halper Sadeh LLP

    Daniel Sadeh, Esq.

    Zachary Halper, Esq.

    (212) 763-0060



      

    https://www.halpersadeh.com

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    SOURCE Halper Sadeh LLP

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  6. NEW YORK, Oct. 21, 2020 /PRNewswire/ -- Moore Kuehn, PLLC, a law firm focusing in securities litigation located on Wall Street in downtown New York City, is investigating potential claims concerning whether the following proposed mergers are fair to shareholders.  Moore Kuehn may seek increased consideration, additional disclosures, or other relief on behalf of the shareholders of these companies:

    • NTN Buzztime, Inc. (NYSE:NTN)

    A registration statement was recently filed with the SEC regarding Brooklyn ImmunoTherapeutics' acquisition of NTN.  Upon completion of the merger, shareholders of NTN will own between approximately 5.92% and 3.26% of the combined company.  The investigation concerns whether NTN's board oversaw an unfair process and agreed to an inadequate deal price.

    • Concho Resources Inc. (NYSE: CXO)

    Concho Resource has agreed to be acquired by ConocoPhillips.  Under the proposed transaction, shareholders of Concho will receive 1.46 shares of ConocoPhillips per share.

    • AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG)

    A solicitation statement was recently filed with the SEC regarding Covis Group's acquisition of AMAG, which may omit material information used to evaluate the merger.  Under the proposed transaction, shareholders of AMAG will receive $13.75 per share.

    • Front Yard Residential Corporation (NYSE: RESI)

    Front Yard Residential has agreed to be acquired by Pretium and a group of its investors and funds.  Under the proposed transaction, shareholders of Front Yard will receive $13.50 per share.

    Moore Kuehn is investigating whether the Boards of the above companies 1) acted to maximize shareholder value, 2) failed to disclose material information, and 3) conducted a fair process. 

    Moore Kuehn encourages shareholders who would like to discuss their rights to contact Justin Kuehn, Esq. by email at or telephone at (212) 709-8245.  The consultation and case are free with no obligation to you.  Moore Kuehn pays all case costs and does not charge its investor clients. Shareholders should contact the firm immediately as there may be limited time to enforce your rights.  

    Moore Kuehn is a 5-star Google rated New York City law firm with attorneys representing investors and consumers in litigation involving securities laws, fraud, breaches of fiduciary duties, and other claims.  For additional information about Moore Kuehn, please visit http://www.moorekuehn.com/practice/new-york-securities-litigation/.

    Attorney advertising. Prior results do not guarantee similar outcomes.

    Contacts:

    Moore Kuehn, PLLC

    Justin Kuehn, Esq.

    30 Wall Street, 8th Floor

    New York, New York 10005



    (212) 709-8245

     

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  7. NEW YORK, Oct. 21, 2020 /PRNewswire/ -- Halper Sadeh LLP, a global investor rights law firm, is investigating:

    AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Covis Group S.à r.l. for $13.75 per share in cash. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/amag-pharmaceuticals-inc-stock-merger-covis/.

    Virtusa Corporation (NASDAQ:VRTU) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to funds affiliated with Baring Private Equity Asia for $51.35 per share. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/virtusa-corporation-vrtu-stock-merger-baring-asia/.

    Parsley Energy, Inc. (NYSE:PE) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Pioneer Natural Resources Company for 0.1252 shares of Pioneer common stock for each share of Parsley common stock. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/parsley-energy-inc-pe-stock-merger-pioneer/.

    Cleveland BioLabs, Inc. (NASDAQ:CBLI) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its merger with Cytocom, Inc. Under the merger, Cleveland BioLabs stockholders are expected to own approximately 39% of the combined company. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/cleveland-biolabs-inc-cbli-stock-merger/.

    Halper Sadeh LLP may seek increased consideration, additional disclosures and information concerning the proposed transaction, or other relief and benefits on behalf of shareholders.

    Shareholders are encouraged to contact the firm free of charge to discuss their legal rights and options. Please call Daniel Sadeh or Zachary Halper at (212) 763-0060 or email  or .

    Halper Sadeh LLP represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.

    Attorney Advertising. Prior results do not guarantee a similar outcome.

    Contact Information:

    Halper Sadeh LLP

    Daniel Sadeh, Esq.

    Zachary Halper, Esq.

    (212) 763-0060

     

      

    https://www.halpersadeh.com

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  8. LUXEMBOURG and ZUG, Switzerland, Oct. 15, 2020 /PRNewswire/ -- Covis Group S.à r.l. ("Covis") announced the commencement of a cash tender offer to purchase all of the outstanding shares of common stock of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) ("AMAG"). The tender offer is being made pursuant to the merger agreement (the "Merger Agreement") announced by Covis and AMAG on October 1, 2020 under which Covis has agreed to acquire AMAG for $13.75 per share. The transaction has a total enterprise value of approximately $647 million, including net debt.

    The $13.75 per share all-cash tender offer represents a premium of approximately 46% over AMAG's closing stock price on September 30, 2020, the last full trading day prior to the announcement.

    A tender…

    LUXEMBOURG and ZUG, Switzerland, Oct. 15, 2020 /PRNewswire/ -- Covis Group S.à r.l. ("Covis") announced the commencement of a cash tender offer to purchase all of the outstanding shares of common stock of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) ("AMAG"). The tender offer is being made pursuant to the merger agreement (the "Merger Agreement") announced by Covis and AMAG on October 1, 2020 under which Covis has agreed to acquire AMAG for $13.75 per share. The transaction has a total enterprise value of approximately $647 million, including net debt.

    The $13.75 per share all-cash tender offer represents a premium of approximately 46% over AMAG's closing stock price on September 30, 2020, the last full trading day prior to the announcement.

    A tender offer statement on Schedule TO that includes the Offer to Purchase and related Letter of Transmittal that set forth the terms and conditions of the tender offer will be filed today by Covis and its subsidiary that will be making the offer. Additionally, AMAG will file with the U.S. Securities and Exchange Commission (the "SEC") a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of AMAG's board of directors that AMAG stockholders tender their shares in the tender offer.

    The tender offer will expire at 12:00 midnight (New York City time) on November 12, 2020 (one minute after 11:59 P.M. New York City time on November 12, 2020), unless the offer period is extended in accordance with the Merger Agreement and the applicable rules and regulations of the SEC. The completion of the tender offer will be conditioned on AMAG's stockholders tendering at least a majority of AMAG's outstanding shares and other customary closing conditions.

    If, as a result of the tender offer, the stockholders tender at least one share more than 50% of the then outstanding shares of AMAG's common stock, the subsidiary of Covis will, subject to the satisfaction or waiver of the remaining conditions set forth in the Merger Agreement, merge with and into AMAG, with AMAG surviving as an indirect wholly owned subsidiary of Covis, under Section 251(h) of the Delaware General Corporation Law, without prior notice to, or any action by, any other stockholder of AMAG, as soon as practicable following the consummation of the tender offer.

    Okapi Partners LLC is acting as information agent for Covis in the tender offer. American Stock Transfer & Trust Company LLC is acting as depositary and paying agent in the tender offer. Requests for documents and questions regarding the tender offer may be directed to Okapi Partners LLC by telephone at (844) 343-2621 or banks and brokers may call (212) 297-0720, or by email at .

    About Covis

    Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.

    Additional Information and Where to Find It

    This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Covis and its acquisition subsidiary is filing today with the SEC. Covis and its acquisition subsidiary will today cause to be filed a tender offer statement on Schedule TO with the SEC, and AMAG will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the tender offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT CONTAINS IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BY THE STOCKHOLDERS OF AMAG BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Both the tender offer statement and the solicitation/recommendation statement will be mailed to AMAG's stockholders free of charge. A free copy of the tender offer statement and the solicitation/recommendation statement will also be made available to all stockholders of AMAG by accessing www.amagpharma.com or by contacting AMAG's Investor Relations contact at . In addition, the tender offer statement and the solicitation/recommendation statement (and all other documents filed with the SEC) will be available at no charge on the SEC's website: www.sec.gov.

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    SOURCE Covis Pharma

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  9. WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration's (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meis et al. A second, FDA-required trial (PROLONG) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety…

    WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration's (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meis et al. A second, FDA-required trial (PROLONG) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed.

    Today's hearing request will be followed by a submission of supporting documentation to the FDA. That submission will provide further detail on the company's reasoning for a hearing, recognizing clinicians' decade-long use of this treatment and the public health implications of withdrawing its approval. At this time, it is important to note that Makena remains approved and available and the product label remains unchanged.

    "We believe it is in the best interest of these high-risk pregnant patients to allow their obstetrical provider to determine whether to use Makena, following the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) guidelines, as well as their own long-standing clinical experience. The continued widening of maternal and infant health disparities among minority and disadvantaged communities, and the potential return to compounded versions of Makena are concerning," said AMAG CEO Scott Myers. "We remain committed to preserving access to the FDA-approved therapy, as there are no other evidence-based options for these vulnerable patients."

    AMAG submitted a proposal earlier this year to the FDA, requesting to meet and discuss two studies intended to define the patient population who would most benefit from therapy: a retrospective study using real world evidence, and a prospective, primary data collection study. FDA declined the request to meet, stating it was premature. AMAG announced in August that it was beginning the first part of the retrospective study.

    Covis Pharma has entered into a transaction to acquire AMAG, which is subject to customary closing conditions including the tender offering and is expected to close in November.

    Commenting on AMAG's hearing request, Covis Pharma CEO Michael Porter said, "We support the efforts by AMAG to preserve patient access to this important treatment option. AMAG and Covis believe in Makena's efficacy for those at risk for recurrent preterm birth, which are often vulnerable patient groups. We respectfully believe that further study is necessary before precipitously withdrawing the product from the market and are prepared to help formulate and implement appropriate study parameters for additional review of its efficacy."

    ACOG issued a statement in response to FDA's proposed withdrawal, noting that the need for an effective preterm birth treatment is great. As ACOG further recognized, Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition. ACOG states that their treatment recommendations remain unchanged at this time.

    ABOUT AMAG

    AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    Forward Looking Statements

    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, statements regarding plans to submit, and expectations for, supporting documentation to the FDA; beliefs that it is in the best interest of patients to allow access to Makena; beliefs about maternal and infant health disparities among minority communities and the return to compounded versions of Makena, and that there are no other evidence-based options; beliefs, including beliefs attributed to other groups, in Makena's efficacy for those at risk, including that further study should be undertaken into the efficacy of Makena before taking action to withdraw the product from the market and the ability of AMAG's efforts to preserve patient access to Makena; expectations for working towards formulating and implementing appropriate study parameters to be undertaken to confirm Makena's efficacy after the tender offer and merger transaction between Covis and AMAG closes, and expectations for the recently announced tender offer and merger transaction 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 secure 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 (or before or during the pendency of the hearing and deliberation), the pursuit and planning of which could be costly and distracting to management, the risks related to the pending tender offer and merger transaction (including as described in our Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) on October 1, 2020), and those other risks identified in AMAG's filings with 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.

    AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc.

    AMAG CONTACT:

    Investors & Media:

    Rushmie Nofsinger

    (617) 498-2806

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  10. NEW YORK, Oct. 5, 2020 /PRNewswire/ -- Halper Sadeh LLP, a global investor rights law firm, is investigating:

    AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Covis Group S.à r.l. for $13.75 per share in cash. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/amag-pharmaceuticals-inc-stock-merger-covis/.

    Spring Bank Pharmaceuticals, Inc. (NASDAQ:SBPH) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its proposed merger with F-star Therapeutics, Limited. Under the terms of the share exchange agreement, Spring Bank will acquire all of the outstanding share capital of F-star in exchange for the issuance of newly issued shares of Spring Bank common stock. Spring Bank shareholders will own approximately 38.8% of the combined company. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/spring-bank-pharmaceuticals-inc-sbph-stock-merger-fstar/.

    Varian Medical Systems, Inc. (NYSE:VAR) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Siemens Healthineers AG for $177.50 per share. Visit our website to learn more and participate in an action: https://halpersadeh.com/actions/varian-medical-systems-inc-var-stock-merger-siemens.

    SINA Corporation (NASDAQ:SINA) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to New Wave Holdings Limited and New Wave Mergersub Limited for $43.30 in cash per share. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/sina-corporation-stock-merger-new-wave/.

    Garrison Capital Inc. (NASDAQ:GARS) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Portman Ridge Finance Corporation. Following the proposed transaction, Garrison Capital shareholders are expected to own approximately 41.6% of the combined company. Visit our website to learn more about your legal rights and options: https://halpersadeh.com/actions/garrison-capital-inc-gars-portman-ridge-stock-merger/.

    Halper Sadeh LLP may seek increased consideration, additional disclosures and information concerning the proposed transaction, or other relief and benefits on behalf of shareholders.

    Shareholders are encouraged to contact the firm free of charge to discuss their legal rights and options. Please call Daniel Sadeh or Zachary Halper at (212) 763-0060 or email  or .

    Halper Sadeh LLP represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.

    Attorney Advertising. Prior results do not guarantee a similar outcome.

    Contact Information:

    Halper Sadeh LLP

    Daniel Sadeh, Esq.

    Zachary Halper, Esq.

    (212) 763-0060



      

    https://www.halpersadeh.com

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    • The product remains on the market
    • AMAG has 15 days to respond to the FDA
    • AMAG continues to expect its recently announced tender offer and merger to close in November 2020

    WALTHAM, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth. The FDA in its letter also notified AMAG that the company has the opportunity to request a hearing on the withdrawal.

    AMAG is evaluating its full range of potential options. The company has…

    • The product remains on the market

    • AMAG has 15 days to respond to the FDA
    • AMAG continues to expect its recently announced tender offer and merger to close in November 2020

    WALTHAM, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth. The FDA in its letter also notified AMAG that the company has the opportunity to request a hearing on the withdrawal.

    AMAG is evaluating its full range of potential options. The company has 15 days to respond to the FDA indicating whether AMAG would like to proceed with a hearing. If AMAG does request a hearing, the FDA Commissioner would decide whether to grant AMAG's request and, if granted, would conduct a hearing and decide whether to withdraw approval following the hearing. This process can take months and during this time Makena and the approved generics of Makena will remain on the market, according to the FDA.

    "We disagree with the FDA's proposal to withdraw Makena without having the opportunity to meet with them to discuss the generation of additional effectiveness data while preserving access for patients to the only FDA approved treatment option for indicated women," said AMAG CEO Scott Myers. "We are reviewing our options, including the opportunity to request an oral hearing, and will respond to the agency within the allotted time. We continue to expect the transaction with Covis to close in November 2020."

    At this time, it is important to note that Makena's approval and product label remain unchanged. The product continues to remain available to patients and prescribers. You may learn more about current medical society guidelines by visiting the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine.

    "I am concerned that withdrawal of Makena, as well as the generic equivalents, would leave vulnerable women with high risk pregnancies without access to a safe medication that physicians have relied upon for years, and has previously been shown to be highly effective when studied by the NICHD in a U.S. only population," Sean Blackwell M.D., Chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at the McGovern Medical School – UTHealth at Houston. "The PROLONG trial did not re-affirm efficacy, in my opinion, because it did not include enough women at high enough preterm birth risk.  Given the results of the original NICHD trial, removing the ability for physicians and their patients to make a shared-decision on the benefits and risks of the only FDA-approved medication to prevent preterm birth is disappointing."

    AMAG believes the totality of clinical data on Makena supports its continued positive benefit-risk profile and remains fully committed to retaining patient access to approved therapy. Makena and the generic equivalents are the only FDA-approved treatments available for pregnant women at risk for recurrent preterm birth.

    Preterm birth is the leading cause of infant morbidity and mortality in the U.S,i and a history of spontaneous preterm birth is a substantial risk factor for recurrent preterm birth.ii Women, particularly those of color, are profoundly impacted by preterm birth, which is associated with the potential for babies born early to experience lifelong complications.iii There is also increasing recognition that health care outcomes, such as preterm birth, are impacted by social determinants of health.iv

    ABOUT AMAG

    AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    Forward Looking Statements

    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, our plans following receipt of the Notice, including the possibility of requesting a hearing and the timeline for the process and that Makena will remain on the market, beliefs about the impact of withdrawal on the patient population and data supporting the efficacy of Makena, including our belief that the totality of clinical data on Makena supports its continued positive benefit-risk profile, and expectations for the recently announced tender offer and merger transaction 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 (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.

    AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc.

    AMAG CONTACT:

    Investors & Media:

    Rushmie Nofsinger

    (781) 530-6838

    i March of Dimes. Long-term Health Effects of Premature Birth. https://www.marchofdimes.org/complications/long-term-health-effects-of-premature-birth.aspx. Accessed October 22, 2019.

    ii March of Dimes. Preterm Labor and Premature Birth: Are You at Risk? https://www.marchofdimes.org/complications/preterm-labor-and-premature-birth-are-you-at-risk.aspx. Accessed October 22, 2019.

    iii National Center for Chronic Disease Prevention and Health Promotion, Division of Reproductive Health. Preterm Birth. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm. Accessed October 22, 2019.

    iv Importance of social determinants of health and cultural awareness in the delivery of reproductive health care. ACOG Committee Opinion No. 729. American College of Obstetricians and Gynecologists. Obstet Gynecol 2018;131:e43–8

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  11. Addition of AMAG's category leading treatments positions Covis to become a global market leader of therapeutic solutions for life-threatening conditions and chronic illnesses

    Covis will commence a tender offer to acquire all the outstanding shares of AMAG for a purchase price of $13.75 per share in cash, or approximately $647 million, including debt obligations expected to be assumed or repaid net of cash

    Transaction expected to close in November 2020 post tender offer

    LUXEMBOURG, ZUG, Switzerland and WALTHAM, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Covis Group S.à r.l. ("Covis") and AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that they have entered into a definitive agreement under which Covis will acquire AMAG for $13.75…

    Addition of AMAG's category leading treatments positions Covis to become a global market leader of therapeutic solutions for life-threatening conditions and chronic illnesses

    Covis will commence a tender offer to acquire all the outstanding shares of AMAG for a purchase price of $13.75 per share in cash, or approximately $647 million, including debt obligations expected to be assumed or repaid net of cash

    Transaction expected to close in November 2020 post tender offer

    LUXEMBOURG, ZUG, Switzerland and WALTHAM, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Covis Group S.à r.l. ("Covis") and AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that they have entered into a definitive agreement under which Covis will acquire AMAG for $13.75 per share in cash, or approximately $498 million on a fully diluted basis and approximately $647 million on an enterprise basis, including debt obligations expected to be assumed or repaid net of cash. The offer represents a premium of approximately 46% to the closing price of AMAG's common stock on September 30, the last full trading day prior to the announcement.

    Commenting on the transaction, Covis CEO Michael Porter said, "AMAG's category leading treatments are strong strategic complements to our existing therapeutic portfolio. Through this combination, we believe we will be able to unlock value for all of our stakeholders, employees and patients through the effective and efficient management of these products, coupled with our two companies' longstanding commitment to expanding patient access to therapy and putting patient interests first. At Covis, we never lose sight that our patients are our paramount concern. We look forward to engaging with the talented team at AMAG as we work together to plan the integration of our two organizations."

    AMAG CEO Scott Myers added, "In the beginning of 2020, AMAG announced that the company had undertaken a strategic review of our product portfolio and strategy, the guiding principles of which included driving near- and long-term profitability and enhancing shareholder value. This strategic review resulted in the company pursuing and accomplishing the divestiture of its women's health assets, and other efforts to streamline and strengthen the core business to position AMAG for the future. Following this initial transformation, our Board of Directors and management team, together with independent legal and financial advisors, thoroughly evaluated the transaction with Covis as well as other strategic options and concluded that it represents the most compelling opportunity for shareholders, providing them certain and immediate cash value. We believe Covis is the right partner for AMAG, especially in light of Covis' shared commitment to ensuring that our therapies will reach patients in need. We are confident the work we've done will continue to thrive under Covis' leadership."

    The completion of the tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG's common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the tender offer, an indirect, wholly owned subsidiary of Covis will merge with AMAG (the "merger") and the outstanding AMAG shares not tendered in the tender offer will be converted into the right to receive the same $13.75 per share in cash paid in the tender offer. The tender offer is expected to commence in October 2020. Covis plans to finance the transaction with cash on hand, and a combination of committed debt and equity financing. There is no financing condition to the obligations of Covis to consummate the transaction.

    As part of the transaction, Covis intends to enter into an amended and restated credit facility with its current lenders (the "Lenders"), pursuant to which the Lenders will provide up to a $460 million senior secured incremental term loan and a $55 million secured revolver (the "Covis Debt Financing"). The proceeds from the Covis Debt Financing, plus equity commitments from Covis' equity sponsor, will be used to pay the cash purchase price for the transaction and repay any of the existing AMAG debt that is not assumed. The Covis Debt Financing amount will be added to Covis' current $450 million term loan facility with the Lenders. As the merger will result in a change of control under the terms of AMAG's Indenture governing its 3.25% Convertible Senior Unsecured Notes Due 2022 (the "Convertible Notes"), the holders of the Convertible Notes will have the right to put at par the Convertible Notes held by them for a period of twenty business days following the closing of the merger.

    All Board members and executive officers of AMAG have agreed to tender their shares in favor of the transaction. The transaction, which has been unanimously approved by the Board of Directors of each company, is expected to close in November 2020, pending Hart-Scott-Rodino (HSR) approval and the conditions to the tender offer being satisfied.

    Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Goodwin Procter LLP is acting as legal advisor to AMAG. Paul, Weiss, Rifkind, Wharton and Garrison LLP is acting as legal advisor to Covis.

    About Covis

    Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.

    About AMAG

    AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    AMAG Pharmaceuticals®, the logo and designs are registered trademarks of AMAG Pharmaceuticals, Inc.

    Additional Information and Where to Find It

    The tender offer referred to in this document has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Covis and its acquisition subsidiary will file with the U.S. Securities and Exchange Commission (the "SEC") upon commencement of the tender offer. At the time the tender offer is commenced, Covis and its acquisition subsidiary will cause to be filed a tender offer statement on Schedule TO with the SEC, and AMAG will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the tender offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BY THE COMPANY'S STOCKHOLDERS BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Both the tender offer statement and the solicitation/recommendation statement will be mailed to AMAG's stockholders free of charge. A free copy of the tender offer statement and the solicitation/recommendation statement will also be made available to all stockholders of AMAG by accessing www.amagpharma.com or by contacting AMAG's Investor Relations contact at . In addition, the tender offer statement and the solicitation/recommendation statement (and all other documents filed with the SEC) will be available at no charge on the SEC's website: www.sec.gov, upon filing with the SEC.

    THE COMPANY'S STOCKHOLDERS ARE ADVISED TO READ THE SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.

    Cautionary Statement Regarding Forward-Looking Statements

    This communication contains forward-looking statements. Forward-looking statements relate to future events or AMAG's future financial performance. AMAG generally identifies forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar words. These statements are only predictions. AMAG has based these forward-looking statements largely on its then-current expectations and projections about future events and financial trends as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond AMAG's control. AMAG's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) risks associated with the timing of the closing of the proposed merger transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all, or that the financing for the transaction will be delayed or unavailable or that the closing of the proposed merger transaction will not occur; (ii) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (iii) unanticipated difficulties or expenditures relating to the proposed merger transaction, the response of business partners and competitors to the announcement of the proposed merger transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed merger transaction; and (iv) those risks detailed in AMAG's most recent Annual Report on Form 10-K and any subsequent reports filed with the SEC, including 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 any other documents that may be filed by AMAG from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. AMAG cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. AMAG undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.

    Contacts

    For Covis:

    Arik Ben-Zvi

    Breakwater Strategy

    (202) 270-1848

    For AMAG Pharmaceuticals:

    Investors

    Rushmie Nofsinger

    Vice President, Corporate Affairs & IR

    (617) 498-3332

    Media

    Chris Kittredge and Zachary Tramonti

    Sard Verbinnen & Co.

    (617) 546-4250

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  12. WALTHAM, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Scott Myers, Chief Executive Officer, and Brian Piekos, Chief Financial Officer, will participate in a fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 a.m. Eastern Time.

    A live audio webcast of the virtual event will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the company's website for 30 days.

    About AMAG

    AMAG is a commercial stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging…

    WALTHAM, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Scott Myers, Chief Executive Officer, and Brian Piekos, Chief Financial Officer, will participate in a fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 a.m. Eastern Time.

    A live audio webcast of the virtual event will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the company's website for 30 days.

    About AMAG

    AMAG is a commercial stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc.

    AMAG Pharmaceuticals Contact:

    Loraine Spreen

    617-866-0303

    Primary Logo

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  13. Financial guidance reissued to include EBITDA-positive projection for second-half 2020

    Strategic shift and momentum build through recent business development activities

    Brian Piekos promoted to Chief Financial Officer

    Conference call scheduled for 8:00 a.m. ET today

    WALTHAM, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the second quarter ended June 30, 2020. The company reported total revenues for the second quarter of 2020 of $52.8 million, including revenue of $29.6 million from Feraheme® (ferumoxytol injection) and revenue of $22.3 million from Makena® (hydroxyprogesterone caproate injection). The company also reported an operating loss…

    Financial guidance reissued to include EBITDA-positive projection for second-half 2020

    Strategic shift and momentum build through recent business development activities

    Brian Piekos promoted to Chief Financial Officer

    Conference call scheduled for 8:00 a.m. ET today

    WALTHAM, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the second quarter ended June 30, 2020. The company reported total revenues for the second quarter of 2020 of $52.8 million, including revenue of $29.6 million from Feraheme® (ferumoxytol injection) and revenue of $22.3 million from Makena® (hydroxyprogesterone caproate injection). The company also reported an operating loss of $7.0 million and an adjusted EBITDA loss of $1.7 million in the second quarter of 2020.1

    "Amidst the unprecedented uncertainty that COVID-19 placed on the healthcare system and our economy, AMAG's marketed therapeutics performed well in the second quarter due in part to our teams' ability to adapt in a rapidly-changing environment," said Scott Myers, AMAG's Chief Executive Officer.  "Over the past three months, we have advanced the company's strategic evolution by reaching important milestones that include a strategic, ex-US partnership with Norgine to further progress ciraparantag and strengthen our company's ability to invest in our pipeline.  We have also streamlined expenses by completing the divestment of Intrarosa® and Vyleesi® and making changes to our portfolio designed to further focus on programs with the highest potential to deliver innovative treatments for patients and unlock shareholder value."

    2020 FINANCIAL GUIDANCE

    ($M) 2020 Financial Guidance2
    Total revenue $225 - $255
    Operating loss $(40) - $(15)
    Non-GAAP Adjusted EBITDA3 $(5) - $20

    "Strong execution across our portfolio throughout the COVID-19 pandemic allows us to reissue financial guidance that reflects the relative stability of Makena over the quarter and the momentum that Feraheme began to build in June, which saw record highs in monthly share and ex-factory volume," said Brian Piekos, Chief Financial Officer.  "The guidance we are sharing today is designed to prioritize investments that will drive long-term growth while also putting us on track to return to positive adjusted EBITDA."

    PORTFOLIO UPDATES

    Ciraparantag (AMAG-977) – As previously announced, AMAG has completed an exclusive licensing agreement with Norgine, a leading European specialist pharmaceutical company, to develop and commercialize ciraparantag in Europe, Australia and New Zealand. Through this agreement, AMAG has received a total of $30 million in upfront consideration and could receive up to $260 million in future contingent development and commercial milestones4 together with escalating double-digit royalties. Additionally, Norgine has committed to contribute one-third of the costs of the Phase 3 clinical program, which would be conducted by AMAG to support regulatory approval of ciraparantag by the U.S. Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare Products Regulatory Agency. AMAG will continue to oversee the Phase 3 clinical program, while working closely with Norgine to develop and execute a global development strategy. The company believes this partnership will unlock value in ciraparantag and further strengthen AMAG's ability to continue investing in innovative therapies that address urgent unmet medical needs. 

    On July 12, AMAG presented a poster of data titled "Efficacy and Safety of Ciraparantag in Reversing Apixaban and Rivaroxaban in Healthy Adults" at the 2020 International Society on Thrombosis and Haemostatis (ISTH) virtual annual meeting.  This presentation shared data from two Phase 2 randomized, placebo-controlled, dose ranging studies which showed safety and efficacy of ciraparantag reversing the effects of apixaban and rivaroxaban in healthy adults age 50-75 years. Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time (WBCT).

    AMAG-423 – The AMAG-423 Phase 2b/3a study was designed to explore a potential treatment for severe preeclampsia, a serious medical condition that impacts about 50,000 women in the US each year.  As previously disclosed, the small population of eligible patients made the study difficult to enroll.  The COVID-19 pandemic has led to a global pause for various clinical research projects across therapeutic areas, including the AMAG-423 Phase 2b/3a study. In light of these extended and ongoing delays to study completion, AMAG decided to conduct an interim analysis with data from 55 subjects to validate original study assumptions that were based on the 51-subject proof-of-concept DEEP study completed in 2007. In order to continue keeping AMAG blinded to study treatment assignments, the independent Data and Safety Monitoring Board (DSMB) was tasked with conducting the interim analysis.

    Following this interim analysis, the DSMB provided a unanimous recommendation to stop the study, based upon the low likelihood that future enrollment would demonstrate a benefit of AMAG-423 in women with severe preeclampsia.  Importantly, there were no safety concerns raised during this study.  AMAG has accepted the DSMB's recommendation to stop the study and is currently focused on ensuring an appropriate closeout of the study in partnership with investigators and other relevant stakeholders.

    Divestiture of Intrarosa® and Vyleesi® – As previously announced, AMAG has completed the divestment of Intrarosa® and Vyleesi® which reduces operating expenses and allows the company to focus on optimizing its marketed assets and developing its innovative pipeline.

    CORPORATE UPDATES

    Leadership Appointments - The company has appointed Brian Piekos as its Chief Financial Officer, effective as of August 13, 2020.  Mr. Piekos has served as interim CFO since June 2020 after holding several senior management positions since joining AMAG in 2015. 

    SECOND QUARTER ENDED JUNE 30

    Revenue

    Second quarter revenue totaled $52.8 million, compared to $77.8 million for the same period in 2019.  This decrease was due to the negative impact of COVID-19 and the October 2019 unfavorable FDA Advisory Committee recommendation on Makena.

    • Feraheme achieved second quarter revenue of $29.6 million, a decrease of 30 percent over the same period last year. Feraheme's average quarterly market share was 17.3 percent in the second quarter of 2020, compared to 17.2 percent in the second quarter of 2019.
    • Makena second quarter revenue totaled $22.3 million, a decrease of 27 percent over the same period last year.  Makena's average quarterly market share was 66 percent in the second quarter of 2020, compared to 63 percent in the second quarter of 2019.
    ($M)Three Months Ended June 30,
      2020  2019
    Total revenues$52.8  $77.8
    Feraheme 29.6  42.1
    Makena 22.3  30.6
    Intrarosa 1.2  4.9
    Other (0.4) 0.2

    Operating Expenses

    Total costs and expenses decreased by $134.2 million to $59.8 million in the second quarter of 2020, as compared to the second quarter of 2019.

    • Cost of products sales in the second quarter of 2020 decreased by $6.1 million, as compared with the second quarter of last year.  Direct cost of product sales for the three months ended June 30, 2019 included a $4.8 million one-time inventory write-down related to the Makena IM product. Excluding this one-time inventory write-down, direct cost of product sales declined in the second quarter of 2020 due to reduced Feraheme and Makena sales and the divestment of Intrarosa.   
    • Research and development (R&D) expenses totaled $8.3 million, compared to $15.0 million in the first quarter of last year. This decrease was primarily related to lower costs for Vyleesi following FDA approval in 2019 and COVID-19 related delays in clinical trials.
    • Selling, general and administrative (SG&A) expenses decreased by approximately $37.8 million, or 49 percent, in the second quarter of 2020, compared to the same period in 2019. This decrease was primarily due to decreases in marketing spend related to women's health assets and reduced compensation-related costs as a result of the May 2020 restructuring.
    ($M)Three Months Ended June 30,
      2020  2019
    Amortization of intangible assets$9.0 $3.9
    Direct cost of product sales 9.2  20.3
    Total cost of product sales 18.2  24.2
    Research and development expenses 8.3  15.0
    Selling, general and administrative expenses 39.6  77.3
    Impairment of intangible assets   77.4
    Gain on sale of assets (14.4) 
    Restructuring expenses 8.2  
    Total costs and expenses$59.8 $194.0

    Operating Loss and Adjusted EBITDA

    • The company reported an operating loss of $7.0 million in the second quarter of 2020, compared to an operating loss of $116.2 million in the same period last year.
    • The company reported a loss in adjusted EBITDA  of $1.7 million in the second quarter of 2020, compared to a loss in adjusted EBITDA of $24.7 million in the same period last year.
    ($M)Three Months Ended June 30,
      2020  2019 
    Operating loss$(7.0)$(116.2)
    Non-GAAP adjusted EBITDA5$(1.7)$(24.7)

    The financial figures and statements referenced herein have been adjusted to correct immaterial errors in Makena revenue in the historical periods 2016 through the first quarter of 2020; in aggregate, Makena revenue is reduced by $6.3 million over the four-year period.  This error was identified by the company during the second quarter of 2020 and relates to the timely accrual of certain governmental rebates.  The company and our independent auditors are still reviewing the prior period financial statements and the potential impact on our internal controls over financial reporting for the periods.  Therefore, the financials set forth in this release are preliminary and may be updated in the company's quarterly report on Form 10Q for the quarter ended June 30, 2020.  As a result, investors are cautioned not to place undue reliance on these financial statements.

    CONFERENCE CALL AND WEBCAST ACCESS

    AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company's second quarter 2020 financial results and recent business updates.

    DIAL-IN NUMBERS

    U.S./Canada Dial-in Number: (877) 412-6083

    International Dial-in Number: (702) 495-1202

    Conference ID: 4548238

    Replay Dial-in Number: (855) 859-2056

    Replay International Dial-in Number: (404) 537-3406

    Conference ID: 4548238

    A telephone replay will be available from approximately 11:00 a.m. ET on August 6, 2020 through midnight on August 20, 2020

    The webcast with slides will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

    USE OF NON-GAAP FINANCIAL MEASURES

    AMAG has presented certain non-GAAP financial measures, including non-GAAP costs and expenses, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization) and non-GAAP diluted shares outstanding. These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG's GAAP financial statements, because it provides greater transparency regarding AMAG's operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG's operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

    _______________________________

    1 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release

    2 2020 Operating Loss financial guidance excludes the accounting impact of the following subsequent events announced in July: termination of the Vyleesi license agreement with Palatin and costs associated with discontinuing the AMAG-423 program.

    3 See reconciliations of 2020 GAAP to non-GAAP financial guidance at the conclusion of this press release.

    4 40.0 million of such milestones would be paid to the former equity holders of Perosphere Pharmaceuticals Inc. pursuant to the Agreement and Plan of Merger with Perosphere.

    5 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release.



    ABOUT AMAG

    AMAG is a commercial stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, statements regarding the performance of AMAG's marketed therapeutics, including about the stability of Makena and the momentum of Feraheme through the COVID-19 pandemic; beliefs about the team's adaptability, the benefits of and expectations for recent business milestones, AMAG's current pipeline and AMAG's ability to invest in such pipeline; plans to deliver innovative treatments and unlock shareholder value; beliefs regarding the impact, including on a go-forward basis, of the COVID-19 pandemic on AMAG's revenues, results of operations and overall business and industry; expectations for the Norgine arrangement, including the ability to unlock value in ciraparantag and invest in innovative therapies; beliefs about AMAG-423; plans to use streamlined operations and to optimize its pipeline; statements regarding 2020 financial guidance, including the expectation of achieving EBITDA positive and the impact of recent events on such guidance, such as the termination of the Palatin license agreement and costs associated with discontinuing the AMAG-423 trial, and statements about AMAG's ability to deliver long-term growth 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 scale and scope of the COVID-19 pandemic and its impact on AMAG's revenues and operations, including clinical trials, as well as COVID-19's impact on AMAG's business partners, healthcare providers, patients, employees and the health care industry and worldwide economies generally, risks related to AMAG's ability to manage the recently streamlined business and achieve anticipated results in a timely manner or at all, including any unintended consequences from such efforts; the possibility that AMAG's independent auditors will identify a material weakness as part of their review stemming from the immaterial accounting errors, or that they will identify other errors or corrections, including errors or corrections that could materially impact our financial statements and results provided in this press release; the accounting impact of AMAG's recent business development activity could have an impact on 2020 guidance; revenue expectations and estimates may be inaccurate, including as a result of regulatory action with respect to Makena or due to COVID-19, AMAG may not successfully develop and obtain approval for ciraparantag or may face challenges in supporting its relationship with Norgine, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 2020, and in any subsequent filings with the SEC, including AMAG's upcoming Form 10-Q for the quarter ended June 30, 2020 , 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.

    AMAG Pharmaceuticals®, the logo and designs, and Feraheme® are registered trademarks of AMAG Pharmaceuticals, Inc.   Makena® is a registered trademark of AMAG Pharma USA, Inc. Any other trademarks referred to in this report are the property of their respective owners.

    - Tables Follow -

    AMAG Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited, amounts in thousands, except for per share data)

     Three Months Ended June 30, Six Months Ended June 30,
     2020 2019 2020 2019
    Revenues:       
    Feraheme$29,635  $42,074  $74,068  $82,089 
    Makena22,325  30,593  45,888  61,534 
    Intrarosa1,216  4,877  4,385  9,291 
    Other(447) 90  (1,199) 133 
    Total product revenues52,729  77,634  123,142  153,047 
    Other revenues26  133  58  208 
    Total revenues52,755  77,767  123,200  153,255 
    Operating costs and expenses:       
    Cost of product sales18,180  24,290  42,539  42,767 
    Research and development expenses8,263  14,980  19,443  33,046 
    Acquired in-process research and development      74,856 
    Selling, general and administrative expenses39,568  77,324  92,266  152,006 
    Impairment of intangible assets  77,358    77,358 
    Gain on sale of assets(14,444)   (14,444)  
    Restructuring expenses8,197    8,197  7,420 
    Total costs and expenses59,764  193,952  148,001  387,453 
    Operating loss(7,009) (116,185) (24,801) (234,198)
            
    Other income (expense):       
    Interest expense(6,700) (6,330) (13,303) (12,780)
    Interest and dividend income327  1,224  804  2,810 
    Other (expense) income(22) 2  1,288  342 
    Total other expense, net(6,395) (5,104) (11,211) (9,628)
    Loss before income taxes(13,404) (121,289) (36,012) (243,826)
    Income tax benefit(160) (120) (60) (257)
    Net loss$(13,244) $(121,169) $(35,952) $(243,569)
            
    Basic and diluted net loss per share$(0.39) $(3.58) $(1.05) $(7.14)
            
    Weighted average shares outstanding used to compute net loss per share (basic and diluted)34,353  33,807  34,228  34,136 



    AMAG Pharmaceuticals, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited, amounts in thousands)

     June 30, 2020 December 31, 2019
    ASSETS   
    Current assets:   
    Cash and cash equivalents$98,521  $113,009 
    Marketable securities48,594  58,742 
    Accounts receivable, net65,104  94,163 
    Inventories30,388  31,553 
    Prepaid and other current assets20,950  19,100 
    Total current assets263,557  316,567 
    Property and equipment, net3,031  4,116 
    Goodwill422,513  422,513 
    Intangible assets, net3,946  23,620 
    Operating lease right-of-use asset22,007  23,286 
    Deferred tax assets  630 
    Restricted cash495  495 
    Total assets$715,549  $791,227 
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$12,944  $27,021 
    Accrued expenses144,567  183,382 
    Current portion of operating lease liability3,488  4,077 
    Current portion of acquisition-related contingent consideration  17 
    Total current liabilities160,999  214,497 
    Long-term liabilities:   
    Convertible notes, net285,137  277,034 
    Long-term operating lease liability19,263  19,791 
    Other long-term liabilities828  89 
    Total liabilities466,227  511,411 
    Commitments and contingencies   
    Stockholders' equity:   
    Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued   
    Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,463,373 and 33,999,081 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively344  339 
    Additional paid-in capital1,303,095  1,297,917 
    Accumulated other comprehensive loss(2,964) (3,239)
    Accumulated deficit(1,051,153) (1,015,201)
    Total stockholders' equity249,322  279,816 
    Total liabilities and stockholders' equity$715,549  $791,227 



    AMAG Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Cash Flows

    (Unaudited, amounts in thousands)

     Six Months Ended June 30,
     2020 2019
    Cash flows from operating activities:   
    Net loss$(35,952) $(243,569)
    Adjustments to reconcile net loss to net cash used in operating activities:   
    Depreciation and amortization19,791  9,089 
    Impairment of intangible assets  77,358 
    Provision for bad debt expense230  (12)
    Amortization of premium/discount on purchased securities42  (51)
    Write-down of inventory616  4,836 
    (Gain)/loss on disposal of property & equipment230   
    Non-cash equity-based compensation expense5,879  9,407 
    Non-cash IPR&D expense  18,029 
    Amortization of debt discount and debt issuance costs8,103  7,513 
    Gains on marketable securities, net(10) (270)
    Change in fair value of contingent consideration  (21)
    Deferred income taxes630  630 
    Non-cash lease expense1,279   
    Gain on sale of assets(15,853)  
    Changes in operating assets and liabilities:   
    Accounts receivable, net28,828  (7,825)
    Inventories(872) (3,323)
    Prepaid and other current assets(1,790) (5,562)
    Accounts payable and accrued expenses(53,494) 36,137 
    Deferred revenues  (101)
    Other assets and liabilities(377) 1,283 
    Net cash used in operating activities(42,720) (96,452)
    Cash flows from investing activities:   
    Proceeds from sales or maturities of marketable securities33,735  46,420 
    Purchase of marketable securities(23,345) (14,815)
    Net proceeds from the sale of assets19,344   
    Capital expenditures(790) (1,907)
    Net cash provided by investing activities28,944  29,698 
    Cash flows from financing activities:   
    Payments to settle convertible notes  (21,417)
    Payments of contingent consideration(17) (27)
    Payments for repurchases of common stock  (13,730)
    Proceeds from the issuance of common stock under the ESPP631  851 
    Proceeds from the exercise of common stock options  30 
    Payments of employee tax withholding related to equity-based compensation(1,326) (1,748)
    Net cash used in financing activities(712) (36,041)
    Net decrease in cash, cash equivalents, and restricted cash(14,488) (102,795)
    Cash, cash equivalents, and restricted cash at beginning of the period113,504  253,751 
    Cash, cash equivalents, and restricted cash at end of the period$99,016  $150,956 
    Supplemental data for cash flow information:   
    Cash (refunded) paid for taxes$(256) $433 
    Cash paid for interest$5,200  $5,467 
    Non-cash investing and financing activities:   
    Milestone payment accrued for FDA approval of Vyleesi$  $60,000 
    Settlement of note receivable in connection with Perosphere acquisition$  $10,000 
    Right-of-use assets obtained in exchange for lease liabilities$  $918 



    AMAG Pharmaceuticals, Inc.

    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

    Three Months Ended June 30, 2020

    (Unaudited, amounts in thousands)

     Revenue Cost of product sales Research & development Selling, general & administrative Gain on sale of assets Restructuring Operating Loss / Adjusted EBITDA
    GAAP$52,755   $18,180   $8,263   $39,568   $(14,444) $8,197   $(7,009)
    Depreciation and intangible asset amortization  (8,961) (74) (438)      
    Stock-based compensation  (104) 48  (2,037)      
    Gain on sale of assets        14,444     
    Restructuring          (8,197)  
    Non-GAAP Adjusted$52,755   $9,115   $8,237   $37,093   $—   $—   $(1,690)



    AMAG Pharmaceuticals, Inc.

    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

    Three Months Ended June 30, 2019

    (Unaudited, amounts in thousands)

     Revenue Cost of product sales Research & development Selling, general & administrative Intangible asset impairment charge Operating Loss / Adjusted EBITDA
    GAAP$77,767   $24,290   $14,980   $77,324   $77,358   $(116,185)
    Depreciation and intangible asset amortization  (3,943) (336) (434)    
    Stock-based compensation  (199) (680) (3,656)    
    Asset impairment  (4,836)     (77,358)  
    Non-GAAP Adjusted$77,767   $15,312   $13,964   $73,234   $—   $(24,743)



    AMAG Pharmaceuticals, Inc.

    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

    Six Months Ended June 30, 2020

    (Unaudited, amounts in thousands)

     Revenue Cost of product sales Research & development Selling, general & administrative Gain on sale of assets Restructuring Operating Loss / Adjusted EBITDA
    GAAP$123,200   $42,539   $19,443   $92,266   $(14,444) $8,197   $(24,801)
    Depreciation and intangible asset amortization  (18,798) (150) (843)      
    Stock-based compensation  (307) (23) (5,549)      
    Gain on sale of assets        14,444     
    Restructuring          (8,197)  
    Non-GAAP Adjusted$123,200   $23,434   $19,270   $85,874   $—   $—   $(5,378)



    AMAG Pharmaceuticals, Inc.

    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

    Six Months Ended June 30, 2019

    (Unaudited, amounts in thousands)

     Revenue Cost of product sales Research & development Selling, general & administrative Acquired IPR&D Intangible asset impairment charge Restructuring Operating Loss / Adjusted EBITDA
    GAAP$153,255   $42,767   $33,046   $152,006   $74,856   $77,358   $7,420   $(234,198)
    Depreciation and intangible asset amortization—   (7,886) (345) (858) —   —   —    
    Stock-based compensation—   (401) (1,360) (6,981) —   —   —    
    Acquisition-related costs—   —   —   (270) —   —   —    
    Asset impairment—   (4,836) —   —   —   (77,358) —    
    Restructuring—   —   —   —   —   —   (7,420)  
    Acquired IPR&D—   —   —   —   (74,856) —   —    
    Non-GAAP Adjusted$153,255   $29,644   $31,341   $143,897   $—   $—   $—   $(51,627)



    AMAG Pharmaceuticals, Inc.

    Reconciliation of GAAP to Non-GAAP 2020 Financial Guidance

    (Unaudited, amounts in thousands)

      2020 Financial Guidance
    Operating loss $(40) - $(15)
    Depreciation 30.0
    Stock-based compensation 11.0
    Gain on sale of assets (14.4)
    Restructuring 8.2
    Non-GAAP adjusted EBITDA $(5) - $20

    CONTACT:

    Rushmie Nofsinger

    781-530-6838

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  14. WALTHAM, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its second quarter 2020 financial results will be released on Thursday, August 6, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number
    U.S./Canada Dial-in Number: (877) 412-6083
    International Dial-in Number: (702) 495-1202
    Conference ID: 4548238

    Replay Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 4548238

    A telephone replay will be available from approximately 11:00 a.m. ET on August 6, 2020 through midnight on August 20, 2020…

    WALTHAM, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its second quarter 2020 financial results will be released on Thursday, August 6, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number

    U.S./Canada Dial-in Number: (877) 412-6083

    International Dial-in Number: (702) 495-1202

    Conference ID: 4548238

    Replay Dial-in Number: (855) 859-2056

    Replay International Dial-in Number: (404) 537-3406

    Conference ID: 4548238

    A telephone replay will be available from approximately 11:00 a.m. ET on August 6, 2020 through midnight on August 20, 2020

    The webcast with slides will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

    About AMAG

    AMAG is a commercial stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc. 

    AMAG Pharmaceuticals Contact:

    Loraine Spreen

    617-866-0303

    Primary Logo

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  15. Vyleesi® returned to Palatin Technologies

    Company focuses on optimizing marketed assets and development of its innovative pipeline

    WALTHAM, Mass., July 27, 2020 (GLOBE NEWSWIRE) --  AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced AMAG and Palatin Technologies, Inc. have mutually terminated the January 2017 license agreement pursuant to which AMAG was granted exclusive rights to develop and commercialize Vyleesi® (bremelanotide), a melanocortin receptor agonist indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, in North America.

    "Coupled with the recent sale of Intrarosa®, the return of Vyleesi to Palatin allows us to reduce operating expenses and prioritize the…

    Vyleesi® returned to Palatin Technologies

    Company focuses on optimizing marketed assets and development of its innovative pipeline

    WALTHAM, Mass., July 27, 2020 (GLOBE NEWSWIRE) --  AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced AMAG and Palatin Technologies, Inc. have mutually terminated the January 2017 license agreement pursuant to which AMAG was granted exclusive rights to develop and commercialize Vyleesi® (bremelanotide), a melanocortin receptor agonist indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, in North America.

    "Coupled with the recent sale of Intrarosa®, the return of Vyleesi to Palatin allows us to reduce operating expenses and prioritize the company's future value drivers – developing ciraparantag, maximizing Feraheme's value to address significant unmet medical needs, exploring portfolio partnering opportunities for our established brands and our pipeline, as well as retaining patient access to Makena," said Scott Myers AMAG's president and chief executive officer. "Palatin's long-standing commitment to the melanocortin platform enabled Vyleesi to be developed as the first as-needed treatment option for HSDD and under their leadership of the product, premenopausal women suffering from the condition will have continued access to the therapy."  

    Under the terms of the termination agreement, all of AMAG's rights and obligations to develop and commercialize Vyleesi under the license agreement will terminate, and full ownership of Vyleesi will transfer back to Palatin. AMAG will pay Palatin $12 million at closing and $4.3 million on March 31, 2021. In exchange for such payments, Palatin will assume all Vyleesi manufacturing agreements and associated minimum commitments and AMAG will transfer to Palatin all data and assets related exclusively to Vyleesi. Under the agreement, Palatin has agreed to compensate AMAG to provide certain transitional services to Palatin for a period of time to ensure continued patient access to Vyleesi during the transition back to Palatin.

    About Vyleesi® (bremelanotide injection)

    Vyleesi is approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The prefilled Vyleesi autoinjector pen is self-administered into a woman's abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day. Vyleesi is thought to possess a novel mechanism of action. While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system.

    The most common side effects of VYLEESI include nausea, flushing, injection site reactions, headache and vomiting.  Do not use VYLEESI if you are pregnant, or have uncontrolled hypertension, known heart disease or are taking oral naltrexone-containing products intended to treat opioid or alcohol addiction. Women who can become pregnant should use effective birth control during treatment with VYLEESI.

    For additional product information, including full prescribing information, please visit www.vyleesi.com

    ABOUT AMAG

    AMAG is a commercial stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    Forward Looking Statements

    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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 benefits of the sale of Intrarosa and Vyleesi to AMAG's strategy, including AMAG's ability to reduce operating expenses, optimize its marketed asset, maximize Feraheme's value, retain patient access to Makena or execute on partnering opportunities 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 scale and scope of the COVID-19 pandemic and its impact on AMAG's revenues and operations, as well as COVID-19's impact on AMAG's business partners, healthcare providers, patients, employees and the health care industry and worldwide economies generally, risks related to the divestiture of Intrarosa and Vyleesi, including any unintended consequences from such efforts and AMAG's ability to successfully achieve the expected benefits of such initiatives in a timely manner, or at all, risks that Feraheme could face increased competition in the near term, including as a result of the recent approval of Monoferric® or if Sandoz's ANDA is approved as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 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.

    AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Any other trademarks referred to in this report are the property of their respective owners.

    AMAG CONTACTS:

    Media:

    Rushmie Nofsinger

    (781) 530-6838

    Investors:

    Loraine Spreen

    617-866-0303

    Primary Logo

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  16. Agreement provides AMAG with $30 million upfront payment and eligibility to receive up to $260 million in development and commercial milestones in addition to sales royalties  

    Collaboration further advances the development of ciraparantag

    WALTHAM, Mass. and AMSTERDAM, The Netherlands, July 23, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) and Norgine B.V., a leading European specialist pharmaceutical company, today announced they have entered into an exclusive licensing agreement to develop and commercialize ciraparantag in Europe, Australia and New Zealand. Ciraparantag is in development for use in patients treated with direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH) when…

    Agreement provides AMAG with $30 million upfront payment and eligibility to receive up to $260 million in development and commercial milestones in addition to sales royalties  

    Collaboration further advances the development of ciraparantag

    WALTHAM, Mass. and AMSTERDAM, The Netherlands, July 23, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) and Norgine B.V., a leading European specialist pharmaceutical company, today announced they have entered into an exclusive licensing agreement to develop and commercialize ciraparantag in Europe, Australia and New Zealand. Ciraparantag is in development for use in patients treated with direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding.

    Under the terms of the license agreement, AMAG will receive $30 million of total upfront consideration and up to $260 million contingent upon the achievement of certain regulatory and sales milestones together with escalating double-digit royalties. Additionally, Norgine has committed to contribute one-third of the costs of the Phase 3 clinical program, which would be conducted by AMAG to support regulatory approval of ciraparantag by the U.S. Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare Products Regulatory Agency. AMAG will continue to oversee the Phase 3 clinical program, while working closely with Norgine. Norgine will be responsible for the regulatory filings and any subsequent clinical trials required for approval in its territory and will eventually hold all marketing authorizations in the licensed territories.

    "This agreement is a significant milestone on our strategic evolution. We are looking forward to partnering with Norgine and working together to unlock the value of ciraparantag, which will further strengthen our company's ability to continue investing in innovative therapies that address urgent unmet medical needs," said Scott Myers, AMAG's Chief Executive Officer. "Norgine's infrastructure and capabilities to develop and commercialize products will help us further advance the program into Phase 3 clinical trials and work towards regulatory approval in countries where providers and patients may benefit from a reversal agent."

    There are currently approximately six million patients in the U.S. and nine million patients in certain ex-U.S. countries on DOAC and LMWH therapy.1 A recent study found that approximately 1.5-2% of patients taking certain DOACs can be at risk for serious bleeding complications each year.2

    "We are delighted to enter into this new collaboration with AMAG to develop and commercialize ciraparantag in Europe, Australia and New Zealand," said Peter Stein, Chief Executive Officer of Norgine. "Patients who take anticoagulants can be at risk of serious and uncontrolled bleeding, especially in emergency situations, and we are proud to be able to support the development of a new, potentially life-saving treatment, subject to successful completion of ciraparantag's research programme and subsequent regulatory approval."

    About Ciraparantag

    Ciraparantag is a novel small, water-soluble molecule being investigated for reversal of anticoagulation induced by direct oral anticoagulants (DOACs) or low molecular weight heparin (LMWH). Target patient populations include patients for whom rapid reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding, or for emergency surgery or urgent procedures. It is believed that ciraparantag exerts its effects by binding to and blocking the effects of DOACs such as Xarelto® (rivaroxaban), Eliquis® (apixaban) and Savaysa® (edoxaban), as well as to the LMWH Lovenox® (enoxaparin sodium injection), which in turn reestablishes normal clot formation. Ciraparantag is administered by intravenous infusion; the anticipated clinical treatment regimen is a single dose administered over approximately 10 minutes. Ciraparantag has been studied across seven completed trials, with 277 subjects having been dosed with ciraparantag and has been well tolerated in these studies. To date, the most common adverse events related to ciraparantag have been mild transient sensations of warmth or skin flushing, skin tingling, and alterations in taste. The safety and efficacy of ciraparantag is under investigation through the ongoing clinical development program.

    ABOUT AMAG

    AMAG is a commercial stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    About Norgine

    Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 22 million patients around the world in 2019 and generated €419 million in net product sales, a growth of 6% over 2018.

    Norgine has a direct presence in 12 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialize specialist and innovative products that make a real difference to the lives of patients around the world.

    In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

    Forward Looking Statements

    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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 benefits of the transaction to AMAG's corporate strategy and strategic evolution, including its ability to unlock value in ciraparantag and continue investing in innovative therapies; beliefs about the benefits of the partnership on the development and regulatory approval of ciraparantag; beliefs about ciraparantag's potential benefits to patients; AMAG's expected plans related to the clinical development of ciraparantag and Phase 3 clinical program to support regulatory approval in the U.S., Europe, Australia, and New Zealand; statements regarding Norgine eventually holding all marketing authorizations in the licensed territories;  statements regarding the potential market size and target patient population; statements regarding ciraparantag, including its safety and mechanism of action, 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 scale and scope of the COVID-19 pandemic and its impact on AMAG's revenues and , operations, and clinical development (including, more specifically, the ciraparantag clinical development program), as well as COVID-19's impact on AMAG's business partners, healthcare providers, patients, employees and the health care industry and worldwide economies generally; uncertainties regarding AMAG's and Norgine's ability to successfully and timely complete clinical development programs and obtain regulatory approval for ciraparantag in the U.S., Europe, Australia and New Zealand, including as a result of clinical trial design or enrollment, or as a result of any safety or efficacy issues that may arise as part of such trial; the risk that the cost of the clinical development of ciraparantag will be more than planned or that the timeline will be significantly delayed; the risk that even if approved, the market for ciraparantag may be smaller than expected or AMAG and Norgine may not be successful in commercializing in such market or otherwise realize the expected benefits of the transaction; uncertainties regarding the manufacture of ciraparantag and our ability to supply Norgine; the risk that AMAG or Norgine will fail to fully perform their respective obligations under the license agreement; and those other risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 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.

    AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Any other trademarks referred to in this report are the property of their respective owners.

    AMAG Contacts:

    Investors:

    Rushmie Nofsinger

    (781) 530-6838

    Media:

    Stacy Nartker

    (781) 430-9212

    Norgine Contacts:

    Clara Bentham +44 (0)1895 826654 or +44 (0)7734 367883

    Eleni Fistikaki +44 (0)1895826227 or +44 (0)7825 389477



    www.norgine.com

    Follow us @norgine

    1 Perosphere sponsored commercial assessment report conducted by a third party in May 2016.

    2 Tepper, Ping G et al. (2018) Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, or rivaroxaban" PLoS ONE 13(11): e0205989. https://doi.org/10.1371/journal.pone.0205989

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  17. WALTHAM, Mass., July 12, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the poster presentation of data from two Phase 2 randomized, placebo-controlled, dose ranging studies which showed safety and efficacy of ciraparantag reversing the effects of apixaban and rivaroxaban in healthy adults age 50-75 years. The poster, "Efficacy and Safety of Ciraparantag in Reversing Apixaban and Rivaroxaban in Healthy Adults" was accepted for the 2020 International Society on Thrombosis and Haemostasis (ISTH) virtual annual meeting. Ciraparantag is in development for use in patients treated with direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products…

    WALTHAM, Mass., July 12, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the poster presentation of data from two Phase 2 randomized, placebo-controlled, dose ranging studies which showed safety and efficacy of ciraparantag reversing the effects of apixaban and rivaroxaban in healthy adults age 50-75 years. The poster, "Efficacy and Safety of Ciraparantag in Reversing Apixaban and Rivaroxaban in Healthy Adults" was accepted for the 2020 International Society on Thrombosis and Haemostasis (ISTH) virtual annual meeting. Ciraparantag is in development for use in patients treated with direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding.

    Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time (WBCT). WBCT is a direct measure of anticoagulation/hemostasis and a global measure of clotting. Mean WBCT values in the ciraparantag groups decreased toward baseline 15 minutes after dosing, versus placebo which took five hours commensurate with the decline of anticoagulant drug concentration. For reversal, defined as achieving a WBCT ≤10% above baseline within one hour after dosing and subsequently sustained through at least five hours, this response was achieved in 100 percent of subjects receiving ciraparantag doses ≥60 mg for reversal of apixaban, and 100 percent of subjects receiving ciraparantag doses of 180 mg for reversal of rivaroxaban. Ciraparantag was well tolerated at all doses evaluated in these studies. The most frequent adverse events associated with ciraparantag were mild, transient sensations of warmth or flushing, which were observed more frequently with higher doses of ciraparantag.

    "DOACs have become the dominant means for chronic anticoagulation, and there remains a need for an effective reversal agent with broad activity that can be administered quickly and conveniently for patients with serious uncontrolled bleeding or those who require emergency surgery," said Dr. Jack Ansell, Professor of Medicine, Hofstra Northwell School of Medicine. "These data are encouraging as they demonstrate a ciraparantag dose response for reversal of apixaban and rivaroxaban which, along with the safety findings, will inform dose selection for future studies."

    In the two studies, adult subjects were treated with apixaban or rivaroxaban and those who reached steady-state anticoagulation were randomized within each dose cohort in a 3:1 ratio to receive ciraparantag or placebo, which was administered three or four hours after last dose of the anticoagulant. Ciraparantag was administered as a single intravenous infusion over 10 minutes, followed by serial testing of WBCT over 24 hours. Doses of ciraparantag were evaluated at 30 mg, 60 mg and 120 mg for apixaban and 30 mg, 60 mg, 120 mg and 180 mg for rivaroxaban.

    About Ciraparantag

    Ciraparantag is a novel small, water-soluble molecule being investigated for reversal of anticoagulation induced by direct oral anticoagulants (DOACs) or low molecular weight heparin (LMWH). Target patient populations include patients for whom rapid reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding, or for emergency surgery or urgent procedures. It is believed that ciraparantag exerts its effects by binding to and blocking the effects of DOACs such as Xarelto® (rivaroxaban), Eliquis® (apixaban) and Savaysa® (edoxaban), as well as to the LMWH Lovenox® (enoxaparin sodium injection), which in turn reestablishes normal clot formation. Ciraparantag is administered by intravenous infusion; the anticipated clinical treatment regimen is a single dose administered over approximately 10 minutes. Ciraparantag has been studied across seven completed trials, with 277 subjects having been dosed with ciraparantag and has been well tolerated in these studies. To date, the most common adverse events related to ciraparantag have been mild transient sensations of warmth or skin flushing, skin tingling, and alterations in taste.

    ABOUT AMAG

    AMAG is a commercial stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    Forward Looking Statements

    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, AMAG's beliefs about the mechanism of action of ciraparantag and statements about ciraparantag, including the safety and efficacy, anticipated target patient population and dosing regimen for ciraparantag 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, the risk that ciraparantag is not approved as a reversal agent for a broad spectrum of anticoagulants, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 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.

    AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Any other trademarks referred to in this report are the property of their respective owners.

    AMAG CONTACTS:

    Investors:

    Loraine Spreen

    617-866-0303

    Media:

    Stacy Nartker

    (781) 430-9212

    Primary Logo

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  18. Company initiates CFO & COO succession plan; appoints internal seasoned finance leader as interim CFO

    Anthony Casciano assumes expanded role as AMAG's COO

    WALTHAM, Mass., June 11, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Edward (Ted) Myles, Chief Financial and Chief Operating Officer, is leaving the Company. Brian Piekos, Senior Vice President of Finance, has been appointed interim Chief Financial Officer and will become a member of the company's Executive Leadership Team. Anthony (Tony) Casciano has been appointed Chief Operating Officer and will add significant operational responsibilities to his role in addition to leading commercial operations. Both appointments are effective…

    Company initiates CFO & COO succession plan; appoints internal seasoned finance leader as interim CFO

    Anthony Casciano assumes expanded role as AMAG's COO

    WALTHAM, Mass., June 11, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Edward (Ted) Myles, Chief Financial and Chief Operating Officer, is leaving the Company. Brian Piekos, Senior Vice President of Finance, has been appointed interim Chief Financial Officer and will become a member of the company's Executive Leadership Team. Anthony (Tony) Casciano has been appointed Chief Operating Officer and will add significant operational responsibilities to his role in addition to leading commercial operations. Both appointments are effective immediately.

    "Our key priorities are to grow our core business, advance our pipeline and unlock shareholder value," said Scott Myers, AMAG's Chief Executive Officer. "AMAG's succession planning process ensures new leaders can contribute to advance the company. I'm excited to have Brian's experience, capabilities and deep financial acumen brought to the Executive Team, and the Board of Directors and I have full confidence in his leadership. Broadening Tony's role to include additional responsibilities will have a positive impact on AMAG's business and I look forward to partnering with him on refining our business practices and unlocking value. We appreciate the succession plan Ted has put into place and wish him well in his future endeavors."

    Mr. Piekos joined AMAG in 2015 and has held a number of senior management positions with the Company. In his most recent role as Senior Vice President of Finance, Mr. Piekos has provided oversight of AMAG's financial planning and reporting, tax, treasury and strategic sourcing processes. He has more than 20 years of corporate finance experience including strategic planning, financial reporting and capital market activities. Prior to AMAG, he held positions of increasing responsibility at Cubist Pharmaceuticals. Mr. Piekos began his career in investment banking having served as Vice President at Leerink Partners and as an analyst at Needham & Company.

    Mr. Casciano brings more than 20 years of commercial experience within the pharmaceutical industry. He joined AMAG in September 2016 and has since held positions of increasing responsibility with the Company. In his role as Chief Operating Officer, he will continue overseeing commercial activities, as well as technical operations, global supply chain and information technology for the Company. Prior to AMAG, Mr. Casciano spent 16 years career at Sanofi, where he held multiple commercial leadership roles across a range of departments and therapeutic areas. 

    ABOUT AMAG

    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    Forward Looking Statements

    This press release 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, statements regarding expectations with respect to the leadership changes and the impact on AMAG's business, 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 recent leadership changes, including potential disruption to the business and to management caused by leadership changes and succession efforts, and the potential impact on AMAG's ability to retain and hire talents, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 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.

    AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc.

    AMAG CONTACTS

    Investors & Media:

    Rushmie Nofsinger

    (781) 530-6838

    Primary Logo

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  19. Transaction allows AMAG to advance its strategic focus on Feraheme, Makena and its pipeline, consistent with previously announced plans

    Millicent Pharma uniquely positioned to drive revenue growth of Intrarosa

    WALTHAM, Mass., May 21, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced it has completed the sale of its rights to Intrarosa® (prasterone) to Millicent Pharma Limited, a global pharmaceutical company formed by the Millicent Pharma management team and The Carlyle Group in 2018 that specializes in women's health and menopause-related conditions, for up to $125 million, including upfront fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million. 

    "As mentioned…

    Transaction allows AMAG to advance its strategic focus on Feraheme, Makena and its pipeline, consistent with previously announced plans

    Millicent Pharma uniquely positioned to drive revenue growth of Intrarosa

    WALTHAM, Mass., May 21, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced it has completed the sale of its rights to Intrarosa® (prasterone) to Millicent Pharma Limited, a global pharmaceutical company formed by the Millicent Pharma management team and The Carlyle Group in 2018 that specializes in women's health and menopause-related conditions, for up to $125 million, including upfront fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million. 

    "As mentioned in our first quarter earnings release, the sale of Intrarosa is an important step in our strategic evolution," said Scott Myers AMAG's president and chief executive officer. "We were impressed with Millicent's commercial capabilities and dedication to women's healthcare and we are pleased to transition this important therapy into their portfolio. We remain focused on maximizing Feraheme's value, maintaining patient access to Makena and developing innovative therapies, while managing expenses to help further our goal of achieving profitability in 2020."

    In addition to the upfront consideration of $20 million, AMAG will be entitled to certain sales milestone payments, which include $25 million the first time Intrarosa net sales exceed $65 million during any consecutive 12-month period, a second sales milestone payment of $35 million the first time Intrarosa net sales exceed $115 million during any consecutive 12-month period, and a third milestone payment of $45 million the first time Intrarosa net sales exceed $175 million during any consecutive 12-month period.

    The sale of Intrarosa is consistent with AMAG's previously announced strategic decision to divest its women's health assets. AMAG has agreed to provide certain transitional services to Millicent Pharma for a limited period of time while Intrarosa is operationally separated from AMAG. AMAG remains committed to the divestiture of Vyleesi and associated expense reductions as previously announced.

    Goldman Sachs & Co. LLC served as exclusive financial advisor and Goodwin Procter LLP served as legal advisor to AMAG in connection with the transaction.

    ABOUT AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    Forward Looking Statements
    This press release 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, statements regarding AMAG's expectations with respect to the sale of its rights to Intrarosa, including the potential consideration payable in connection therewith, Millicent's ability to drive revenue growth of Intrarosa and successfully commercialize Intrarosa, the belief that the sale of Intrarosa is an important step in our strategic evolution, AMAG's plans to focus on maximizing Feraheme's value, maintaining patient access to Makena and developing innovative therapies, and expectations about managing expenses to help further AMAG's goal of achieving profitability in 2020, 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 sale of AMAG's rights to Intrarosa, including AMAG's ability to satisfy its obligations under the asset purchase and related agreements with Millicent, Millicent's ability to successfully commercialize Intrarosa and satisfy its obligations under the asset purchase and related agreements, AMAG's ability to achieve the expected benefits of the sale of Intrarosa to Millicent, AMAG's efforts to further streamline its business, including to divest Vyleesi and achieve the expected benefits therefrom, including any unintended consequences from such efforts, and AMAG's ability to successfully achieve the expected benefits of such initiatives in a timely manner, or at all, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 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.

    AMAG Pharmaceuticals®, the logo and designs, Feraheme® and Vyleesi® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Any other trademarks referred to in this report are the property of their respective owners.

    AMAG CONTACTS:
    Investors:
    Linda Lennox
    908-627-3424

    Media:
    Stacy Nartker
    (781) 430-9212

    Primary Logo

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  20. Feraheme® (ferumoxytol injection) posts strong first quarter results

    Company implements a workforce reduction of approximately 30 percent or 140 positions,
    as part of a planned decrease in operating expenses

    Conference call scheduled for 8:00 a.m. ET today

    WALTHAM, Mass., May 11, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the first quarter ended March 31, 2020. The company reported total revenues for the first quarter of 2020 of $68.7 million, including revenue of $44.4 million from Feraheme and revenue of $21.8 million from Makena® (hydroxyprogesterone caproate injection), as well as expense reductions across the business. The company also reported an operating…

    Feraheme® (ferumoxytol injection) posts strong first quarter results

    Company implements a workforce reduction of approximately 30 percent or 140 positions,
    as part of a planned decrease in operating expenses

    Conference call scheduled for 8:00 a.m. ET today

    WALTHAM, Mass., May 11, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the first quarter ended March 31, 2020. The company reported total revenues for the first quarter of 2020 of $68.7 million, including revenue of $44.4 million from Feraheme and revenue of $21.8 million from Makena® (hydroxyprogesterone caproate injection), as well as expense reductions across the business. The company also reported an operating loss of $19.6 million and an adjusted EBITDA loss of $5.5 million in the first quarter of 2020.1

    Despite strong first quarter results, AMAG's products are being impacted by the COVID-19 pandemic as patient visits have declined during this period. Given the planned divestiture of Intrarosa® (prasterone) and Vyleesi® (bremelanotide injection) and the impact of COVID-19, AMAG has implemented a company-wide restructuring, which will reduce the workforce by approximately 30 percent. AMAG is withdrawing its 2020 financial guidance due to the uncertainty surrounding the duration of the COVID-19 pandemic. 

    "We are sharpening our focus on our priorities of maximizing Feraheme's value, retaining patient access to Makena and continuing to efficiently develop innovative therapies, namely ciraparantag," said Scott Myers, AMAG's president and chief executive officer. "As we look to the future, it is difficult to estimate the severity and duration of the COVID-19 pandemic. We've seen signs of stabilization and remain confident in the underlying demand for our products; however, we cannot speculate on the subsequent speed of recovery and the overall impact on our business."

    "Based upon the extraordinary dynamics across the industry due to the COVID-19 pandemic, we have decided to withdraw our 2020 financial guidance," said Ted Myles, AMAG's chief financial officer and chief operating officer. "We remain committed to our previously stated goal of reducing total operating expenses by more than $100 million in 2020, as compared to 2019, and we are on track to achieve this objective. Furthermore, we continue to strive towards returning to profitability this year. The work force reduction that we announced today is an important step towards achieving these corporate objectives. While it was a difficult decision, we believe the organization is now the right size to support our long-term goals. We'd like to thank our colleagues who are leaving AMAG for their many contributions to our organization."

    OTHER KEY UPDATES
    Leadership Transition: AMAG announced in April that its Board of Directors appointed Scott Myers as AMAG's president and chief executive officer, and a member of the Board, effective immediately. Mr. Myers is a proven executive who brings nearly three decades of global pharmaceutical and medical technology experience to AMAG. Mr. Myers succeeds William Heiden who stepped down upon Mr. Myers' appointment.

    Supply Chain: At this time, all of the company's products remain available and the supply chain has not been materially affected by COVID-19. AMAG continues to closely monitor suppliers and supply levels. The company has risk mitigation plans in place to minimize potential supply interruptions, including redundant drug substance manufacturing and inventory safety stock, and will continue to work diligently with its suppliers to maintain continuous supply as the COVID-19 situation continues to evolve.

    Regulatory: In response to the company's request to the FDA for a meeting to discuss the future of Makena, the FDA indicated that it was premature to meet at this time as it was still reviewing the matter. AMAG remains committed to working collaboratively with the FDA to maintain access to Makena for eligible pregnant women.

    Clinical Trials: The COVID-19 pandemic is an evolving situation and is having a serious impact on clinical trials globally. The AMAG-423 Phase 2b/3a clinical trial is a hospital-based trial and all sites have paused new patient enrollment. The company has had to pause initiation of new sites due to the pandemic, significantly impacting recruitment and enrollment. AMAG continues to work with the FDA to initiate the ciraparantag Phase 2b trial in healthy volunteers in the U.S. However, the COVID-19 pandemic has forced the clinical trial sites where the company expected to conduct the trial to close.

    FIRST QUARTER ENDED MARCH 31
    Revenue
    First quarter revenue totaled $68.7 million, compared to $75.8 million for the same period in 2019. This decrease was primarily due to a decrease in sales of Makena stemming from the unfavorable FDA Advisory Committee recommendation for Makena in October 2019. These decreases were partially offset by an increase in sales of Feraheme.

    • Feraheme achieved first quarter revenue of $44.4 million, an increase of 11 percent over the same period last year. Feraheme's average quarterly market share was 17.2 percent in the first quarter of 2020, compared to 16.2 percent in the first quarter of 2019.
    • Makena first quarter revenue totaled $21.8 million, compared to $31.3 million in the first quarter of last year.
    • Intrarosa revenue in the first quarter of 2020 totaled $3.2 million, compared to $4.4 million in the same period last year.
    ($M) Three Months Ended March 31,
       2020
     2019
    Total revenues $68.7   $75.8  
    Feraheme   44.4     40.0  
    Makena   21.8     31.3  
    Intrarosa   3.2     4.4  
    Other   (0.7 )   0.1  

    Operating Expenses
    Total costs and expenses decreased by $105.3 million to $88.2 million in the first quarter of 2020, as compared to the first quarter of 2019. In the first quarter of last year, the company recorded $74.9 million of acquired in-process research and development (IPR&D) expense in connection with the acquisition of Perosphere Pharmaceuticals for the development asset, ciraparantag. Also recorded in the first quarter of last year was a one-time restructuring charge of $7.4 million related to combining the company's maternal health and women's health sales forces in February 2019.

    • Cost of products sales in the first quarter of 2020 increased by $5.9 million, as compared with the first quarter of last year, driven by an increase in amortization expense associated with the Makena, Intrarosa and Vyleesi intangible assets.
    • Research and development (R&D) expenses totaled $11.2 million, compared to $18.1 million in the first quarter of last year. This decrease was primarily related to lower costs for Vyleesi following its FDA approval in June 2019.
    • Selling, general and administrative (SG&A) expenses decreased by approximately $22.0 million, or 29 percent, in the first quarter of 2020, compared to the same period in 2019.
    ($M) Three Months Ended March 31,
       2020
    2019
    Amortization of intangible assets   $9.8     $3.9  
    Direct cost of product sales   14.5     14.5  
    Total cost of product sales   24.3     18.4  
    Research and development expenses   11.2     18.1  
    Acquired in-process research and development   —      74.9  
    Selling, general and administrative expenses   52.7     74.7  
    Restructuring expenses       7.4  
    Total costs and expenses   $88.2     $193.5  

    Balance Sheet

    • As of March 31, 2020, the company's cash and investments totaled $124.7 million.
    • Long-term debt totaled $320.0 million (representing the principal amounts outstanding of the 2022 convertible notes).

    Operating Loss and Adjusted EBITDA

    • The company reported an operating loss of $19.6 million in the first quarter of 2020, compared to an operating loss of $117.7 million in the same period last year.
    • The company reported a loss in adjusted EBITDA  of $5.5 million in the first quarter of 2020, compared to a loss in adjusted EBITDA of $26.6 million in the same period last year.
    ($M) Three Months Ended March 31,
       2020   2019 
    Operating loss   $(19.6 )   $(117.7 )
    Non-GAAP adjusted EBITDA1   $(5.5 )   $(26.6 )

    1 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release.

    CONFERENCE CALL AND WEBCAST ACCESS
    AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company's first quarter 2020 financial results and recent business updates.

    DIAL-IN NUMBERS
    U.S./Canada Dial-in Number: (877) 412-6083
    International Dial-in Number: (702) 495-1202
    Conference ID: 4948155

    Replay Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 4948155

    A telephone replay will be available from approximately 11:00 a.m. ET on May 11, 2020 through midnight on May 18, 2020.

    The webcast with slides will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

    USE OF NON-GAAP FINANCIAL MEASURES
    AMAG has presented certain non-GAAP financial measures, including non-GAAP costs and expenses, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization) and non-GAAP diluted shares outstanding. These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG's GAAP financial statements, because it provides greater transparency regarding AMAG's operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG's operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

    ABOUT AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    FORWARD-LOOKING STATEMENTS
    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, statements regarding AMAG's planned divestiture of Intrarosa and Vyleesi, expected results of and benefits from the workforce reduction, beliefs that AMAG can maximize Feraheme's value or retain patient access to Makena, expectations regarding the impact of the COVID-19 pandemic on AMAG's business, including signs of stabilization, beliefs about the demand for AMAG's products, plans to reduce total operating expenses by more than $100 million in 2020 and the belief that AMAG is on track to achieve that goal, beliefs that AMAG can undertake efforts to achieve profitability for 2020, beliefs that AMAG is now the right size to support long-term goals, statements related to the COVID-19 pandemic and its general impact, potential severity, duration and spread, beliefs that AMAG's risk mitigation plans will minimize potential supply interruptions due to the COVID-19 pandemic, beliefs that AMAG will be able to work collaboratively with the FDA to enable continued patient access to Makena, plans to work with the FDA to initiate the ciraparantag Phase 2b trial and estimates for Feraheme's market share 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 scale and scope of the COVID-19 pandemic and its impact on AMAG's revenues and operations, including clinical trials, as well as COVID-19's impact on AMAG's business partners, healthcare providers, patients, employees and the health care industry and worldwide economies generally, risks related to efforts to streamline the business, including the workforce reduction and the planned divestiture of Intrarosa and Vyleesi, including any unintended consequences from such efforts and AMAG's ability to successfully achieve the expected benefits of such initiatives in a timely manner, or at all, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 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.

    AMAG Pharmaceuticals®, the logo and designs, Feraheme® and Vyleesi® are registered trademarks of AMAG Pharmaceuticals, Inc.  Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc.  Any other trademarks referred to in this report are the property of their respective owners.

    - Tables Follow -


    AMAG Pharmaceuticals, Inc.
    Condensed Consolidated Statements of Operations
    (Unaudited, amounts in thousands, except for per share data)

      Three Months Ended March 31,
      2020   2019
    Revenues:      
    Feraheme $ 44,433     $ 40,015  
    Makena 21,777     31,257  
    Intrarosa 3,169     4,414  
    Other (751 )   43  
    Total product revenues 68,628     75,729  
    Other revenues 33     75  
    Total revenues 68,661     75,804  
    Operating costs and expenses:      
    Cost of product sales 24,359     18,477  
    Research and development expenses 11,180     18,066  
    Acquired in-process research and development     74,856  
    Selling, general and administrative expenses 52,697     74,682  
    Restructuring expenses     7,420  
    Total costs and expenses 88,236     193,501  
    Operating loss (19,575 )   (117,697 )
           
    Other income (expense):      
    Interest expense (6,604 )   (6,450 )
    Interest and dividend income 477     1,586  
    Other income 1,311     340  
    Total other expense, net (4,816 )   (4,524 )
    Loss before income taxes (24,391 )   (122,221 )
    Income tax expense (benefit) 100     (137 )
    Net loss $ (24,491 )   $ (122,084 )
           
    Basic and diluted net loss per share $ (0.72 )   $ (3.54 )
           
    Weighted average shares outstanding used to compute net loss per share (basic and diluted) 34,104     34,469  
               


    AMAG Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets
    (Unaudited, amounts in thousands)

      March 31, 2020   December 31, 2019
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 54,455     $ 113,009  
    Marketable securities 70,288     58,742  
    Accounts receivable, net 106,484     94,163  
    Inventories 33,676     31,553  
    Prepaid and other current assets 25,734     19,100  
    Total current assets 290,637     316,567  
    Property and equipment, net 3,312     4,116  
    Goodwill 422,513     422,513  
    Intangible assets, net 13,783     23,620  
    Operating lease right-of-use asset 22,835     23,286  
    Deferred tax assets     630  
    Restricted cash 495     495  
    Total assets $ 753,575     $ 791,227  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable $ 16,520     $ 27,021  
    Accrued expenses 167,661     177,079  
    Current portion of operating lease liability 4,065     4,077  
    Current portion of acquisition-related contingent consideration     17  
    Total current liabilities 188,246     208,194  
    Long-term liabilities:      
    Convertible notes, net 281,038     277,034  
    Long-term operating lease liability 19,433     19,791  
    Other long-term liabilities 1,120     89  
    Total liabilities 489,837     505,108  
    Commitments and contingencies      
    Stockholders' equity:      
    Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued      
    Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,266,256
    and 33,999,081 shares issued and outstanding at March 31, 2020 and December 31,
    2019, respectively
    342     339  
    Additional paid-in capital 1,300,572     1,297,917  
    Accumulated other comprehensive loss (3,787 )   (3,239 )
    Accumulated deficit (1,033,389 )   (1,008,898 )
    Total stockholders' equity 263,738     286,119  
    Total liabilities and stockholders' equity $ 753,575     $ 791,227  
     


    AMAG Pharmaceuticals, Inc.
    Condensed Consolidated Statements of Cash Flows
    (Unaudited, amounts in thousands)

      Three Months Ended March 31,
      2020   2019
    Cash flows from operating activities:      
    Net loss $ (24,491 )   $ (122,084 )
    Adjustments to reconcile net loss to net cash (used in) provided by operating activities:      
    Depreciation and amortization 10,318     4,375  
    Provision for bad debt expense 223     (16 )
    Amortization of premium/discount on purchased securities 4     (27 )
    Write-down of inventory 616      
    Non-cash equity-based compensation expense 3,868     4,873  
    Non-cash IPR&D expense     18,029  
    Amortization of debt discount and debt issuance costs 4,004     3,783  
    Gains on marketable securities, net (9 )    
    Change in fair value of contingent consideration     (6 )
    Deferred income taxes 630     458  
    Non-cash lease expense 451      
    Gain on sale of assets (1,409 )    
    Changes in operating assets and liabilities:      
    Accounts receivable, net (12,547 )   (7,971 )
    Inventories (2,770 )   (2,973 )
    Prepaid and other current assets (6,490 )   (21,580 )
    Accounts payable and accrued expenses (19,671 )   31,432  
    Other assets and liabilities 664     1,799  
    Net cash used in operating activities (46,609 )   (89,908 )
    Cash flows from investing activities:      
    Proceeds from sales or maturities of marketable securities 11,255     27,945  
    Purchase of marketable securities (23,345 )   (14,815 )
    Net proceeds from the sale of assets 1,440      
    Capital expenditures (68 )   (1,794 )
    Net cash (used in) provided by investing activities (10,718 )   11,336  
    Cash flows from financing activities:      
    Payments to settle convertible notes     (21,417 )
    Payments of contingent consideration (17 )   (17 )
    Payments for repurchases of common stock     (13,730 )
    Proceeds from the exercise of common stock options     33  
    Payments of employee tax withholding related to equity-based compensation (1,210 )   (1,636 )
    Net cash used in financing activities (1,227 )   (36,767 )
    Net decrease  in cash, cash equivalents, and restricted cash (58,554 )   (115,339 )
    Cash, cash equivalents, and restricted cash at beginning of the period 113,504     253,751  
    Cash, cash equivalents, and restricted cash at end of the period $ 54,950     $ 138,412  
    Supplemental data for cash flow information:      
    Cash (refunded) paid for taxes $ (256 )   $ 78  
    Cash paid for interest $     $ 267  
    Non-cash investing and financing activities:      
    Settlement of note receivable in connection with Perosphere acquisition $     $ 10,000  
    Right-of-use assets obtained in exchange for lease liabilities $     $ 918  
                   


    AMAG Pharmaceuticals, Inc.
    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
    Three Months Ended March 31, 2020
    (Unaudited, amounts in thousands)

      Revenue   Cost of product
    sales
      Research &
    development
      Selling, general &
    administrative
      Operating Loss /
    Adjusted EBITDA
    GAAP $ 68,661      $ 24,359      $ 11,180      $ 52,697      $ (19,575 )
    Depreciation and intangible asset amortization     (9,837 )   (76 )   (405 )    
    Stock-based compensation     (203 )   (70 )   (3,512 )    
    Non-GAAP Adjusted $ 68,661      $ 14,319      $ 11,034      $ 48,780      $ (5,472 )
     


    AMAG Pharmaceuticals, Inc.
    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
    Three Months Ended March 31, 2019
    (Unaudited, amounts in thousands)

      Revenue   Cost of product sales   Research & development   Selling, general & administrative   Acquired
    IPR&D
      Restructuring   Operating Loss / Adjusted EBITDA
    GAAP $ 75,804      $ 18,477      $ 18,066      $ 74,682      $ 74,856      $ 7,420      $ (117,697 )
    Depreciation and intangible asset amortization     (3,943 )   (8 )   (424 )            
    Stock-based compensation     (202 )   (680 )   (3,325 )            
    Acquisition-related costs             (270 )            
    Restructuring                     (7,420 )    
    Acquired IPR&D                 (74,856 )        
    Non-GAAP Adjusted $ 75,804      $ 14,332      $ 17,378      $ 70,663      $ —      $ —      $ (26,569 )
     


    AMAG Pharmaceuticals, Inc.
    Share Count Reconciliation
    (Unaudited, amounts in millions)

        Three Months Ended March 31,  
        2020   2019  
    Weighted avg. basic and diluted shares outstanding   34.1    34.5   
    Employee equity incentive awards   0.2 2 0.2 3
    Non-GAAP diluted shares outstanding   34.3    34.7   
     

    2 Employee equity incentive awards would be anti-dilutive in this period.
    3 Reflects the non-GAAP dilutive impact of employee equity incentive awards.

    CONTACT:
    Linda Lennox
    908-627-3424

     

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  21. WALTHAM, Mass., April 28, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its Board of Directors has appointed Scott Myers as AMAG's President and Chief Executive Officer, and member of the Board, effective immediately. Mr. Myers succeeds William Heiden, who is stepping down from such roles in light of Mr. Myers' appointment.

    "Scott is a seasoned leader with exceptional experience, skill set and passion, and it became evident to the Board through its rigorous search that Scott is the ideal candidate to lead AMAG forward," said Gino Santini, Chairman of AMAG's Board. "Scott's track record of success, coupled with his experience leading companies with development stage and commercialized assets, uniquely…

    WALTHAM, Mass., April 28, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its Board of Directors has appointed Scott Myers as AMAG's President and Chief Executive Officer, and member of the Board, effective immediately. Mr. Myers succeeds William Heiden, who is stepping down from such roles in light of Mr. Myers' appointment.

    "Scott is a seasoned leader with exceptional experience, skill set and passion, and it became evident to the Board through its rigorous search that Scott is the ideal candidate to lead AMAG forward," said Gino Santini, Chairman of AMAG's Board. "Scott's track record of success, coupled with his experience leading companies with development stage and commercialized assets, uniquely positions him to lead the Company. The Board is confident that Scott will maximize AMAG's strengths and proven capabilities and enable the Company to better serve patients."

    Mr. Santini added, "The Board of Directors would like to thank Bill for his dedication and leadership over the past eight years. We appreciate Bill's contributions to AMAG and we wish him the best in his future endeavors."

    Mr. Myers is a proven executive who brings nearly three decades of global pharmaceutical and medical technology experience to AMAG. Mr. Myers most recently served as Chairman and Chief Executive Officer of Rainier Therapeutics, a clinical-stage biotechnology company focused on metastatic bladder cancer. Prior to joining Rainier, Mr. Myers served as Chief Executive Officer, President and as a director of Cascadian Therapeutics Inc. Mr. Myers also served as Chief Executive Officer of Aerocrine AB, a medical device company from 2011 to 2015. While at the helm of these companies, Mr. Myers drove transformation that maximized growth and delivered significant long-term value.

    "AMAG is at a pivotal point in its evolution and I look forward to working with AMAG's Board, its leadership team and its dedicated employees to advance the strategic plan, further define the Company's future, optimize its current products and bring innovative therapies to patients in need," said Mr. Myers. "We have a significant opportunity ahead of us to unlock the potential of AMAG's pipeline and leverage its existing commercial strengths to drive long-term growth and shareholder value."

    Mr. Myers is currently an independent director of Selecta Biosciences where he serves as the Chair of the Compensation and Benefits Committee, as well as a member of the Nominating and Governance Committee. Mr. Myers also serves as an independent director for Harpoon Therapeutics, a clinical stage biotechnology company where he serves on the Audit Committee. Mr. Myers began his career in management consulting and then moved into the pharmaceutical industry through senior leadership roles at Johnson & Johnson, DOV Pharmaceuticals and UCB.

    Mr. Myers holds a Bachelor of Arts in Biology from Northwestern University in Evanston, Illinois, and a Master of Business Administration from The University of Chicago Graduate School of Business (Booth) in Chicago, Illinois.

    Inducement Equity Awards
    The Board of Directors of AMAG approved an inducement award to Mr. Myers of an option to purchase 1,000,000 shares of common stock. The option will have an exercise price equal to the closing price of AMAG's common stock on the grant date and will be exercisable in four equal annual installments beginning on the first anniversary of April 28,2020 (the grant date). The option will have a ten-year term and be subject to the terms and conditions of the stock option agreement pursuant to which the option will be granted. This equity award will be granted without stockholder approval as inducements material to the employee entering into employment with AMAG in accordance with NASDAQ Listing Rule 5635(c)(4).

    ABOUT AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    FORWARD-LOOKING STATEMENTS
    This press release 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 of the Board of Directors that Mr. Myers' experience and skills will maximize the value of AMAG's strengths and capabilities and enable the Company to better serve patients; AMAG's expectations for the leadership transition, including expectations and beliefs regarding AMAG's ability to successfully achieve benefits from the appointment of Mr. Meyers as President and Chief Executive Officer; and Mr. Myers' expectations that AMAG will advance its strategic plan, optimize its current products and bring innovative therapies to patients and unlock the potential of AMAG's pipeline and leverage its existing commercial strengths to drive long-term growth and shareholder value 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 risk that AMAG will be unable to successfully achieve the anticipated benefits from the appointment of Mr. Myers are Chief Executive Officer and President, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, and 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.

    AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc.

    AMAG CONTACTS:
    Investors:
    Linda Lennox
    908-627-3424

    Media:
    Sarah Connors
    781-296-0722

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  22. WALTHAM, Mass., April 27, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its first quarter 2020 financial results will be released on Monday, May 11, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number
    U.S./Canada Dial-in Number: (877) 412-6083
    International Dial-in Number: (702) 495-1202
    Conference ID: 4948155

    Replay Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 4948155

    A telephone replay will be available from approximately 11:00 a.m. ET on May 11, 2020 through midnight on May 18, 2020.

    The webcast with…

    WALTHAM, Mass., April 27, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its first quarter 2020 financial results will be released on Monday, May 11, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number
    U.S./Canada Dial-in Number: (877) 412-6083
    International Dial-in Number: (702) 495-1202
    Conference ID: 4948155

    Replay Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 4948155

    A telephone replay will be available from approximately 11:00 a.m. ET on May 11, 2020 through midnight on May 18, 2020.

    The webcast with slides will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

    About AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc. 

    AMAG Pharmaceuticals Contact:
    Loraine Spreen
    617-866-0303

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  23. WALTHAM, Mass., April 16, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today provided an update regarding the potential impact of COVID-19 on the company. AMAG is committed to the health and safety of its employees, patients, healthcare providers, business partners and communities and is following the guidance from the Center for Disease Control (CDC) and Prevention and local public health authorities, including implementing a work from home policy for all employees.

    All products currently remain available to patients. At this time, the company's supply chain has not been materially affected by COVID-19 and the company continues to closely monitor suppliers and supply levels. The company has risk mitigation plans in place…

    WALTHAM, Mass., April 16, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today provided an update regarding the potential impact of COVID-19 on the company. AMAG is committed to the health and safety of its employees, patients, healthcare providers, business partners and communities and is following the guidance from the Center for Disease Control (CDC) and Prevention and local public health authorities, including implementing a work from home policy for all employees.

    All products currently remain available to patients. At this time, the company's supply chain has not been materially affected by COVID-19 and the company continues to closely monitor suppliers and supply levels. The company has risk mitigation plans in place to minimize potential supply interruptions, including redundant drug substance manufacturing and inventory safety stock, and will continue to work diligently with its suppliers to maintain continuous supply as the COVID-19 situation evolves.

    The COVID-19 pandemic is an evolving situation and is having an impact on clinical trials globally. The company continues to assess potential impacts to its current clinical development activities for the ongoing AMAG-423 Phase 2b/3a clinical trial and the planned ciraparantag Phase 2b trial in healthy volunteers. The company believes that the COVID-19 pandemic is adversely impacting its current development timelines, including delaying new site initiation and patient enrollment.

    Similarly, the company believes the COVID-19 pandemic will impact its business operations and associated financial performance, primarily due to reduced patient visits to healthcare providers. The company plans to provide further updates during its first quarter 2020 earnings review in early May.

    ABOUT AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging our development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    FORWARD-LOOKING STATEMENTS
    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, beliefs about the expected impact of COVID-19 on the company's operations 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, uncertainty as to the impact of the COVID-19 pandemic, the scope, breadth and duration of which is unknown and rapidly evolving, on AMAG's revenues and results of operations; the risk that AMAG's protocols and mitigation efforts will not be successful to avoid or minimize business disruptions; the ability of patients and healthcare providers to receive and administer AMAG's products, particularly as resources and availability of space and services at hospitals, physician's officer and other sites of care are strained to support the response to COVID-19; the impact of COVID-19 on AMAG's business development activities; the risk that the supply chain for Feraheme®, Makena®, Intrarosa® and/or Vyleesi® will be interrupted as a result of the COVID-19 pandemic; the impact on AMAG's operations and financial results from the spread of COVID-19 in the geographies and industries where AMAG and its suppliers and business partners operate, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, and any subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and any other subsequent filings with the SEC, which are or will be 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.

    AMAG Pharmaceuticals®, the logo and designs, Feraheme® and Vyleesi ® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc.

    CONTACT:
    Linda Lennox
    908-627-3424

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  24. WALTHAM, Mass., March 04, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2019. Total revenues for the full year of 2019 totaled $327.8 million, including revenue of $167.9 million from Feraheme® (ferumoxytol injection), revenue of $122.1 million from Makena® (hydroxyprogesterone caproate injection), and revenue of $21.4 million from Intrarosa® (prasterone). The company reported an operating loss of $445.5 million and an adjusted EBITDA loss of $65.0 million in 2019.1

    "Our financial results reported today reflect the successes and challenges of 2019. While we achieved record revenue for Feraheme and gained our third…

    WALTHAM, Mass., March 04, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2019. Total revenues for the full year of 2019 totaled $327.8 million, including revenue of $167.9 million from Feraheme® (ferumoxytol injection), revenue of $122.1 million from Makena® (hydroxyprogesterone caproate injection), and revenue of $21.4 million from Intrarosa® (prasterone). The company reported an operating loss of $445.5 million and an adjusted EBITDA loss of $65.0 million in 2019.1

    "Our financial results reported today reflect the successes and challenges of 2019. While we achieved record revenue for Feraheme and gained our third FDA approval in two years, we faced some challenges, namely the readout of the PROLONG study and the October Advisory Committee for Makena," said William Heiden, AMAG's president and chief executive officer. "We acknowledged the Makena challenges in our recently-completed strategic review, resulting in our decision to divest Intrarosa and Vyleesi®. We believe this decision will position the company well to focus on the continuing development of ciraparantag and AMAG-423, drive continued growth of Feraheme, and continue our work to retain patient access to Makena. Preparing for the future, the board of directors has initiated a search for my successor to lead the company on the next leg of the AMAG journey, serving shareholders and patients with unmet medical needs."

    FINANCIAL RESULTS FOR THE PERIODS ENDED DECEMBER 31
    Fourth Quarter Financial Results

    ($M) Three Months Ended December 31,
      2019   2018
    Revenues $ 89.7     $ 88.1  
    Feraheme 41.7     35.2  
    Makena 25.6     46.9  
    Intrarosa 6.5     5.9  
    Other product revenue (0.4 )   0.1  
    Collaboration revenue 16.3      
    Costs and expenses $ 283.6     $ 106.9  
    Cost of product sales 43.3     28.7  
    Research and development 16.5     12.2  
    Selling, general and administrative expenses 68.8     66.0  
    Impairment of assets 155.0      
    Operating loss $ (193.9 )   $ (18.8 )
    Adjusted EBITDA1 $ (5.8 )   $ 1.5  

    ____________________________
    1 See summaries of GAAP to non-GAAP adjustments at conclusion of this press release.

    Revenues
    During the fourth quarter ended December 31, 2019 revenue totaled $89.7 million, compared with $88.1 million for the same period in 2018.

    • In the fourth quarter of 2019 sales of Feraheme totaled $41.7 million, compared with $35.2 million in the same period in 2018, sales of Makena totaled $25.6 million, compared with $46.9 million in the same period in 2018, and sales of Intrarosa totaled $6.5 million, compared with $5.9 million in the same period in 2018.
    • Included in revenue for the fourth quarter of 2019 was $16.3 million of collaboration revenue recognized in connection with a termination and settlement agreement entered into with Daiichi Sankyo, Inc. (DSI) related to a clinical trial collaboration agreement that AMAG acquired as part of the Perosphere acquisition. Under the terms of the settlement agreement with DSI, AMAG received $10.0 million in cash and recognized an additional $6.3 million of deferred revenue in December 2019.

    Costs and Expenses
    Costs and expenses in the fourth quarter ended December 31, 2019 totaled $283.6 million, compared with $107.0 million in the same period in 2018.

    • During the fourth quarter of 2019, the company identified indicators of impairment for the Makena subcutaneous auto-injector, Intrarosa and Vyleesi asset groups related to i) the unfavorable FDA Advisory Committee recommendation for Makena on October 29, 2019 and ii) the completion of a strategic review, which resulted in the company's intention to divest Intrarosa and Vyleesi. Total impairment charges of $155.0 million were recorded in a separate operating expense line in the fourth quarter of 2019.

    Operating Loss and Adjusted EBITDA

    • The company reported an operating loss in the fourth quarter ended December 31, 2019 of $193.9 million, which included the $155.0 million of impairment charges discussed above, compared to an operating loss of $18.8 million for the same period last year.
    • The company reported an adjusted EBITDA loss of $5.8 million in the fourth quarter of 2019, compared with adjusted EBITDA of $1.5 million for the same period last year.1

    Full Year Financial Results
    ($M) Twelve Months Ended December 31,
      2019   2018
    Revenues $ 327.8     $ 474.0  
    Feraheme 167.9     135.0  
    Makena 122.1     322.3  
    Intrarosa 21.4     16.2  
    Other product revenue (0.2 )   0.4  
    Collaboration and other revenue 16.6     0.1  
    Costs and expenses $ 773.3     $ 521.0  
    Cost of product sales 107.2     215.9  
    Research and development 64.9     44.8  
    Acquired in-process research and development 74.9     32.5  
    Selling, general and administrative expenses 286.6     227.8  
    Impairment of assets 232.3      
    Restructuring 7.4      
    Operating loss $ (445.5 )   $ (47.0 )
    Adjusted EBITDA1 $ (65.0 )   $ 120.8  

    Revenues
    Revenues totaled $327.8 million in 2019, compared with $474.0 million in 2018.

    • Feraheme achieved record revenue of $167.9 million in 2019, an increase of 24% over 2018, and market share of 17.7%. The overall IV iron market grew 12.0% in 2019 from 2018.
    • Makena revenues totaled $122.1 million in 2019, compared with $322.3 million in 2018. This decrease was primarily due to a decrease in sales of the Makena intramuscular (IM) product caused by IM supply disruptions and generic competition, which resulted in the company ultimately removing the IM product, including its authorized generic, from the market. Partially offsetting the decrease in Makena IM revenues was an increase in Makena subcutaneous auto-injector revenues.
    • Intrarosa revenues increased 32% to $21.4 million in 2019, compared with $16.2 million in 2018.

    Costs and Expenses
    Costs and expenses in 2019 totaled $773.3 million, compared with $521.0 million in 2018. This increase includes i) impairment charges of $232.3 million related to second quarter impairment charges of $77.4 million and the fourth quarter impairment charges described earlier, ii) a $74.9 million acquired in-process research and development charge related to the acquisition of Perosphere Pharmaceuticals, which closed in the first quarter of 2019, and iii) a restructuring charge of $7.4 million related to combining the Maternal Health and Women's Health sales forces in the first quarter of 2019.

    • Cost of product sales decreased $108.7 million year-over-year, primarily due to a decrease in amortization related to the Makena IM product that was fully impaired in the second quarter of 2019.
    • SG&A expenses increased $58.8 million to $286.6 million in 2019, compared with $227.8 million in 2018. SG&A expenses in 2018 included a reversal of $49.6 million related to a Makena sales milestone that the company determined was not likely to be paid. Excluding this expense reversal, SG&A increased by $9.2 million, which was primarily driven by the commercial launch of Vyleesi in September 2019.
    • Research and development expenses increased $20.0 million to $64.9 million in 2019, primarily related to the development costs for the ciraparantag and AMAG-423 programs.

    Operating Loss and Adjusted EBITDA

    • The company reported an operating loss of $445.5 million in 2019, compared with an operating loss of $47.0 million in 2018.
    • The company reported an adjusted EBITDA loss of $65.0 million in 2019, compared with adjusted EBITDA of $120.8 million in 2018.1

    Balance Sheet

    • As of December 31, 2019, the company's cash and investments totaled $171.8 million.
    • As of December 31, 2019 long-term debt totaled $320.0 million (representing the principal amount outstanding of the 2022 convertible notes).

    "Despite the challenges that the company faced throughout 2019, the growth in Feraheme revenues emerged as a bright spot for the year. Even with a soft fourth quarter for Makena, we managed our spend to achieve our adjusted EBITDA financial guidance for the year," said Ted Myles, AMAG's chief operating officer and chief financial officer. "For 2020, we have guided to a return to profitability based on revenues of $255 million at the midpoint. We believe that our capital allocation strategy, which includes the divestiture of Intrarosa and Vyleesi and associated expense reductions, positions us well to focus on our core value drivers. AMAG's unique portfolio combines the opportunity to generate positive cash flows from commercial products while advancing a potentially exciting pipeline of development products."

    2020 FINANCIAL GUIDANCE2
    The company reaffirms the following financial guidance for 2020.

    ($M) 2020 Financial Guidance
    Total revenue $230 - $280
    Operating income $2 - $32
    Non-GAAP adjusted EBITDA $20 - $50

    2 See reconciliation of 2020 GAAP to non-GAAP financial guidance at conclusion of this press release.

    2020 KEY PRIORITIES

    • Complete successful CEO transition 
    • Divest Intrarosa and Vyleesi to align with the new strategic direction 
    • Drive continued Feraheme growth 
    • Work with the FDA to maintain patient access to Makena  
    • Advance ciraparantag and AMAG-423 development programs  
    • Pursue ex-U.S. portfolio partnering opportunities 
    • Meet or exceed financial guidance 

    CONFERENCE CALL AND WEBCAST ACCESS
    AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. EST to discuss the company's fourth quarter and full year 2019 financial results.

    DIAL-IN NUMBER
    U.S./Canada Dial-in Number: (877) 412-6083
    International Dial-in Number: (702) 495-1202
    Conference ID: 5865557

    Replay Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 5865557

    A telephone replay will be available from approximately 11:00 a.m. ET on March 4, 2020 through midnight on March 11, 2020.

    The webcast with slides will be accessible through the Investors section of AMAG's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

    USE OF NON-GAAP FINANCIAL MEASURES
    AMAG has presented certain non-GAAP financial measures, including non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG's GAAP financial statements, because it provides greater transparency regarding AMAG's operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG's operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release.

    ABOUT AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging our development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women's health. For additional company information, please visit www.amagpharma.com.

    FORWARD-LOOKING STATEMENTS
    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, beliefs about the performance of AMAG's commercially available products; beliefs regarding AMAG's ability to drive continued Feraheme growth; expectations for ciraparantag and AMAG-423 studies, including development timelines; AMAG's expectations regarding its ability to successfully divest Intrarosa and Vyleesi and the effect and amount of associated expense reductions; AMAG's expectations regarding its ability to ensure continued patient access to Makena and the associated effect on cash flow; beliefs regarding AMAG's ability to return to profitability; expectations that AMAG remains on track to return to positive adjusted EBITDA in 2020 and other 2020 financial guidance; plans to search for a successor to AMAG's president and chief executive officer, and the ability to affect a smooth transition William Heiden and the ability to effect a successful transition; plans to pursue ex-U.S. portfolio partnering opportunities; 2020 financial guidance, including forecasted GAAP revenue and operating loss and non-GAAP adjusted EBITDA; and beliefs regarding AMAG's ability to optimize the value of its portfolio to maximize shareholder value 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 that the FDA will withdraw approval of Makena in line with the recommendation of the Advisory Committee; the FDA could take other adverse action related to Makena given the findings and recommendation of the Advisory Committee; AMAG may not be able to generate additional efficacy data that will be satisfactory to the FDA (if the FDA permits AMAG to submit additional data to support or as a condition to the continued commercialization of Makena); healthcare providers may be reluctant to continue to prescribe the Makena auto-injector or the FDA may require that the Makena label include information on the PROLONG study, restrictions to the current indication or the insertion of new warnings or precautions; AMAG is unable to generate sufficient cash to satisfy its debt obligations and could face challenges undertaking fundraising, restructuring or strategic transactions in order to meet these obligations, including under convertible notes due June 1, 2022; AMAG will be significantly dependent on sales of Feraheme to support its ongoing operations, including its development pipeline, and Feraheme could face increased competition in the near term, including as a result of the recent approval of Monoferric® or if Sandoz's ANDA is approved; that AMAG  will face difficulties or delays in appointing a chief executive officer to succeed Mr. Heiden or otherwise be unable to successfully transition to a new CEO; AMAG will not be able to divest Intrarosa or Vyleesi in the expected timeframe, or at all, or that any transaction will be on terms that are favorable to AMAG or that yield any value for its shareholders; that the anticipated benefits of such a divestiture, including anticipated expense reductions, will not be realized at expected levels, or at all; that AMAG may be unable to gain approval of its product candidates, including AMAG-423 and ciraparantag, on a timely basis, or at all; that such approvals, if obtained, will include unanticipated restrictions or warnings and that the costs and time investments for AMAG's development efforts will be higher than anticipated, or that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including AMAG-423 and ciraparantag; that AMAG will be unable to successfully identify and enter into partnerships with out-licensees for its product candidates in ex-U.S. territories, which could delay the commercialization of those product candidates in certain geographies, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019, and subsequent filings with the SEC (including its upcoming Annual Report on Form 10-K for the year ended December 31, 2019), 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. AMAG Pharmaceuticals®, the logo and designs, Feraheme® and Vyleesi ® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Other trademarks referred to in this report are the property of their respective owners.

    - Tables Follow -


    AMAG Pharmaceuticals, Inc.
    Condensed Consolidated Statements of Operations
    (unaudited, amounts in thousands, except for per share data)

      Three Months Ended December 31,   Year Ended December 31,
      2019   2018   2019   2018
    Revenues:              
    Feraheme $ 41,653     $ 35,204     $ 167,947     $ 135,001  
    Makena 25,601     46,888     122,064     322,265  
    Intrarosa 6,520     5,888     21,417     16,218  
    Other (395 )   67     (238 )   368  
    Total product sales, net 73,379     88,047     311,190     473,852  
    Collaboration revenue 16,299         16,400      
    Other revenue 31     75     161     150  
    Total revenues 89,709     88,122     327,751     474,002  
    Costs and expenses:              
    Cost of product sales 43,322     28,716     107,193     215,892  
    Research and development expenses 16,476     12,211     64,853     44,846  
    Acquired in-process research and development         74,856     32,500  
    Selling, general and administrative expenses 68,873     66,030     286,600     227,810  
    Impairment of assets 154,978         232,336      
    Restructuring expenses         7,420      
    Total costs and expenses 283,649     106,957     773,258     521,048  
    Operating loss (193,940 )   (18,835 )   (445,507 )   (47,046 )
    Other income (expense):              
    Interest expense (6,510 )   (6,571 )   (25,709 )   (51,971 )
    Loss on debt extinguishment             (35,922 )
    Interest and dividend income 636     2,120     4,285     5,328  
    Other (expense) income (134 )   (10 )   428     (74 )
    Total other expense, net (6,008 )   (4,461 )   (20,996 )   (82,639 )
    Loss from continuing operations before income taxes (199,948 )   (23,296 )   (466,503 )   (129,685 )
    Income tax (benefit) expense (21 )   (2,550 )   (47 )   39,654  
    Net loss from continuing operations (199,927 )   (20,746 )   (466,456 )   (169,339 )
                   
    Discontinued operations:              
    Income from discontinued operations             18,873  
    Gain on sale of CBR business     (2,506 )       87,076  
    Income tax expense     (975 )       2,371  
    Net (loss) income from discontinued operations     (1,531 )       103,578  
                   
    Net loss $ (199,927 )   $ (22,277 )   $ (466,456 )   $ (65,761 )
                   
    Basic and diluted earnings per share:              
    Loss from continuing operations $ (5.89 )   $ (0.60 )   $ (13.71 )   $ (4.92 )
    Income from discontinued operations     (0.04 )       3.01  
    Total $ (5.89 )   $ (0.64 )   $ (13.71 )   $ (1.91 )
                   
    Weighted average shares outstanding used to compute earnings per share (basic and diluted): 33,945     34,560     34,030     34,394  
                   


    AMAG Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets
    (unaudited, amounts in thousands)

      December 31, 2019   December 31, 2018
    ASSETS      
    Current assets:      
    Cash and cash equivalents $ 113,009     $ 253,256  
    Marketable securities 58,742     140,915  
    Accounts receivable, net 94,163     75,347  
    Inventories 31,553     26,691  
    Prepaid and other current assets 19,100     18,961  
    Note receivable     10,000  
    Total current assets 316,567     525,170  
    Property and equipment, net 4,116     7,521  
    Goodwill 422,513     422,513  
    Intangible assets, net 23,620     217,033  
    Operating lease right-of-use asset 23,286      
    Deferred tax assets 630     1,260  
    Restricted cash 495     495  
    Other long-term assets     1,467  
    Total assets $ 791,227     $ 1,175,459  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current liabilities:      
    Accounts payable $ 27,021     $ 14,487  
    Accrued expenses 177,079     129,537  
    Current portion of convertible notes, net     21,276  
    Current portion of operating lease liability 4,077      
    Current portion of acquisition-related contingent consideration 17     144  
    Total current liabilities 208,194     165,444  
    Long-term liabilities:      
    Convertible notes, net 277,034     261,933  
    Long-term operating lease liability 19,791      
    Long-term acquisition-related contingent consideration     215  
    Other long-term liabilities 89     1,212  
    Total liabilities 505,108     428,804  
           
    Commitments and Contingencies (Note P)      
    Stockholders' equity:      
    Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued      
    Common stock, par value $0.01 per share, 117,500,000 shares authorized; 33,999,081 and 34,606,760 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively 339     346  
    Additional paid-in capital 1,297,917     1,292,736  
    Accumulated other comprehensive loss (3,239 )   (3,985 )
    Accumulated deficit (1,008,898 )   (542,442 )
    Total stockholders' equity 286,119     746,655  
    Total liabilities and stockholders' equity $ 791,227     $ 1,175,459  


    AMAG Pharmaceuticals, Inc.
    Condensed Consolidated Statements of Cash Flows
    (unaudited, amounts in thousands, except for per share data)

      Years Ended December 31,
      2019   2018
    Cash flows from operating activities:      
    Net loss $ (466,456 )   $ (65,761 )
    Adjustments to reconcile net loss to net cash (used in) provided by operating activities:      
    Depreciation and amortization 27,324     172,223  
    Impairment of long-lived assets 232,336      
    Provision for bad debt expense     678  
    Amortization of premium/discount on purchased securities (95 )   87  
    Write-down of inventory 19,767     5,176  
    (Gain) loss on disposal of fixed assets     (99 )
    Non-cash equity-based compensation expense 19,198     19,916  
    Non-cash IPR&D expense 18,029      
    Loss on debt extinguishment     35,922  
    Amortization of debt discount and debt issuance costs 15,242     15,658  
    (Gain) loss on sale of marketable securities, net (265 )   (1 )
    Change in fair value of contingent consideration (270 )   (49,607 )
    Deferred income taxes 404     41,166  
    Non-cash lease expense 2,725      
    Gain on sale of the CBR business     (87,076 )
    Transaction costs     (14,111 )
    Changes in operating assets and liabilities:      
    Accounts receivable, net (18,816 )   16,995  
    Inventories (19,253 )   (454 )
    Prepaid and other current assets (113 )   (6,097 )
    Accounts payable and accrued expenses 52,747     (32,568 )
    Deferred revenues (6,400 )   8,658  
    Other assets and liabilities (1,800 )   95  
    Net cash (used in) provided by operating activities (125,696 )   60,800  
    Cash flows from investing activities:      
    Proceeds from sales or maturities of marketable securities 98,321     85,342  
    Purchases of marketable securities (14,815 )   (89,956 )
    Milestone payment for Vyleesi developed technology (60,000 )    
    Proceeds from the sale of the CBR business     519,303  
    Note receivable     (10,000 )
    Capital expenditures (2,544 )   (2,534 )
    Net cash provided by investing activities 20,962     502,155  
    Cash flows from financing activities:      
    Long-term debt principal payments     (475,000 )
    Payments to repurchase 2019 Convertible Notes (21,417 )    
    Payment of premium on debt extinguishment     (28,054 )
    Payment of contingent consideration (72 )   (119 )
    Payments for repurchases of common stock (13,730 )    
    Proceeds from the issuance of common stock under the ESPP 1,506      
    Proceeds from the exercise of common stock options 30     3,881  
    Payments of employee tax withholding related to equity-based compensation (1,830 )   (2,682 )
    Net cash used in financing activities (35,513 )   (501,974 )
    Net (decrease) increase in cash, cash equivalents and restricted cash (140,247 )   60,981  
    Cash, cash equivalents and restricted cash at beginning of the year 253,751     192,770  
    Cash, cash equivalents and restricted cash at end of the year $ 113,504     $ 253,751  
           
    Supplemental data of cash flow information:      
    Cash (refunded) paid for taxes $ (202 )   $ 5,345  
    Cash paid for interest $ 10,667     $ 48,757  
    Non-cash investing and financing activities:      
    Right-of-use assets obtained in exchange for lease obligations $ 18,455     $  
    Settlement of note receivable in connection with Perosphere acquisition $ 10,000     $  


    AMAG Pharmaceuticals, Inc.
    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
    Three Months Ended December 31, 2019
    (unaudited, amounts in thousands)

      Revenue   Cost of product sales   Research & development   Selling, general & administrative   Asset impairment charges   Operating Loss / Adjusted EBITDA
    GAAP $ 89,709     $ 43,322     $ 16,476     $ 68,873     $ 154,978     $ (193,940 )
    Depreciation and intangible asset amortization     (12,666 )   (101 )   (684 )        
    Stock-based compensation     (245 )   (793 )   (3,779 )        
    Charges related to impairment     (14,893 )           (154,978 )    
    Non-GAAP Adjusted $ 89,709     $ 15,518     $ 15,582     $ 64,410     $     $ (5,801 )


    AMAG Pharmaceuticals, Inc.
    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
    Three Months Ended December 31, 2018
    (unaudited, amounts in thousands)

      Revenue   Cost of product sales   Research & development   Selling, general & administrative   Operating Loss / Adjusted EBITDA
    GAAP $ 88,122     $ 28,716     $ 12,211     $ 66,030     $ (18,835 )
    Depreciation and intangible asset amortization     (13,714 )   (9 )   (372 )    
    Non-cash inventory step-up adjustments     (126 )            
    Stock-based compensation     (215 )   (637 )   (4,465 )    
    Adjustments to contingent consideration             432      
    Acquisition related costs             (1,257 )    
    Non-GAAP Adjusted $ 88,122     $ 14,661     $ 11,565     $ 60,368     $ 1,528  


    AMAG Pharmaceuticals, Inc.
    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
    Twelve Months Ended December 31, 2019
    (unaudited, amounts in thousands)

      Revenue   Cost of product sales   Research & development   Selling, general & administrative   Asset impairment charges   Acquired IPR&D   Restructuring   Operating Loss / Adjusted EBITDA
    GAAP $ 327,751     $ 107,193     $ 64,853     $ 286,600     $ 232,336     $ 74,856     $ 7,420     $ (445,507 )
    Depreciation and intangible asset amortization     (24,764 )   (572 )   (1,988 )                
    Stock-based compensation     (871 )   (2,844 )   (14,818 )                
    Acquired IPR&D                     (74,856 )        
    Charges related to impairment     (19,729 )           (232,336 )            
    Restructuring charges                         (7,420 )    
    Acquisition related costs             (270 )                
    Non-GAAP Adjusted $ 327,751     $ 61,829     $ 61,437     $ 269,524     $     $     $     $ (65,039 )


    AMAG Pharmaceuticals, Inc.
    Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
    Twelve Months Ended December 31, 2018
    (unaudited, amounts in thousands)

      Revenue   Cost of product sales   Research & development   Selling, general & administrative   Acquired IPR&D   Operating Loss / Adjusted EBITDA
    GAAP $ 474,002     $ 215,892     $ 44,846     $ 227,810     $ 32,500     $ (47,046 )
    Depreciation and intangible asset amortization     (158,446 )   (21 )   (1,592 )        
    Non-cash inventory step-up adjustments     (3,728 )                
    Stock-based compensation     (802 )   (2,533 )   (16,614 )        
    Adjustments to contingent consideration             49,607          
    Acquired IPR&D                 (32,500 )    
    Acquisition related costs             (1,257 )        
    Non-GAAP Adjusted $ 474,002     $ 52,916     $ 42,292     $ 257,954     $     $ 120,840  


    AMAG Pharmaceuticals, Inc.
    Reconciliation of 2019 Financial Guidance of Non-GAAP Adjusted EBITDA
    (Unaudited, amounts in millions)

    Operating income $2 - $32
    Depreciation 2
    Stock-based compensation 16
    Adjusted EBITDA $20 - $50


    AMAG Pharmaceuticals, Inc.
    Share Count Reconciliation
    (unaudited, amounts in millions)

      Three Months Ended December 31,   Twelve Months Ended December 31,  
      2019   2018   2019   2018  
    Weighted average basic shares outstanding 33.9     34.6     34.0     34.4    
    Employee equity incentive awards   3   3   3   3
    GAAP diluted shares outstanding 33.9     34.6     34.0     34.4    
    Employee equity incentive awards   4 0.3   4   4 0.3   4
    Non-GAAP diluted shares outstanding 33.9     34.9     34.0     34.7    

    3 Employee equity incentive awards would be anti-dilutive in this period.
    4 Reflects the non-GAAP dilutive impact of employee equity incentive awards.


    CONTACTS:
    Investors:
    Linda Lennox
    908-627-3424

    Media:
    Sarah Connors
    781-296-0722 

    Primary Logo

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  25. WALTHAM, Mass., March 04, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced changes to its medical development organization. Effective March 31, 2020, Julie Krop, M.D., Executive Vice President and Chief Medical Officer, will be leaving the Company. As AMAG initiates a search for a permanent Chief Medical Officer, the Board of Directors and management will continue to work closely with the medical development organization on key priorities, including working with the U.S. Food and Drug Administration (FDA) to find a path to retain patient and provider access to Makena® and advancing the ciraparantag and AMAG-423 clinical development programs.

    "Tenured leadership across our medical development organization has…

    WALTHAM, Mass., March 04, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced changes to its medical development organization. Effective March 31, 2020, Julie Krop, M.D., Executive Vice President and Chief Medical Officer, will be leaving the Company. As AMAG initiates a search for a permanent Chief Medical Officer, the Board of Directors and management will continue to work closely with the medical development organization on key priorities, including working with the U.S. Food and Drug Administration (FDA) to find a path to retain patient and provider access to Makena® and advancing the ciraparantag and AMAG-423 clinical development programs.

    "Tenured leadership across our medical development organization has helped us achieve our most recent regulatory approvals and the team remains focused on supporting our portfolio of products to address unmet medical needs," said William Heiden, AMAG's President and Chief Executive Officer. "We appreciate all the contributions that Dr. Krop has made to our organization and wish her well in her future endeavors."

    Over the past several years, AMAG has built out a fully integrated development organization to support the Company's pipeline of development-stage products. The Company will leverage the team's expertise and experience across clinical operations, medical affairs, biostatistics, regulatory affairs and pharmacovigilance as it works with the FDA to retain patient access to Makena and advance the ciraparantag and AMAG-423 clinical development programs.

    Additionally, former board member Lesley Russell, MBChB, MRCP will provide further, interim expertise as Clinical Consultant, effective immediately. Dr. Russell has three decades of experience in clinical development and regulatory affairs, and will advise the company during the transition to a new CMO.

    ABOUT AMAG 
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com. 

    FORWARD-LOOKING STATEMENTS
    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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: AMAG's expectations for the leadership transition, including the planned timing for the search for a new chief medical officer; expectations that AMAG's Board of Directors, remaining management team and Dr. Russell will continue to work with the company's medical development organization on the company's key priorities during the search for a new chief medical officer and successfully support AMAG's products; AMAG's expectations regarding continued patient and provider access to Makena and the advancement of its clinical development programs for ciraparantag and AMAG-423; expectations that Dr. Milton will continue to lead AMAG's regulatory strategy to retain patient access to Makena during the search for a new chief medical officer; and expectations and beliefs regarding AMAG's ability to successfully achieve benefits from its leadership transition plan, including managing the search for and transition to a new chief medical officer, 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 that the FDA will withdraw approval of Makena in line with the recommendation of the Advisory Committee; that the FDA could take other adverse action related to Makena given the findings and recommendation of the Advisory Committee; that AMAG may not be able to generate additional efficacy data that will be satisfactory to the FDA (if the FDA permits AMAG to submit additional data to support or as a condition to the continued commercialization of Makena); that healthcare providers may be reluctant to continue to prescribe the Makena auto-injector or the FDA may require that the Makena label include information on the PROLONG study, restrictions to the current indication or the insertion of new warnings or precautions; that AMAG is unlikely generate sufficient cash to satisfy its debt obligations and could face challenges undertaking fundraising, restructuring or strategic transactions in order to meet these obligations, including under convertible notes due June 1, 2022; that AMAG will be significantly dependent on sales of Feraheme to support its ongoing operations, including its development pipeline, and Feraheme could face increased competition in the near term, including as a result of the recent approval of Monoferric® or if Sandoz's ANDA is approved; that AMAG will face difficulties or delays in appointing a chief executive officer to succeed Mr. Heiden or a chief medical officer to succeed Dr. Krop or otherwise be unable to successfully execute its leadership transition plan; that AMAG will not be able to identify or effect any transaction to divest Intrarosa or Vyleesi in the expected timeframe, or at all, or that any transaction will be on terms that are favorable to AMAG or that yield any value for its shareholders; that the anticipated benefits of such a divestiture, including anticipated expense reductions, will not be realized at expected levels, or at all; that AMAG may be unable to gain approval of its product candidates, including AMAG-423 and ciraparantag, on a timely basis, or at all; that such approvals, if obtained, will include unanticipated restrictions or warnings and that the costs and time investments for AMAG's development efforts will be higher than anticipated, or that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including AMAG-423 and ciraparantag; that AMAG will be unable to successfully identify and enter into partnerships with out-licensees for its product candidates in ex-U.S. territories, which could delay the commercialization of those product candidates in certain geographies, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019, and subsequent filings with the SEC (including its upcoming Annual Report on Form 10-K for the year ended December 31, 2019), 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.

    AMAG Pharmaceuticals®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc.

    AMAG CONTACTS:
    Investors:
    Linda Lennox
    908-627-3424

    Media:
    Sarah Connors
    (781) 296-0722


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  26. WALTHAM, Mass., Feb. 28, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its fourth quarter and full year 2019 financial results will be released on Wednesday, March 4, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number
    U.S./Canada Dial-in Number: (877) 412-6083
    International Dial-in Number: (702) 495-1202
    Conference ID: 5865557

    Replay Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 5865557

    A telephone replay will be available from approximately 11:00 a.m. ET on March 4, 2020 through midnight on March 11…

    WALTHAM, Mass., Feb. 28, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its fourth quarter and full year 2019 financial results will be released on Wednesday, March 4, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number
    U.S./Canada Dial-in Number: (877) 412-6083
    International Dial-in Number: (702) 495-1202
    Conference ID: 5865557

    Replay Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 5865557

    A telephone replay will be available from approximately 11:00 a.m. ET on March 4, 2020 through midnight on March 11, 2020.

    The webcast with slides will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

    About AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc. 

    AMAG Pharmaceuticals Contact:
    Loraine Spreen
    617-866-0303

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  27. WALTHAM, Mass., Feb. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that management will participate in the following investor conferences:

    • SVB Leerink 9th Annual Global Healthcare Conference
      Wednesday, February 26, 2020 at 2:30 pm EST
      Location: New York, NY

    • Cowen and Company 40th Annual Health Care Conference
      Wednesday, March 4, 2020 at 10:40 am EST
      Location: Boston, MA

    • Barclays Global Healthcare Conference
      Wednesday, March 12, 2020 at 8:30 am EST
      Location: Miami Beach, FL

    A live audio webcast of each event will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of each webcast will be archived on the company's website for 30 days.

    About AMAG
    AMAG is a pharmaceutical…

    WALTHAM, Mass., Feb. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that management will participate in the following investor conferences:

    • SVB Leerink 9th Annual Global Healthcare Conference
      Wednesday, February 26, 2020 at 2:30 pm EST
      Location: New York, NY

    • Cowen and Company 40th Annual Health Care Conference
      Wednesday, March 4, 2020 at 10:40 am EST
      Location: Boston, MA

    • Barclays Global Healthcare Conference
      Wednesday, March 12, 2020 at 8:30 am EST
      Location: Miami Beach, FL

    A live audio webcast of each event will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of each webcast will be archived on the company's website for 30 days.

    About AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc. 

    AMAG Pharmaceuticals Contact:
    Loraine Spreen
    617-866-0303

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  28. Initiating CEO transition plan

    Divesting Intrarosa® and Vyleesi®

     2020 financial guidance reflects reduction in annual operating expenses of more than $100M and a return to positive adjusted EBITDA

    WALTHAM, Mass., Jan. 09, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the initiation of a leadership transition, the decision to divest Intrarosa and Vyleesi and financial updates.

    Leadership Transition & Business Updates
    AMAG announced that William Heiden plans to step down as AMAG's President and Chief Executive Officer, and that the Company's Board of Directors will immediately initiate a search for his successor, which it expects to complete by mid-2020. Mr. Heiden will remain in his role as President and…

    Initiating CEO transition plan

    Divesting Intrarosa® and Vyleesi®

     2020 financial guidance reflects reduction in annual operating expenses of more than $100M and a return to positive adjusted EBITDA

    WALTHAM, Mass., Jan. 09, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the initiation of a leadership transition, the decision to divest Intrarosa and Vyleesi and financial updates.

    Leadership Transition & Business Updates
    AMAG announced that William Heiden plans to step down as AMAG's President and Chief Executive Officer, and that the Company's Board of Directors will immediately initiate a search for his successor, which it expects to complete by mid-2020. Mr. Heiden will remain in his role as President and CEO until a successor is appointed.

    AMAG also recently completed a robust review of its product portfolio and strategy and engaged Goldman Sachs and Co., LLC as its financial advisor to assist in the review. The guiding principles for this strategic review included driving near- and long-term profitability and enhancing shareholder value. As a result of this review, AMAG will divest Intrarosa® (prasterone) and Vyleesi® (bremelanotide). The Company has received preliminary expressions of interest to acquire/sub-license the rights to these products. AMAG's 2020 financial guidance indicates a return to positive adjusted EBITDA, reflecting the continued growth of Feraheme® (ferumoxytol injection) and a significant reduction in operating expenses, primarily associated with the divestiture of Intrarosa and Vyleesi. The 2020 revenue guidance reflects a range of potential revenue scenarios for Makena® (hydroxyprogesterone caproate injection) given the uncertainty caused by the FDA Advisory Committee meeting and soft fourth quarter results.

    "The strategic decisions announced today will allow AMAG to leverage its commercial strengths and proven development and regulatory capabilities while focusing on core value drivers: developing ciraparantag and AMAG-423; driving the continued growth of Feraheme, which funds our two pipeline assets; and continuing our work to retain patient access to Makena," said Mr. Heiden. "It has been an honor and a privilege to lead the team at AMAG. We've achieved numerous successes and overcome many challenges. As we implement the strategic shift announced today, my fellow directors and I believe that this is the right time for the board to identify a new CEO for the next leg of AMAG's journey."

    Mr. Heiden added, "We continue to believe in the significant long-term potential of Intrarosa and Vyleesi. However, the uncertainty around the long-term durability of Makena revenues makes it challenging to invest in both our promising pipeline and in the physician and consumer marketing required to support these two new products. Given the significant future commercial potential of ciraparantag and AMAG-423 to fulfill unmet medical needs of patients, AMAG made the difficult decision to divest Intrarosa and Vyleesi. The Company is seeking a transaction with a party that can make the investments necessary to maximize the value of these two important women's healthcare products."

    In addition to the announced CEO transition, Chief Financial Officer Ted Myles will assume the additional role of Chief Operating Officer, effective immediately, expanding his responsibilities to include technical operations, global supply chain and quality. General Counsel Joseph Vittiglio will assume the additional role of Chief Business Officer, focusing on managing the divestiture of Intrarosa and Vyleesi and out-licensing opportunities in ex-U.S. territories, primarily for AMAG's development-stage programs. 

    Gino Santini, Chairman of AMAG's Board, said, "The Board is committed to pursuing strategies that will unlock value for AMAG shareholders and better leverage the Company's strengths and proven capabilities. We are confident that taking the strategic actions announced today will position AMAG for future growth and enable the Company to better serve patients."

    Mr. Santini continued, "The Board would like to thank Bill for his visionary leadership, transforming AMAG from a single-product company to one with an in-house clinical development team that has gained three FDA product approvals in the last two years, and is progressing two late-stage development products through the regulatory process. For nearly eight years, Bill developed and executed on strategies to invest in products that have benefited hundreds of thousands of patients and which hold the potential of reaching many more in the future. The Board looks forward to working with Bill on a seamless transition, as well as continuing to work with AMAG's outstanding executive leadership team to drive near- and long-term results."

    Preliminary 2019 Financial Results and 2020 Financial Guidance
    AMAG announced preliminary unaudited fourth quarter and full year 2019 financial results and provided 2020 financial guidance, reflecting the Company's focus on profitability in 2020. The Company expects to report final financial results for the fourth quarter and audited results for the full year of 2019 in early March.

    Preliminary, Unaudited Fourth Quarter Financial Results
    ($M) Three Months Ended December 31, 2018
      2019 Preliminary     2018 Actual
     
    Total revenues, net $86 - $91     $88.1  
    Feraheme 40 - 42     35.2  
    Makena 24 - 27     46.9  
    Intrarosa 6.5     5.9  
    Other product revenue (0.5 )   0.1  
    Collaboration revenue1 16     --  
    Operating loss2 ($22) - ($12 )   ($18.8 )
    Non-GAAP adjusted EBITDA3 ($10) - $0     $1.5  


    Preliminary, Unaudited Full Year Financial Results
    ($M) Twelve Months Ended December 31, 2018
      2019 Preliminary
        2018 Actual  
    Total revenues, net $324 - $329     $474.0  
    Feraheme 167 - 169     135.4  
    Makena 120 - 123     322.3  
    Intrarosa 21     16.2  
    Other product revenue (1 )   0.1  
    Collaboration revenue1 16     --  
    Operating loss2 ($274) - ($264 )   ($47.0 )
    Non-GAAP adjusted EBITDA3 ($70) - ($60 )   $120.8  

    The Company ended 2019 with approximately $170 million in cash and investments and $320 million of 2022 convertible notes (principal amount outstanding).

    Key priorities for 2020 include:

    • Complete successful CEO transition
    • Divest Intrarosa and Vyleesi to align with the new strategic direction
    • Drive continued Feraheme growth
    • Work with the FDA to maintain patient access to Makena
    • Advance ciraparantag and AMAG-423 development programs
    • Pursue ex-US portfolio partnering opportunities
    • Meet/exceed financial guidance
    2020 Financial Guidance4  
    ($M)  
    Total revenue $230 - $280
    Operating income $2 - $32
    Non-GAAP adjusted EBITDA $20 - $50

    Mr. Myles stated, "With the divestiture of Intrarosa and Vyleesi and the associated expense reductions, the AMAG of 2020 will be more streamlined and focused to drive Feraheme growth, support the development of our two pipeline assets and deliver positive adjusted EBITDA. While we remain committed to working with the FDA to maintain patient access to Makena, we will be managing Makena-related expenses so that the product is cash flow positive. Our financial guidance includes a reduction of operating expenses of more than $100 million in 2020 relative to 2019. We believe our 2020 plan, including the revised capital allocation strategy, maintains our strong commitment to patients and best positions AMAG to generate sustainable, long-term shareholder value."

    INFORMATION FOR LIVE AUDIO WEBCAST AT THE 38TH J.P. MORGAN HEALTHCARE CONFERENCE
    The Company will provide a live update at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 16, 2020 at 9:30 a.m. PT (12:30 p.m. ET). A live audio webcast of the presentation and the following breakout session will be accessible in the Investors section of AMAG's website at www.amagpharma.com. on January 16, 2020 at 9:30 a.m. PT (12:30 p.m. ET). Following the conference, the webcast will be archived on the Company's website until February 17, 2020.

    USE OF NON-GAAP FINANCIAL MEASURES 
    AMAG has presented certain non-GAAP financial measures, including non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG's GAAP financial statements, because it provides greater transparency regarding AMAG's operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG's operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release. 

    ABOUT AMAG 
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women's health. For additional company information, please visit www.amagpharma.com. 

    FORWARD-LOOKING STATEMENTS
    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, AMAG's beliefs that the leadership transition and divestiture of Intrarosa and Vyleesi will allow AMAG to leverage its commercial strengths and development and regulatory capabilities and position AMAG for future growth; expectations for the leadership transition, including the timing to complete the CEO search; plans to work with the FDA regarding patient access to Makena; beliefs related to the significant long-term potential of Intrarosa and Vyleesi and the significant future commercial potential of AMAG-423 and ciraparantag; expectations that AMAG will return to positive adjusted EBITDA and be able to unlock shareholder value; plans to reduce operating expenses; beliefs that Feraheme revenues will continue to grow; expectations that AMAG's full year 2019 revenues and adjusted EBITDA will be within its most recently issued financial guidance range; 2019 preliminary fourth quarter and full year financial results, including revenues, operating loss and adjusted EBITDA; AMAG's 2020 key priorities, including expectations and beliefs regarding (i) AMAG's ability to successfully achieve benefits from its leadership transition plan, including managing the search for and transition to a new chief executive officer, (ii) AMAG's ability to successfully divest Intrarosa and Vyleesi and the effect and amount of associated expense reductions; (iii) AMAG's ability to drive continued Feraheme growth sufficient to support AMAG's development programs, (iv) AMAG's ability to ensure continued patient access to Makena and that Makena is cash flow positive in 2020, (v) AMAG's pipeline, including AMAG-423 and ciraparantag, (vi) AMAG's ability to successfully out-license its products or product candidates in ex-U.S. territories and (vii) AMAG's ability to meet or exceed its 2020 financial guidance; 2020 financial guidance, including total revenue, operating income and positive adjusted EBITDA, and the related assumptions used to determine the guidance ranges, including various potential regulatory outcomes for Makena and the treatment of Vyleesi and Intrarosa as discontinued operations; and plans to report final, audited 2019 financial results in late February or early March 2020;  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 risk that AMAG will be unable to successfully divest Intrarosa and Vyleesi or that the effect and amount of expense reductions associated with the planned divestments will be less than anticipated, or that cash expenditures will be greater than anticipated; the risk that the FDA will recommend that Makena be removed from the market, particularly in light of the recommendation of the Advisory Committee of the FDA; the risk that, even if the FDA does not recommend that Makena be removed from the market, sales of Makena will continue to be negatively impacted, including as a result of the recommendation of the Advisory Committee; the risk that AMAG will be unable to successfully achieve the anticipated benefits from its leadership transition plan; the possibility that AMAG will encounter challenges retaining or attracting talent; the risk that AMAG may be unable to gain approval of its product candidates, including AMAG-423 and ciraparantag, on a timely basis, or at all; the potential for such approvals, if obtained, to include unanticipated restrictions or warnings; the risk that the costs and time investments for AMAG's development efforts will be higher than anticipated; the possibility that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including AMAG-423 and ciraparantag; the risk that Feraheme and Makena will not achieve the level of revenues needed to support AMAG's development efforts, including because (i) such efforts require greater costs than anticipated, (ii) because approval of any such products is withdrawn, (iii) the FDA takes other adverse action with respect to any such products or (iv) Sandoz Inc. launches a generic version of Feraheme in accordance with the 2018 settlement agreement we entered into with Sandoz; the risk that AMAG will be unable to successfully identify and enter into partnerships with out-licensees for its product candidates in ex-U.S. territories, which could delay the commercialization of those product candidates in certain geographies; the risk that AMAG will not be able to continue to execute on its business plan; the speculative nature of AMAG's estimates as to market share for its products and potential market share for its product candidates and the risk that such estimates are inaccurate; and those 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, 2018, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019 and 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.

    AMAG Pharmaceuticals®, Feraheme® and Vyleesi® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc.

    -Tables Follow-



    Reconciliation of GAAP to Non-GAAP Preliminary Financial Results  
    ($M) Q4-2019
    Preliminary
    Q4-2018
    Actual
    FY 2019
    Preliminary
    FY 2018
    Actual
    GAAP operating loss ($22) - ($12 ) ($18.8 ) ($274) - ($264 )
    ($47.0 )
    Depreciation and intangible asset amortization 7.0   14.0   21.0   160.0  
    Non-cash inventory step-up adjustments --   0.1   --   3.7  
    Stock-based compensation 5.0   5.3   18.5   19.9  
    Adjustments to contingent consideration --   (0.4 ) --   (49.6 )
    Restructuring --   --   7.4   --  
    Transaction/acquisition-related costs --   1.3   0.3   1.3  
    Acquired IPR&D --   --   74.9   32.5  
    Asset impairment charges --   --   82.2   --  
    Non-GAAP adjusted EBITDA ($10) - $0   $1.5   ($70) – ($60 ) 120.8  


    Reconciliation of GAAP to non-GAAP 2020 Financial Guidance ($M)  
    GAAP operating income $2 - $32
    Depreciation 2
    Stock-based compensation 16
    Non-GAAP adjusted EBITDA $20 - $50

    AMAG CONTACTS:
    Investors:
    Linda Lennox
    908-627-3424

    Media:
    Rushmie Nofsinger
    781-530-6838


    1 Includes the recognition of $16M of collaboration revenue due to the termination and settlement agreement entered into with Daiichi Sankyo, Inc. (DSI) in December 2019 related to a clinical trial collaboration agreement that AMAG acquired as part of the Perosphere acquisition. As part of the settlement, AMAG received $10M in cash from DSI in December 2019. 

    2 Operating loss does not include the impact of material impairment charges or the associated acceleration of amortization, which are likely to be recognized in the 2019 audited financial statements.

    3 See reconciliation of GAAP to non-GAAP preliminary financial results at the conclusion of this press release.

    4 See reconciliations of 2020 GAAP to non-GAAP financial guidance at the conclusion of this press release. 2020 financial guidance reflects management's current assumptions about the potential impact of multiple scenarios across our product portfolio, including (i) various potential regulatory outcomes related to Makena and (ii) that the divestitures of Intrarosa and Vyleesi will be reported in discontinued operations for accounting purposes in 2020. Therefore, 2020 financial guidance excludes revenue and expenses related to Intrarosa and Vyleesi.

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  29. WALTHAM, Mass., Jan. 03, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that management will present at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 9:30 a.m. Pacific Time (12:30 p.m. Eastern Time), in San Francisco, California.

    To access the live webcast of the presentation and following breakout session please visit the Investors section of the AMAG website at www.amagpharma.com.  A replay of the presentation will be archived on the AMAG website until February 17, 2020.

    About AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to…

    WALTHAM, Mass., Jan. 03, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that management will present at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 9:30 a.m. Pacific Time (12:30 p.m. Eastern Time), in San Francisco, California.

    To access the live webcast of the presentation and following breakout session please visit the Investors section of the AMAG website at www.amagpharma.com.  A replay of the presentation will be archived on the AMAG website until February 17, 2020.

    About AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women's health. For additional company information, please visit www.amagpharma.com.

    AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc.

    AMAG Pharmaceuticals Contact:
    Loraine Spreen
    617-866-0303

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  30. WALTHAM, Mass., Dec. 18, 2019 (GLOBE NEWSWIRE) -- As part of the company's ongoing support of research to reduce preterm birth and preeclampsia and associated complications, AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced it has awarded four grants totaling nearly $300,000 to independent researchers in the field. 

    "Preterm birth is the leading cause of infant morbidity and mortality, and over the past few years the March of Dimes report card has shown that U.S. preterm birth rates have risen," said Brian Robinson, M.D., senior vice president of medical affairs at AMAG. "Preeclampsia has also been increasing in the U.S and is a major contributor to preterm birth, as well as maternal complications, including mortality.i AMAG is committed…

    WALTHAM, Mass., Dec. 18, 2019 (GLOBE NEWSWIRE) -- As part of the company's ongoing support of research to reduce preterm birth and preeclampsia and associated complications, AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced it has awarded four grants totaling nearly $300,000 to independent researchers in the field. 

    "Preterm birth is the leading cause of infant morbidity and mortality, and over the past few years the March of Dimes report card has shown that U.S. preterm birth rates have risen," said Brian Robinson, M.D., senior vice president of medical affairs at AMAG. "Preeclampsia has also been increasing in the U.S and is a major contributor to preterm birth, as well as maternal complications, including mortality.i AMAG is committed to maternal health and furthering research in this underserved area of medicine."

    The 2019 grant recipients were selected by an independent external review panel of maternal fetal medicine specialists with extensive research experience. The panel was chaired by George Saade, M.D., Professor, Obstetrics/Gynecology and Cell Biology at The University of Texas Medical Branch.

    "I continue to be impressed by the quality of applicants for AMAG's Research Grants Program, which is now in its sixth consecutive year," said Dr. Saade. "With AMAG's contribution, this research will provide clinicians with insights and knowledge to better understand these conditions, which negatively impact pregnancy and necessitate support for additional research."

    The following four investigators and studies have been awarded grants:

    • Jaipal Singh, Ph.D., Director at Indiana Center for Biomedical Innovation at Indiana University School of Medicine and Jennifer Sasser, Ph.D., Associate Professor at the University of Mississippi Medical Center are both researching pharmacological and molecular validation of dimethylarginine dimethylaminohydrolase as a therapeutic target for preeclampsia;
    • Rupsa C. Boelig, M.D., M.S. Assistant Professor Department of Obstetrics and Gynecology, Division of Maternal and Fetal Medicine, Walter K. Kraft, M.D. Professor, Department of Pharmacology and Experimental Therapeutics, Leonard Edelstein, Ph.D. Assistant Professor, Department of Medicine all of Thomas Jefferson University are researching aspirin for prevention of preeclampsia: individual determinants of platelet response and pregnancy outcomes;
    • Jennifer Condon, Ph.D., Associate Professor with Tenure in collaboration with Gil Mor, M.D., Ph.D., Scientific Director, C.S. Mott Center for Human Growth and Development, Vice Chair of Research John M. Malone Jr., M.D. Endowed Professor, Department of Obstetrics and Gynecology Wayne State University School of Medicine both are researching targeting circulating GRP78 as a novel agent to prevent preterm labor;
    • Anum Minhas M.D., Cardiology Fellow, Allison Hays, M.D., Associate Professor of Medicine, Arthur Vaught, M.D., Assistant Professor of Gynecology and Obstetrics and Sammy Zakaria, M.D., MPH, Assistant Professor of Medicine, Division of Cardiology Department of Medicine all of Johns Hopkins Medicine will be researching novel imaging methods to understand the association of preeclampsia and cardiovascular disease.

    About AMAG
    AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women's health. For additional company information, please visit www.amagpharma.com.

    Forward-Looking Statements
    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, beliefs that AMAG's efforts will further research and help doctors to better understand preterm birth or preeclampsia 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, those risks identifi