 Financial guidance reissued to include EBITDA-positive projection for second-half 2020 Strategic shift and momentum build through recent business development activitiesBrian Piekos promoted to Chief Financial OfficerConference call scheduled for 8:00 a.m. ET todayWALTHAM, 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 2020.1Amidst the unprecedented uncertainty that COVID-19 placed on the healthcare system and our economy, AMAGs 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, AMAGs Chief Executive Officer. Over the past three months, we have advanced the companys strategic evolution by reaching important milestones that include a strategic, ex-US partnership with Norgine to further progress ciraparantag and strengthen our companys 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 GUIDANCEM 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 AMAGs 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 2b3a 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 2b3a 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 DSMBs 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. Ferahemes 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. Makenas average quarterly market share was 66 percent in the second quarter of 2020, compared to 63 percent in the second quarter of 2019.MThree Months Ended June 30, 2020 2019 Total revenues52.8 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 RD 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 SGA 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 womens health assets and reduced compensation-related costs as a result of the May 2020 restructuring.MThree Months Ended June 30, 2020 2019 Amortization of intangible assets9.0 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 expenses59.8 194.0 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.MThree Months Ended June 30, 2020 2019 Operating loss7.0116.2 Non-GAAP adjusted EBITDA51.724.7 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. 