AMAG AMAG Pharmaceuticals Inc.

9.4
+0.13  (+1%)
Previous Close 9.27
Open 9.28
52 Week Low 4.41
52 Week High 13.53
Market Cap $324,108,672
Shares 34,479,646
Float 16,518,092
Enterprise Value $479,020,132
Volume 834,892
Av. Daily Volume 452,440
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Drug Pipeline

Drug Stage Notes
AMAG-423 / Digoxin immune fab (DIF)
Severe preeclampsia in pregnant women
Phase 2/3
Phase 2/3
Phase 2/3 trial stopped due to low likelihood of efficacy - August 6, 2020.
Ciraparantag
Anticoagulated reversal agent / Healthy volunteers
Phase 2
Phase 2
Phase 2b trial planned.
Makena
Preterm birth
Phase 3
Phase 3
Advisory Committee voted 9-7 recommending withdrawal from market - October 29, 2019.
Feraheme
Adults with iron deficiency anemia (IDA)
Approved
Approved
Approval for sNDA filing announced February 5, 2018.
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
Approved
Approved
FDA approval announced June 21, 2019.
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
Approved
Approved
Approval announced February 14, 2018.

Latest News

  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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