AMAG AMAG Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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AMAG-423 / Digoxin immune fab (DIF)
Severe preeclampsia in pregnant women
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Phase 2/3
Phase 2/3
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Phase 2/3 trial stopped due to low likelihood of efficacy - August 6, 2020.
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Ciraparantag
Anticoagulated reversal agent / Healthy volunteers
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Phase 2
Phase 2
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Phase 2b trial planned.
|
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Makena
Preterm birth
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Phase 3
Phase 3
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Advisory Committee voted 9-7 recommending withdrawal from market - October 29, 2019.
|
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Feraheme
Adults with iron deficiency anemia (IDA)
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Approved
Approved
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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
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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
-
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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: 4548238Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4548238A 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 Makena 22,325 30,593 45,888 61,534 Intrarosa 1,216 4,877 4,385 9,291 Other (447 ) 90 (1,199 ) 133 Total product revenues 52,729 77,634 123,142 153,047 Other revenues 26 133 58 208 Total revenues 52,755 77,767 123,200 153,255 Operating costs and expenses: Cost of product sales 18,180 24,290 42,539 42,767 Research and development expenses 8,263 14,980 19,443 33,046 Acquired in-process research and development — — — 74,856 Selling, general and administrative expenses 39,568 77,324 92,266 152,006 Impairment of intangible assets — 77,358 — 77,358 Gain on sale of assets (14,444 ) — (14,444 ) — Restructuring expenses 8,197 — 8,197 7,420 Total costs and expenses 59,764 193,952 148,001 387,453 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 income 327 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 securities 48,594 58,742 Accounts receivable, net 65,104 94,163 Inventories 30,388 31,553 Prepaid and other current assets 20,950 19,100 Total current assets 263,557 316,567 Property and equipment, net 3,031 4,116 Goodwill 422,513 422,513 Intangible assets, net 3,946 23,620 Operating lease right-of-use asset 22,007 23,286 Deferred tax assets — 630 Restricted cash 495 495 Total assets $ 715,549 $ 791,227 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 12,944 $ 27,021 Accrued expenses 144,567 183,382 Current portion of operating lease liability 3,488 4,077 Current portion of acquisition-related contingent consideration — 17 Total current liabilities 160,999 214,497 Long-term liabilities: Convertible notes, net 285,137 277,034 Long-term operating lease liability 19,263 19,791 Other long-term liabilities 828 89 Total liabilities 466,227 511,411 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, respectively 344 339 Additional paid-in capital 1,303,095 1,297,917 Accumulated other comprehensive loss (2,964 ) (3,239 ) Accumulated deficit (1,051,153 ) (1,015,201 ) Total stockholders' equity 249,322 279,816 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 amortization 19,791 9,089 Impairment of intangible assets — 77,358 Provision for bad debt expense 230 (12 ) Amortization of premium/discount on purchased securities 42 (51 ) Write-down of inventory 616 4,836 (Gain)/loss on disposal of property & equipment 230 — Non-cash equity-based compensation expense 5,879 9,407 Non-cash IPR&D expense — 18,029 Amortization of debt discount and debt issuance costs 8,103 7,513 Gains on marketable securities, net (10 ) (270 ) Change in fair value of contingent consideration — (21 ) Deferred income taxes 630 630 Non-cash lease expense 1,279 — Gain on sale of assets (15,853 ) — Changes in operating assets and liabilities: Accounts receivable, net 28,828 (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 securities 33,735 46,420 Purchase of marketable securities (23,345 ) (14,815 ) Net proceeds from the sale of assets 19,344 — Capital expenditures (790 ) (1,907 ) Net cash provided by investing activities 28,944 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 ESPP 631 851 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 period 113,504 253,751 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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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: 4548238Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4548238A 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 -
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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) 530-6838Investors:
Loraine Spreen
617-866-0303 -
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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) 530-6838Media:
Stacy Nartker
(781) 430-9212Norgine Contacts:
Clara Bentham +44 (0)1895 826654 or +44 (0)7734 367883
Eleni Fistikaki +44 (0)1895826227 or +44 (0)7825 389477[email protected]
www.norgine.com
Follow us @norgine1 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