AMAG AMAG Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Ciraparantag
Anticoagulated reversal agent / Healthy volunteers
|
Phase 2
Phase 2
|
Phase 2b trial planned.
|
|
AMAG-423 / Digoxin immune fab (DIF)
Severe preeclampsia in pregnant women
|
Phase 2/3
Phase 2/3
|
Phase 2/3 enrolment paused due to COVID-19.
|
|
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
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Company initiates CFO & COO succession plan; appoints internal seasoned finance leader as interim CFO
Anthony Casciano assumes expanded role as AMAG's COO
WALTHAM, Mass., June 11, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Edward (Ted) Myles, Chief Financial and Chief Operating Officer, is leaving the Company. Brian Piekos, Senior Vice President of Finance, has been appointed interim Chief Financial Officer and will become a member of the company's Executive Leadership Team. Anthony (Tony) Casciano has been appointed Chief Operating Officer and will add significant operational responsibilities to his role in addition to leading commercial operations. Both appointments are effective immediately.
"Our key priorities are to grow our core business, advance our pipeline and unlock shareholder value," said Scott Myers, AMAG's Chief Executive Officer. "AMAG's succession planning process ensures new leaders can contribute to advance the company. I'm excited to have Brian's experience, capabilities and deep financial acumen brought to the Executive Team, and the Board of Directors and I have full confidence in his leadership. Broadening Tony's role to include additional responsibilities will have a positive impact on AMAG's business and I look forward to partnering with him on refining our business practices and unlocking value. We appreciate the succession plan Ted has put into place and wish him well in his future endeavors."
Mr. Piekos joined AMAG in 2015 and has held a number of senior management positions with the Company. In his most recent role as Senior Vice President of Finance, Mr. Piekos has provided oversight of AMAG's financial planning and reporting, tax, treasury and strategic sourcing processes. He has more than 20 years of corporate finance experience including strategic planning, financial reporting and capital market activities. Prior to AMAG, he held positions of increasing responsibility at Cubist Pharmaceuticals. Mr. Piekos began his career in investment banking having served as Vice President at Leerink Partners and as an analyst at Needham & Company.
Mr. Casciano brings more than 20 years of commercial experience within the pharmaceutical industry. He joined AMAG in September 2016 and has since held positions of increasing responsibility with the Company. In his role as Chief Operating Officer, he will continue overseeing commercial activities, as well as technical operations, global supply chain and information technology for the Company. Prior to AMAG, Mr. Casciano spent 16 years career at Sanofi, where he held multiple commercial leadership roles across a range of departments and therapeutic areas.
ABOUT AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.Forward Looking Statements
This press release contains forward-looking information about AMAG within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding expectations with respect to the leadership changes and the impact on AMAG's business, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.Such risks and uncertainties include, among others, risks and uncertainties related to recent leadership changes, including potential disruption to the business and to management caused by leadership changes and succession efforts, and the potential impact on AMAG's ability to retain and hire talents, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 2020, and in any subsequent filings with the SEC, which are available at the SEC's website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG's results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG's stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward‐looking statements.
AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc.
AMAG CONTACTS
Investors & Media:
Rushmie Nofsinger
(781) 530-6838
-
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Transaction allows AMAG to advance its strategic focus on Feraheme, Makena and its pipeline, consistent with previously announced plans
Millicent Pharma uniquely positioned to drive revenue growth of Intrarosa
WALTHAM, Mass., May 21, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced it has completed the sale of its rights to Intrarosa® (prasterone) to Millicent Pharma Limited, a global pharmaceutical company formed by the Millicent Pharma management team and The Carlyle Group in 2018 that specializes in women's health and menopause-related conditions, for up to $125 million, including upfront fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million.
"As mentioned in our first quarter earnings release, the sale of Intrarosa is an important step in our strategic evolution," said Scott Myers AMAG's president and chief executive officer. "We were impressed with Millicent's commercial capabilities and dedication to women's healthcare and we are pleased to transition this important therapy into their portfolio. We remain focused on maximizing Feraheme's value, maintaining patient access to Makena and developing innovative therapies, while managing expenses to help further our goal of achieving profitability in 2020."
In addition to the upfront consideration of $20 million, AMAG will be entitled to certain sales milestone payments, which include $25 million the first time Intrarosa net sales exceed $65 million during any consecutive 12-month period, a second sales milestone payment of $35 million the first time Intrarosa net sales exceed $115 million during any consecutive 12-month period, and a third milestone payment of $45 million the first time Intrarosa net sales exceed $175 million during any consecutive 12-month period.
The sale of Intrarosa is consistent with AMAG's previously announced strategic decision to divest its women's health assets. AMAG has agreed to provide certain transitional services to Millicent Pharma for a limited period of time while Intrarosa is operationally separated from AMAG. AMAG remains committed to the divestiture of Vyleesi and associated expense reductions as previously announced.
Goldman Sachs & Co. LLC served as exclusive financial advisor and Goodwin Procter LLP served as legal advisor to AMAG in connection with the transaction.
ABOUT AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.Forward Looking Statements
This press release contains forward-looking information about AMAG within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding AMAG's expectations with respect to the sale of its rights to Intrarosa, including the potential consideration payable in connection therewith, Millicent's ability to drive revenue growth of Intrarosa and successfully commercialize Intrarosa, the belief that the sale of Intrarosa is an important step in our strategic evolution, AMAG's plans to focus on maximizing Feraheme's value, maintaining patient access to Makena and developing innovative therapies, and expectations about managing expenses to help further AMAG's goal of achieving profitability in 2020, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.Such risks and uncertainties include, among others, risks and uncertainties related to the sale of AMAG's rights to Intrarosa, including AMAG's ability to satisfy its obligations under the asset purchase and related agreements with Millicent, Millicent's ability to successfully commercialize Intrarosa and satisfy its obligations under the asset purchase and related agreements, AMAG's ability to achieve the expected benefits of the sale of Intrarosa to Millicent, AMAG's efforts to further streamline its business, including to divest Vyleesi and achieve the expected benefits therefrom, including any unintended consequences from such efforts, and AMAG's ability to successfully achieve the expected benefits of such initiatives in a timely manner, or at all, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 2020, and in any subsequent filings with the SEC, which are available at the SEC's website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG's results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG's stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals®, the logo and designs, Feraheme® and Vyleesi® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Any other trademarks referred to in this report are the property of their respective owners.
AMAG CONTACTS:
Investors:
Linda Lennox
908-627-3424Media:
Stacy Nartker
(781) 430-9212 -
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Feraheme® (ferumoxytol injection) posts strong first quarter results
Company implements a workforce reduction of approximately 30 percent or 140 positions,
as part of a planned decrease in operating expensesConference call scheduled for 8:00 a.m. ET today
WALTHAM, Mass., May 11, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the first quarter ended March 31, 2020. The company reported total revenues for the first quarter of 2020 of $68.7 million, including revenue of $44.4 million from Feraheme and revenue of $21.8 million from Makena® (hydroxyprogesterone caproate injection), as well as expense reductions across the business. The company also reported an operating loss of $19.6 million and an adjusted EBITDA loss of $5.5 million in the first quarter of 2020.1
Despite strong first quarter results, AMAG's products are being impacted by the COVID-19 pandemic as patient visits have declined during this period. Given the planned divestiture of Intrarosa® (prasterone) and Vyleesi® (bremelanotide injection) and the impact of COVID-19, AMAG has implemented a company-wide restructuring, which will reduce the workforce by approximately 30 percent. AMAG is withdrawing its 2020 financial guidance due to the uncertainty surrounding the duration of the COVID-19 pandemic.
"We are sharpening our focus on our priorities of maximizing Feraheme's value, retaining patient access to Makena and continuing to efficiently develop innovative therapies, namely ciraparantag," said Scott Myers, AMAG's president and chief executive officer. "As we look to the future, it is difficult to estimate the severity and duration of the COVID-19 pandemic. We've seen signs of stabilization and remain confident in the underlying demand for our products; however, we cannot speculate on the subsequent speed of recovery and the overall impact on our business."
"Based upon the extraordinary dynamics across the industry due to the COVID-19 pandemic, we have decided to withdraw our 2020 financial guidance," said Ted Myles, AMAG's chief financial officer and chief operating officer. "We remain committed to our previously stated goal of reducing total operating expenses by more than $100 million in 2020, as compared to 2019, and we are on track to achieve this objective. Furthermore, we continue to strive towards returning to profitability this year. The work force reduction that we announced today is an important step towards achieving these corporate objectives. While it was a difficult decision, we believe the organization is now the right size to support our long-term goals. We'd like to thank our colleagues who are leaving AMAG for their many contributions to our organization."
OTHER KEY UPDATES
Leadership Transition: AMAG announced in April that its Board of Directors appointed Scott Myers as AMAG's president and chief executive officer, and a member of the Board, effective immediately. Mr. Myers is a proven executive who brings nearly three decades of global pharmaceutical and medical technology experience to AMAG. Mr. Myers succeeds William Heiden who stepped down upon Mr. Myers' appointment.Supply Chain: At this time, all of the company's products remain available and the supply chain has not been materially affected by COVID-19. AMAG continues to closely monitor suppliers and supply levels. The company has risk mitigation plans in place to minimize potential supply interruptions, including redundant drug substance manufacturing and inventory safety stock, and will continue to work diligently with its suppliers to maintain continuous supply as the COVID-19 situation continues to evolve.
Regulatory: In response to the company's request to the FDA for a meeting to discuss the future of Makena, the FDA indicated that it was premature to meet at this time as it was still reviewing the matter. AMAG remains committed to working collaboratively with the FDA to maintain access to Makena for eligible pregnant women.
Clinical Trials: The COVID-19 pandemic is an evolving situation and is having a serious impact on clinical trials globally. The AMAG-423 Phase 2b/3a clinical trial is a hospital-based trial and all sites have paused new patient enrollment. The company has had to pause initiation of new sites due to the pandemic, significantly impacting recruitment and enrollment. AMAG continues to work with the FDA to initiate the ciraparantag Phase 2b trial in healthy volunteers in the U.S. However, the COVID-19 pandemic has forced the clinical trial sites where the company expected to conduct the trial to close.
FIRST QUARTER ENDED MARCH 31
Revenue
First quarter revenue totaled $68.7 million, compared to $75.8 million for the same period in 2019. This decrease was primarily due to a decrease in sales of Makena stemming from the unfavorable FDA Advisory Committee recommendation for Makena in October 2019. These decreases were partially offset by an increase in sales of Feraheme.- Feraheme achieved first quarter revenue of $44.4 million, an increase of 11 percent over the same period last year. Feraheme's average quarterly market share was 17.2 percent in the first quarter of 2020, compared to 16.2 percent in the first quarter of 2019.
- Makena first quarter revenue totaled $21.8 million, compared to $31.3 million in the first quarter of last year.
- Intrarosa revenue in the first quarter of 2020 totaled $3.2 million, compared to $4.4 million in the same period last year.
($M) Three Months Ended March 31, 2020 2019 Total revenues $68.7 $75.8 Feraheme 44.4 40.0 Makena 21.8 31.3 Intrarosa 3.2 4.4 Other (0.7 ) 0.1 Operating Expenses
Total costs and expenses decreased by $105.3 million to $88.2 million in the first quarter of 2020, as compared to the first quarter of 2019. In the first quarter of last year, the company recorded $74.9 million of acquired in-process research and development (IPR&D) expense in connection with the acquisition of Perosphere Pharmaceuticals for the development asset, ciraparantag. Also recorded in the first quarter of last year was a one-time restructuring charge of $7.4 million related to combining the company's maternal health and women's health sales forces in February 2019.- Cost of products sales in the first quarter of 2020 increased by $5.9 million, as compared with the first quarter of last year, driven by an increase in amortization expense associated with the Makena, Intrarosa and Vyleesi intangible assets.
- Research and development (R&D) expenses totaled $11.2 million, compared to $18.1 million in the first quarter of last year. This decrease was primarily related to lower costs for Vyleesi following its FDA approval in June 2019.
- Selling, general and administrative (SG&A) expenses decreased by approximately $22.0 million, or 29 percent, in the first quarter of 2020, compared to the same period in 2019.
($M) Three Months Ended March 31, 2020 2019 Amortization of intangible assets $9.8 $3.9 Direct cost of product sales 14.5 14.5 Total cost of product sales 24.3 18.4 Research and development expenses 11.2 18.1 Acquired in-process research and development — 74.9 Selling, general and administrative expenses 52.7 74.7 Restructuring expenses — 7.4 Total costs and expenses $88.2 $193.5 Balance Sheet
- As of March 31, 2020, the company's cash and investments totaled $124.7 million.
- Long-term debt totaled $320.0 million (representing the principal amounts outstanding of the 2022 convertible notes).
Operating Loss and Adjusted EBITDA
- The company reported an operating loss of $19.6 million in the first quarter of 2020, compared to an operating loss of $117.7 million in the same period last year.
- The company reported a loss in adjusted EBITDA of $5.5 million in the first quarter of 2020, compared to a loss in adjusted EBITDA of $26.6 million in the same period last year.
($M) Three Months Ended March 31, 2020 2019 Operating loss $(19.6 ) $(117.7 ) Non-GAAP adjusted EBITDA1 $(5.5 ) $(26.6 ) 1 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release.
CONFERENCE CALL AND WEBCAST ACCESS
AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company's first quarter 2020 financial results and recent business updates.DIAL-IN NUMBERS
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 4948155Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4948155A telephone replay will be available from approximately 11:00 a.m. ET on May 11, 2020 through midnight on May 18, 2020.
The webcast with slides will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.
USE OF NON-GAAP FINANCIAL MEASURES
AMAG has presented certain non-GAAP financial measures, including non-GAAP costs and expenses, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization) and non-GAAP diluted shares outstanding. These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG's GAAP financial statements, because it provides greater transparency regarding AMAG's operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG's operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.ABOUT AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.FORWARD-LOOKING STATEMENTS
This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding AMAG's planned divestiture of Intrarosa and Vyleesi, expected results of and benefits from the workforce reduction, beliefs that AMAG can maximize Feraheme's value or retain patient access to Makena, expectations regarding the impact of the COVID-19 pandemic on AMAG's business, including signs of stabilization, beliefs about the demand for AMAG's products, plans to reduce total operating expenses by more than $100 million in 2020 and the belief that AMAG is on track to achieve that goal, beliefs that AMAG can undertake efforts to achieve profitability for 2020, beliefs that AMAG is now the right size to support long-term goals, statements related to the COVID-19 pandemic and its general impact, potential severity, duration and spread, beliefs that AMAG's risk mitigation plans will minimize potential supply interruptions due to the COVID-19 pandemic, beliefs that AMAG will be able to work collaboratively with the FDA to enable continued patient access to Makena, plans to work with the FDA to initiate the ciraparantag Phase 2b trial and estimates for Feraheme's market share are based on management's current expectations and beliefs and are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.Such risks and uncertainties include, among others, risks and uncertainties related to the scale and scope of the COVID-19 pandemic and its impact on AMAG's revenues and operations, including clinical trials, as well as COVID-19's impact on AMAG's business partners, healthcare providers, patients, employees and the health care industry and worldwide economies generally, risks related to efforts to streamline the business, including the workforce reduction and the planned divestiture of Intrarosa and Vyleesi, including any unintended consequences from such efforts and AMAG's ability to successfully achieve the expected benefits of such initiatives in a timely manner, or at all, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 2020, and in any subsequent filings with the SEC , which are available at the SEC's website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG's results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG's stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals®, the logo and designs, Feraheme® and Vyleesi® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Any other trademarks referred to in this report are the property of their respective owners.
- Tables Follow -
AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited, amounts in thousands, except for per share data)Three Months Ended March 31, 2020 2019 Revenues: Feraheme $ 44,433 $ 40,015 Makena 21,777 31,257 Intrarosa 3,169 4,414 Other (751 ) 43 Total product revenues 68,628 75,729 Other revenues 33 75 Total revenues 68,661 75,804 Operating costs and expenses: Cost of product sales 24,359 18,477 Research and development expenses 11,180 18,066 Acquired in-process research and development — 74,856 Selling, general and administrative expenses 52,697 74,682 Restructuring expenses — 7,420 Total costs and expenses 88,236 193,501 Operating loss (19,575 ) (117,697 ) Other income (expense): Interest expense (6,604 ) (6,450 ) Interest and dividend income 477 1,586 Other income 1,311 340 Total other expense, net (4,816 ) (4,524 ) Loss before income taxes (24,391 ) (122,221 ) Income tax expense (benefit) 100 (137 ) Net loss $ (24,491 ) $ (122,084 ) Basic and diluted net loss per share $ (0.72 ) $ (3.54 ) Weighted average shares outstanding used to compute net loss per share (basic and diluted) 34,104 34,469 AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, amounts in thousands)March 31, 2020 December 31, 2019 ASSETS Current assets: Cash and cash equivalents $ 54,455 $ 113,009 Marketable securities 70,288 58,742 Accounts receivable, net 106,484 94,163 Inventories 33,676 31,553 Prepaid and other current assets 25,734 19,100 Total current assets 290,637 316,567 Property and equipment, net 3,312 4,116 Goodwill 422,513 422,513 Intangible assets, net 13,783 23,620 Operating lease right-of-use asset 22,835 23,286 Deferred tax assets — 630 Restricted cash 495 495 Total assets $ 753,575 $ 791,227 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 16,520 $ 27,021 Accrued expenses 167,661 177,079 Current portion of operating lease liability 4,065 4,077 Current portion of acquisition-related contingent consideration — 17 Total current liabilities 188,246 208,194 Long-term liabilities: Convertible notes, net 281,038 277,034 Long-term operating lease liability 19,433 19,791 Other long-term liabilities 1,120 89 Total liabilities 489,837 505,108 Commitments and contingencies Stockholders' equity: Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued — — Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,266,256
and 33,999,081 shares issued and outstanding at March 31, 2020 and December 31,
2019, respectively342 339 Additional paid-in capital 1,300,572 1,297,917 Accumulated other comprehensive loss (3,787 ) (3,239 ) Accumulated deficit (1,033,389 ) (1,008,898 ) Total stockholders' equity 263,738 286,119 Total liabilities and stockholders' equity $ 753,575 $ 791,227 AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)Three Months Ended March 31, 2020 2019 Cash flows from operating activities: Net loss $ (24,491 ) $ (122,084 ) Adjustments to reconcile net loss to net cash (used in) provided by operating activities: Depreciation and amortization 10,318 4,375 Provision for bad debt expense 223 (16 ) Amortization of premium/discount on purchased securities 4 (27 ) Write-down of inventory 616 — Non-cash equity-based compensation expense 3,868 4,873 Non-cash IPR&D expense — 18,029 Amortization of debt discount and debt issuance costs 4,004 3,783 Gains on marketable securities, net (9 ) — Change in fair value of contingent consideration — (6 ) Deferred income taxes 630 458 Non-cash lease expense 451 — Gain on sale of assets (1,409 ) — Changes in operating assets and liabilities: Accounts receivable, net (12,547 ) (7,971 ) Inventories (2,770 ) (2,973 ) Prepaid and other current assets (6,490 ) (21,580 ) Accounts payable and accrued expenses (19,671 ) 31,432 Other assets and liabilities 664 1,799 Net cash used in operating activities (46,609 ) (89,908 ) Cash flows from investing activities: Proceeds from sales or maturities of marketable securities 11,255 27,945 Purchase of marketable securities (23,345 ) (14,815 ) Net proceeds from the sale of assets 1,440 — Capital expenditures (68 ) (1,794 ) Net cash (used in) provided by investing activities (10,718 ) 11,336 Cash flows from financing activities: Payments to settle convertible notes — (21,417 ) Payments of contingent consideration (17 ) (17 ) Payments for repurchases of common stock — (13,730 ) Proceeds from the exercise of common stock options — 33 Payments of employee tax withholding related to equity-based compensation (1,210 ) (1,636 ) Net cash used in financing activities (1,227 ) (36,767 ) Net decrease in cash, cash equivalents, and restricted cash (58,554 ) (115,339 ) Cash, cash equivalents, and restricted cash at beginning of the period 113,504 253,751 Cash, cash equivalents, and restricted cash at end of the period $ 54,950 $ 138,412 Supplemental data for cash flow information: Cash (refunded) paid for taxes $ (256 ) $ 78 Cash paid for interest $ — $ 267 Non-cash investing and financing activities: Settlement of note receivable in connection with Perosphere acquisition $ — $ 10,000 Right-of-use assets obtained in exchange for lease liabilities $ — $ 918 AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended March 31, 2020
(Unaudited, amounts in thousands)Revenue Cost of product
salesResearch &
developmentSelling, general &
administrativeOperating Loss /
Adjusted EBITDAGAAP $ 68,661 $ 24,359 $ 11,180 $ 52,697 $ (19,575 ) Depreciation and intangible asset amortization — (9,837 ) (76 ) (405 ) Stock-based compensation — (203 ) (70 ) (3,512 ) Non-GAAP Adjusted $ 68,661 $ 14,319 $ 11,034 $ 48,780 $ (5,472 ) AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended March 31, 2019
(Unaudited, amounts in thousands)Revenue Cost of product sales Research & development Selling, general & administrative Acquired
IPR&DRestructuring Operating Loss / Adjusted EBITDA GAAP $ 75,804 $ 18,477 $ 18,066 $ 74,682 $ 74,856 $ 7,420 $ (117,697 ) Depreciation and intangible asset amortization — (3,943 ) (8 ) (424 ) — — Stock-based compensation — (202 ) (680 ) (3,325 ) — — Acquisition-related costs — — — (270 ) — — Restructuring — — — — — (7,420 ) Acquired IPR&D — — — — (74,856 ) — Non-GAAP Adjusted $ 75,804 $ 14,332 $ 17,378 $ 70,663 $ — $ — $ (26,569 ) AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(Unaudited, amounts in millions)Three Months Ended March 31, 2020 2019 Weighted avg. basic and diluted shares outstanding 34.1 34.5 Employee equity incentive awards 0.2 2 0.2 3 Non-GAAP diluted shares outstanding 34.3 34.7 2 Employee equity incentive awards would be anti-dilutive in this period.
3 Reflects the non-GAAP dilutive impact of employee equity incentive awards.CONTACT:
Linda Lennox
908-627-3424 -
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WALTHAM, Mass., April 28, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its Board of Directors has appointed Scott Myers as AMAG's President and Chief Executive Officer, and member of the Board, effective immediately. Mr. Myers succeeds William Heiden, who is stepping down from such roles in light of Mr. Myers' appointment.
"Scott is a seasoned leader with exceptional experience, skill set and passion, and it became evident to the Board through its rigorous search that Scott is the ideal candidate to lead AMAG forward," said Gino Santini, Chairman of AMAG's Board. "Scott's track record of success, coupled with his experience leading companies with development stage and commercialized assets, uniquely positions him to lead the Company. The Board is confident that Scott will maximize AMAG's strengths and proven capabilities and enable the Company to better serve patients."
Mr. Santini added, "The Board of Directors would like to thank Bill for his dedication and leadership over the past eight years. We appreciate Bill's contributions to AMAG and we wish him the best in his future endeavors."
Mr. Myers is a proven executive who brings nearly three decades of global pharmaceutical and medical technology experience to AMAG. Mr. Myers most recently served as Chairman and Chief Executive Officer of Rainier Therapeutics, a clinical-stage biotechnology company focused on metastatic bladder cancer. Prior to joining Rainier, Mr. Myers served as Chief Executive Officer, President and as a director of Cascadian Therapeutics Inc. Mr. Myers also served as Chief Executive Officer of Aerocrine AB, a medical device company from 2011 to 2015. While at the helm of these companies, Mr. Myers drove transformation that maximized growth and delivered significant long-term value.
"AMAG is at a pivotal point in its evolution and I look forward to working with AMAG's Board, its leadership team and its dedicated employees to advance the strategic plan, further define the Company's future, optimize its current products and bring innovative therapies to patients in need," said Mr. Myers. "We have a significant opportunity ahead of us to unlock the potential of AMAG's pipeline and leverage its existing commercial strengths to drive long-term growth and shareholder value."
Mr. Myers is currently an independent director of Selecta Biosciences where he serves as the Chair of the Compensation and Benefits Committee, as well as a member of the Nominating and Governance Committee. Mr. Myers also serves as an independent director for Harpoon Therapeutics, a clinical stage biotechnology company where he serves on the Audit Committee. Mr. Myers began his career in management consulting and then moved into the pharmaceutical industry through senior leadership roles at Johnson & Johnson, DOV Pharmaceuticals and UCB.
Mr. Myers holds a Bachelor of Arts in Biology from Northwestern University in Evanston, Illinois, and a Master of Business Administration from The University of Chicago Graduate School of Business (Booth) in Chicago, Illinois.
Inducement Equity Awards
The Board of Directors of AMAG approved an inducement award to Mr. Myers of an option to purchase 1,000,000 shares of common stock. The option will have an exercise price equal to the closing price of AMAG's common stock on the grant date and will be exercisable in four equal annual installments beginning on the first anniversary of April 28,2020 (the grant date). The option will have a ten-year term and be subject to the terms and conditions of the stock option agreement pursuant to which the option will be granted. This equity award will be granted without stockholder approval as inducements material to the employee entering into employment with AMAG in accordance with NASDAQ Listing Rule 5635(c)(4).ABOUT AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.FORWARD-LOOKING STATEMENTS
This press release contains forward-looking information about AMAG within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, expectations of the Board of Directors that Mr. Myers' experience and skills will maximize the value of AMAG's strengths and capabilities and enable the Company to better serve patients; AMAG's expectations for the leadership transition, including expectations and beliefs regarding AMAG's ability to successfully achieve benefits from the appointment of Mr. Meyers as President and Chief Executive Officer; and Mr. Myers' expectations that AMAG will advance its strategic plan, optimize its current products and bring innovative therapies to patients and unlock the potential of AMAG's pipeline and leverage its existing commercial strengths to drive long-term growth and shareholder value are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.Such risks and uncertainties include, among others, the risk that AMAG will be unable to successfully achieve the anticipated benefits from the appointment of Mr. Myers are Chief Executive Officer and President, as well as those risks identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, and subsequent filings with the SEC, which are available at the SEC's website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG's results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG's stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward‐looking statements.
AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc.
AMAG CONTACTS:
Investors:
Linda Lennox
908-627-3424Media:
Sarah Connors
781-296-0722 -
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WALTHAM, Mass., April 27, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its first quarter 2020 financial results will be released on Monday, May 11, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.
Dial-in Number
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 4948155Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4948155A telephone replay will be available from approximately 11:00 a.m. ET on May 11, 2020 through midnight on May 18, 2020.
The webcast with slides will be accessible through the Investors section of the company's website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.
About AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals Contact:
Loraine Spreen
617-866-0303