UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): February 9, 2015
AMAG PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
001-10865 |
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04-2742593 |
(Commission File Number) |
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(IRS Employer Identification No.) |
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1100 Winter Street |
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Waltham, Massachusetts |
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02451 |
(Address of principal executive offices) |
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(Zip Code) |
(617) 498-3300
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
The following information and Exhibits 99.1 and 99.2 attached hereto shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it or they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
On February 9, 2015, AMAG Pharmaceuticals, Inc. (the Company) issued a press release regarding its operating results and revenues for the quarter and year ended December 31, 2014 and its intention to hold a conference call to discuss the Companys financial results and provide a business update, including as to regulatory status and growth prospects. A copy of the Companys press release is furnished herewith as Exhibit 99.1 and a copy of the presentation slides to be used during the conference call are furnished herewith as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The Company hereby furnishes the following exhibits:
Exhibit |
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Description |
99.1 |
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Press Release dated February 9, 2015. |
99.2 |
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Copy of presentation slides of the Company to accompany the February 9, 2015 conference call. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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AMAG PHARMACEUTICALS, INC. | |
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By: |
/s/ Scott B. Townsend |
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Scott B. Townsend | |
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General Counsel and Senior Vice President of Legal Affairs | |
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Date: February 9, 2015 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
AMAG Announces Final Fourth Quarter and Year End 2014 Financial Results
· Total fourth quarter revenue increased by 145%
· $73 million in pro forma fourth quarter 2014 product sales
· $153 million tax benefit recognized as a result of Lumara Health transaction
Conference call scheduled for 4:30 p.m. ET today
WALTHAM, MA (February 9, 2015) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2014. Total revenues for the fourth quarter in 2014 were 145% greater than revenues for the same period in 2013, driven by increased sales of Feraheme® (ferumoxytol) Injection and the addition of Makena® (hydroxyprogesterone caproate injection) sales following the closing of the acquisition of Lumara Health on November 12, 2014.
In 2014, we successfully achieved key company goals, from strong sales growth of Feraheme, to the consummation of the transformative acquisition of Lumara Health and its flagship product Makena. Strong product revenue growth and additional acquired products are evidence that we are delivering on our commitment to the patients we serve, said William Heiden, president and chief executive officer of AMAG. Were proud of the substantial progress weve made toward becoming a profitable specialty pharmaceutical company and creating significant shareholder value.
Heiden continued, The successes of this past year have given us an even stronger foundation to continue to build across an ambitious new set of goals for 2015, which include driving further product sales growth, achieving meaningful earnings, executing on our lifecycle management plans for Makena and further portfolio diversification through additional business development transactions.
2015 Goals
The companys goals for 2015 include the following:
· Drive significant growth (+50%) of Makena product sales over pro forma sales in 2014 by increasing the number of patients treated with Makena (increase market share) and supporting patients compliance to therapy (increase number of injections per patient);
· Maximize Feraheme product sales by increasing the number of patients on therapy within the current U.S. indication, continuing market expansion initiatives and growing net revenue per gram;
· Drive MuGard® Mucoadhesive Oral Wound Rinse growth across the 400,000 patients in the U.S. at risk of developing oral mucositis, including expanding patient access to the product;
· Complete transition to profitable specialty pharmaceutical company with earnings before interest, taxes, depreciation and amortization (EBITDA) margin on product sales in excess of 50%;
· Continue to execute on our multi-pronged lifecycle management program for Makena, including:
· Receiving a favorable Q2 2015 FDA decision on and subsequent launch of the companys preservative-free, single-dose (1 mL) vial currently under review; and
· Building on the feedback received in the companys January 2015 meeting with the FDA to progress other lifecycle management projects currently underway.
· Determine potential path forward for Feraheme for the broad IDA indication in the U.S. with input from the FDA; and
· Further expand the companys product portfolio through acquisition or in-licensing of specialty pharmaceutical products or companies.
2015 Financial Outlook
In January 2015, the company issued the following financial guidance for 2015:
· Total revenue of between $380 million and $420 million, including:
· Total product sales of between $335 million and $375 million from the following:
· Makena net sales of between $245 million and $270 million;
· Feraheme and MuGard net sales of between $90 million and $105 million; and
· Collaboration revenue of approximately $45 million from the Takeda agreement, which was mutually terminated in December 2014, most of which is non-cash.
· Non-GAAP adjusted EBITDA(1) of between $180 million and $200 million; and
· Non-GAAP cash earnings(1) of between $150 million and $170 million.
Fourth Quarter and Full Year 2014 Financial Results (unaudited)
Total revenues for the quarter ended December 31, 2014 were $53.3 million, a 145% increase compared to $21.7 million for the same period in 2013. Total revenues for 2014 were $124.4 million, a 54% increase compared to $80.9 million for 2013.
Net product sales for the quarter ended December 31, 2014 totaled $46.6 million, including $24.1 million(2) of sales from Feraheme in the U.S. and $22.5 million of sales from Makena, recorded from the closing date of the Lumara Health acquisition (November 12, 2014) through the end of 2014. Net product sales for 2014 totaled $108.8 million. U.S. Feraheme sales totaled $86.3 million(2), which represents a 21% increase compared to the $71.4 million for the same period in 2013, and Makena sales totaled $22.5 million. The strong growth in 2014 Feraheme sales was driven by increases in volume, as well as an increasing net revenue per gram.
Pro forma net product sales for the quarter and year ended December 31, 2014 were $73 million and $252 million, respectively. The pro forma amounts represent total net product sales as if the acquisition of Lumara Health (and Makena) had occurred at the beginning of the period.
Total operating expenses for the quarter ended December 31, 2014 were $44.9 million, compared to $22.4 million for the same period in 2013. Total operating expenses for 2014 were $107.9 million, as compared to $80.5 million for 2013. The increases in operating expenses during the quarter and year ended December 31, 2014 relate primarily to transaction-related expenses in support of the companys
(1) See summary of non-GAAP adjustments related to forward-looking guidance at conclusion of press release
(2) Includes a favorable $1.8 million release of product return reserves
acquisition of Lumara Health and operating expenses associated with Lumara Health since the closing of the acquisition.
The company recognized a non-cash income tax benefit of $153 million in the quarter ended December 31, 2014 associated with the release of reserves on legacy AMAG tax attributes (e.g., net operating losses) as a result of the Lumara Health transaction. The company does not anticipate paying any significant cash taxes in 2015.
The company reported a net income of $143.0 million, or $5.98 per basic share and $4.67 per diluted share, for the quarter ended December 31, 2014, as compared to a net loss of $3.7 million, or $0.17 per basic and diluted share, for the quarter ended December 31, 2013. Net income for 2014 was $135.8 million, or $6.06 per basic share and $5.45 per diluted share, as compared to a net loss of $9.6 million, or $0.44 per basic and diluted share, for 2013.
Non-GAAP adjusted EBITDA(3) for the quarter ended December 31, 2014 was $14.5 million, as compared to negative $2.8 million for the same period in 2013. Non-GAAP adjusted EBITDA for 2014 was $14.3 million, as compared to negative $5.6 million for 2013.
AMAG ended the year with $144.2 million in cash and investments and $540 million in debt.
We are proud of the achievements of 2014, represented in our financial results reported today: significant volume and price growth for Feraheme, the addition of a high-growth commercial product to our portfolio, and continued financial discipline, said Frank Thomas, executive vice president and chief operating officer of AMAG. With the Lumara Health integration substantially complete, we now set our sights on a new set of goals in 2015. The growth in our EBITDA and cash generated by our business will allow us to build financing capacity for additional transactions to leverage our expertise in hematology/oncology and maternal health.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides today at 4:30 p.m. ET, during which management will discuss the companys financial results, regulatory status, and growth prospects. To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 7:00 p.m. ET on February 9, 2015 through midnight on February 16, 2015. To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access. The pass code for the live call and the replay is 80800854.
The call will be webcast with slides and accessible through the Investors section of the companys website at www.amagpharma.com. The webcast replay will be available from approximately 7:00 p.m. ET on February 9, 2015 through midnight March 10, 2015.
(3) See summary of non-GAAP adjustments to reconcile Net Income to Adjusted EBITDA at conclusion of press release
AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited, amounts in thousands, except per share data)
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Three Months Ended |
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Twelve Months Ended |
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2014 |
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2013 |
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2014 |
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2013 |
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Revenues: |
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U.S. product sales, net |
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$ |
46,648 |
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$ |
18,981 |
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$ |
108,795 |
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$ |
71,362 |
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Other product sales and royalties |
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3,143 |
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401 |
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4,703 |
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1,109 |
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License fee and other collaboration revenues |
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3,462 |
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2,329 |
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10,886 |
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8,385 |
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Total revenues |
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53,253 |
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21,711 |
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124,384 |
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80,856 |
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Operating costs and expenses: |
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Cost of product sales |
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11,758 |
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3,326 |
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20,306 |
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11,960 |
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Research and development expenses |
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7,764 |
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6,581 |
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24,160 |
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20,564 |
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Selling, general and administrative expenses |
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27,521 |
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15,799 |
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72,254 |
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59,167 |
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Acquisition related expenses |
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7,561 |
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9,478 |
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782 |
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Restructuring expenses |
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2,023 |
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2,023 |
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Total operating costs and expenses |
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56,627 |
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25,706 |
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128,221 |
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92,473 |
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Operating loss |
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(3,374 |
) |
(3,995 |
) |
(3,837 |
) |
(11,617 |
) | ||||
Interest expense |
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(7,041 |
) |
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(14,697 |
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Interest and dividend income, net |
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166 |
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278 |
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975 |
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1,051 |
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Gains on sale of assets |
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1 |
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59 |
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103 |
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924 |
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Gains (losses) on investments, net |
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97 |
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4 |
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114 |
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40 |
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Net loss before income taxes |
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(10,151 |
) |
(3,654 |
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(17,342 |
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(9,602 |
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Income tax benefit |
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153,159 |
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153,159 |
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Net income (loss) |
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$ |
143,008 |
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$ |
(3,654 |
) |
$ |
135,817 |
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$ |
(9,602 |
) |
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Net income (loss) per basic share |
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$ |
5.98 |
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$ |
(0.17 |
) |
$ |
6.06 |
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$ |
(0.44 |
) |
Net income (loss) per diluted share |
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$ |
4.67 |
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$ |
(0.17 |
) |
$ |
5.45 |
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$ |
(0.44 |
) |
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Weighted average shares outstanding used to compute net income (loss) per share: |
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Basic |
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23,911 |
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21,743 |
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22,416 |
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21,703 |
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Diluted |
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30,992 |
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21,743 |
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25,225 |
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21,703 |
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AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
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December 31, 2014 |
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December 31, 2013 |
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Cash and cash equivalents |
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$ |
119,296 |
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$ |
26,986 |
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Short-term investments |
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24,890 |
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186,803 |
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Accounts receivable, net |
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38,172 |
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6,842 |
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Inventories |
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40,610 |
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17,217 |
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Receivable from collaboration |
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4,518 |
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278 |
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Deferred income taxes |
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32,094 |
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Other current assets |
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14,456 |
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6,279 |
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Total current assets |
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274,036 |
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244,405 |
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Property and equipment, net |
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1,519 |
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1,846 |
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Goodwill |
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205,824 |
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Intangible assets, net |
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887,908 |
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16,844 |
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Other assets |
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19,646 |
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2,364 |
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Total assets |
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$ |
1,388,933 |
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$ |
265,459 |
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|
|
|
|
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Accounts payable |
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$ |
7,301 |
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$ |
2,629 |
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Accrued expenses |
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80,811 |
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22,266 |
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Current portion of long-term debt |
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34,000 |
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Deferred revenues |
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44,376 |
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8,226 |
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Total current liabilities |
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166,488 |
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33,121 |
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Long-term debt, net |
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293,905 |
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Convertible 2.5% senior notes, net |
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167,441 |
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|
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Acquisition-related contingent consideration, net |
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217,984 |
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13,609 |
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Deferred income tax liability |
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77,619 |
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Deferred revenue |
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|
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44,534 |
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Other long-term liabilities |
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5,543 |
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1,787 |
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Total long-term liabilities |
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762,492 |
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59,930 |
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Total stockholders equity |
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459,953 |
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172,408 |
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Total liabilities and stockholders equity |
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$ |
1,388,933 |
|
$ |
265,459 |
|
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on maternal health, anemia and cancer supportive care. The primary goal of AMAG and its maternal health division is to bring to market therapies that provide clear benefits and improve patients lives. In addition to continuing to pursue opportunities to make new advancements in patients health and to enhance treatment accessibility, AMAG intends to continue to expand and diversify its portfolio through the in-license or purchase of additional pharmaceutical products or companies. For additional company information, please visit www.amagpharma.com.
About Makena® (hydroxyprogesterone caproate injection)
Makena® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.
Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
For additional U.S. product information, including full prescribing information, please visit www.makena.com.
About Feraheme® (ferumoxytol) Injection /Rienso
Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of iron deficiency anemia (IDA) in adult chronic kidney disease (CKD) patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by six issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDAs Orange Book, the last of which expires in June 2023.
Ferumoxytol received marketing approval in Canada in December 2012, where it has been marketed by Takeda as Feraheme, and in the European Union in June 2013 where it has been marketed by Takeda as Rienso. Ferumoxytol received marketing approval in Switzerland in August 2013. Takeda had been commercializing the product outside of the U.S. under a license arrangement with AMAG. In December
2014, AMAG and Takeda mutually agreed to terminate the license arrangement and are in the process of transferring the licensed rights back to AMAG.
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components. Serious hypersensitivity reactions, including anaphylactic-type reactions, have been reported in patients receiving Feraheme/Rienso. Serious adverse reactions of clinically significant hypotension have been reported in the post-marketing experience of Feraheme.
For additional U.S. product information, including full prescribing information, please visit www.feraheme.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including among others, statements regarding AMAGs expectations as to preliminary fourth quarter and full year financial results, including total revenues, net product sales (actual and pro forma), operating expenses, adjusted EBITDA and net income, as well as year-end cash and debt balances; AMAGs 2015 goals, including product sales growth across the portfolio, execution on the lifecycle management program for Makena, plans to realize EBITDA margin on product sales in excess of 50%, determining the path forward, if any, for the broad IDA indication for Feraheme and the further expansion of AMAGs product portfolio; AMAGs 2015 financial outlook, including revenues, non-GAAP adjusted EBITDA and non-GAAP cash earnings, the Lumara Health integration effort; AMAGs financing capacity; and AMAGs goals, including to bring to market therapies that improve patients lives and enhance treatment accessibility and plans to continue to expand and diversify AMAGs portfolio, 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: (1) demand for Feraheme and AMAGs ability to successfully compete in the intravenous iron replacement market as a result of the FDAs recommended label changes, including a boxed warning which would provide, among other things, (i) that Feraheme be administered only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions, (ii) observation for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following infusion and (iii) that hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated; (2) the outcome and timing of the process in accordance with Section 505(o) of the Federal Food, Drug and Cosmetic Act whereby the FDA is authorized to require AMAG to make safety-related label changes, including prescribed periods for submitting proposed changes to the label recommended by the FDA; (3) the impact on sales if AMAG disseminates future Dear Healthcare Provider letters; (4) the ability of AMAG to invest in, or AMAGs decision to suspend, the development and commercialization of Feraheme/Rienso outside the U.S.; (5) uncertainties regarding the likelihood and timing of potential approval of Feraheme/Rienso in the U.S., the EU and Canada in the broader IDA indication; (6) the possibility that following review of new safety information, the FDA or regulators in Europe and Canada will request additional technical or scientific information, new studies or reanalysis of existing data, on-label warnings, post-marketing requirements/commitments or risk evaluation and mitigation
strategies (REMS) in the current CKD indication for Feraheme/Rienso, or cause Feraheme/Rienso to be withdrawn from the market, and the additional costs and expenses that will or may be incurred in connection with such activities; (7) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso or Makena and in turn affect sales or AMAGs ability to market such product; (8) AMAGs patents and proprietary rights; (9) maintaining the benefits associated with Makenas orphan drug exclusivity status and AMAGs ability to successfully implement the lifecycle management program; (10) the risk of an Abbreviated New Drug Application (ANDA) filing, especially (i) as to Feraheme following the FDAs draft bioequivalence recommendation for ferumoxytol published in December 2012 and (ii) as to Makena given the history of the formerly FDA-approved drug Delalutin (the original version of 17-alpha-hydroxyprogesterone caproate) for conditions other than reducing the risk of preterm birth; (11) AMAGs ability to execute on, or to realize the expected results from, its long-term strategic plan; (12) the possibility that AMAG will not realize expected synergies and other benefits from its acquisition of Lumara Health, as well as AMAGs ability to pursue additional business development opportunities, especially in light of AMAGs being highly leveraged; (13) the impact on sales of Makena from competitive, commercial payor, government (including federal and state Medicaid reimbursement policies), physician, patient or public responses with respect to product pricing, product access and sales and marketing initiatives, as well as patient compliance and the number of preterm birth risk pregnancies for which Makena may be prescribed; (14) the likelihood that labeling changes may be used to support product liability claims that the prior product labeling did not adequately disclose the risk of adverse events; (15) compliance with restrictive and affirmative covenants with respect to substantial indebtedness incurred to finance the acquisition of Lumara Health, including a requirement that AMAG reduce its leverage over time; (16) the possibility that AMAG will need to raise additional capital from the sale of its common stock, which will cause significant dilution to its stockholders, in order to satisfy its contractual obligations, including its debt service, milestone payments that may become payable to Lumara Healths former stockholders, or in order to pursue business development activities; (17) the availability and timing of tax net operating loss carryforwards; (18) the manufacture of AMAGs products, including any significant interruption in the supply of raw materials or finished product and (19) other risks identified in AMAGs filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 and subsequent filings with the SEC. Any of the above risks and uncertainties could materially and adversely affect AMAGs results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAGs stock price. Use of the term including in the two paragraphs above shall mean in each case including, but not limited to. 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® and Feraheme® are registered trademarks of AMAG Pharmaceuticals, Inc. Lumara Health is a trademark of Lumara Health Inc. Makena® is a registered trademark of Lumara Health Inc. MuGard® is a registered trademark of PlasmaTech Biopharmaceuticals, Inc.
(formerly known as Access Pharmaceuticals, Inc.). Rienso is a trademark of Takeda Pharmaceutical Company Limited.
Non-GAAP Financial Measures Reconciliation for Forward-Looking Guidance
($ in millions) |
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2015 Guidance |
|
GAAP Net Income |
|
$95 - $105 |
|
Add depreciation and amortization of intangibles |
|
$50 - $55 |
|
Add interest expense, net |
|
$40 |
|
EBITDA |
|
$185 - $200 |
|
Less non-cash collaboration revenue |
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$(41) - $(42) |
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Add non-cash inventory step-up |
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$10 - $12 |
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Add stock compensation |
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$12 - $14 |
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Add severance and restructuring |
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$2 - $3 |
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Add adjustment to contingent consideration |
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$15 - $16 |
|
Adjusted EBITDA |
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$180 - $200 |
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Less cash interest expense, net |
|
$(30) |
|
Cash earnings |
|
$150 - $170 |
|
Non-GAAP Financial Measures Reconciliation of Net Income to Adjusted EBITDA
($ in millions) |
|
Q4 2013 |
|
Q4 2014 |
|
2013 |
|
2014 |
| ||||
GAAP Net Income / (loss) |
|
$ |
(3.7 |
) |
$ |
143.0 |
|
$ |
(9.6 |
) |
$ |
135.8 |
|
Add depreciation and amortization of intangibles |
|
$ |
0.3 |
|
$ |
1.5 |
|
$ |
3.2 |
|
$ |
2.1 |
|
Add interest income (expense), net |
|
$ |
(0.3 |
) |
$ |
6.8 |
|
$ |
(1.1 |
) |
$ |
13.5 |
|
Less income tax benefit |
|
|
|
$ |
(153.2 |
) |
|
|
$ |
(153.2 |
) | ||
EBITDA |
|
$ |
(3.7 |
) |
$ |
(1.9 |
) |
$ |
(7.5 |
) |
$ |
(1.8 |
) |
Less non-cash collaboration revenue |
|
$ |
(2.0 |
) |
$ |
(2.3 |
) |
$ |
(8.0 |
) |
$ |
(8.2 |
) |
Add non-cash inventory step-up |
|
|
|
$ |
4.8 |
|
|
|
$ |
4.8 |
| ||
Add stock compensation |
|
$ |
2.1 |
|
$ |
2.4 |
|
$ |
8.0 |
|
$ |
8.6 |
|
Add adjustment to contingent consideration |
|
$ |
0.8 |
|
$ |
1.9 |
|
$ |
1.1 |
|
$ |
(0.6 |
) |
Add severance, restructuring, non-recurring costs |
|
|
|
$ |
9.6 |
|
$ |
0.8 |
|
$ |
11.5 |
| |
Adjusted EBITDA |
|
$ |
(2.8 |
) |
$ |
14.5 |
|
$ |
(5.6 |
) |
$ |
14.3 |
|
CONTACT:
AMAG Pharmaceuticals, Inc.
Katie Payne, 617-498-3303
Exhibit 99.2
AMAG Pharmaceuticals 4Q14 Financial Results February 9, 2015 |
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including among others, statements regarding AMAGs expected strong cash flow and earnings; beliefs about AMAGs positioning for future acquisitions; expected annual synergy cost-savings with the Lumara Health transaction; the market opportunity for Makena®, including market dynamics and opportunities to increase market share and enhance patient compliance; Makenas growth strategies for 2015; expected regulatory actions, and timing of such actions, for Feraheme® in the U.S. and abroad, including for the broad iron deficiency anemia (IDA) indication, the transfer of marketing authorizations from Takeda and potential U.S. label changes; Feraheme growth opportunities and Ferahemes competitive landscape, including opportunities to increase market share in the chronic kidney disease (CKD) market and market opportunity growth if approval of the broader label is pursued and received; expected results for the quarter and year ended December 31, 2014, including net sales, operating loss, net income and adjusted EBITDA, as well as AMAGs expected cash and investments balance; AMAGs 2015 financial guidance, including net product sales, adjusted EBITDA and cash earnings; AMAGs future expansion opportunities, including those related to Makenas line extension and lifecycle management program and AMAGs business development targeting strategy; and AMAGs 2015 goals, including product growth across the portfolio, execution on Makenas line extension/lifecycle management program, the path forward (if any) for the broad IDA indication in the U.S. and plans to further expand AMAGs product portfolio 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: (1) demand for Feraheme and AMAGs ability to successfully compete in the intravenous iron replacement market as a result of the FDAs recommended label changes, including a boxed warning which would provide, among other things, (i) that Feraheme be administered only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions, (ii) observation for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following infusion and (iii) that hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated; (2) the outcome and timing of the process in accordance with Section 505(o) of the Federal Food, Drug and Cosmetic Act whereby the FDA is authorized to require AMAG to make safety-related label changes, including prescribed periods for submitting proposed changes to the label recommended by the FDA; (3) the impact on sales if AMAG disseminates future Dear Healthcare Provider letters; (4) the ability of AMAG to invest in the development and commercialization of Feraheme/Rienso outside the U.S. (Rienso is the trade name for ferumoxytol outside of the U.S. and Canada) , and the level of commercial success of any of such efforts, given the December 2014 arrangement to terminate AMAGs and Takedas license arrangement; (5) uncertainties regarding the likelihood and timing of potential approval of Feraheme/Rienso in the U.S., the EU and Canada in the broader IDA indication; (6) the possibility that following review of new safety information, the FDA or regulators in Europe and Canada will request additional technical or scientific information, new studies or reanalysis of existing data, on-label warnings, post-marketing requirements/commitments or risk evaluation and mitigation strategies (REMS) in the current CKD indication for Feraheme/Rienso, or cause Feraheme/Rienso to be withdrawn from the market, and the additional costs and expenses that will or may be incurred in connection with indication for Feraheme/Rienso, or cause Feraheme/Rienso to be withdrawn from the market, and the additional costs and expenses that will or may be incurred in connection with such activities; (7) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso or Makena and in turn affect sales or AMAGs ability to market such product; (8) AMAGs patents and proprietary rights; (9) maintaining the benefits associated with Makenas orphan drug exclusivity status and the ability to successfully implement the lifecycle management program/line extensions; (10) the risk of an Abbreviated New Drug Application (ANDA) filing, especially (i) as to Feraheme following the FDAs draft bioequivalence recommendation for ferumoxytol published in December 2012 and (ii) as to Makena given the history of the formerly FDA-approved drug Delalutin (the original version of 17-alpha-hydroxyprogesterone caproate) for conditions other than reducing the risk of preterm birth; (11) AMAGs ability to execute on, or to realize the expected results from, its long-term strategic plan; (12) the possibility that AMAG will not realize expected synergies and other benefits from its acquisition of Lumara Health, as well as AMAGs ability to pursue additional business development opportunities, especially in light of AMAGs being highly leveraged; (13) the impact on sales of Makena from competitive, commercial payor, government (including federal and state Medicaid reimbursement policies), physician, patient or public responses with respect to product pricing, product access and sales and marketing initiatives, as well as patient compliance and the number of preterm birth risk pregnancies for which Makena may be prescribed; (14) the likelihood that labeling changes may be used to support product liability claims that the prior product labeling did not adequately disclose the risk of adverse events; (15) compliance with restrictive and affirmative covenants with respect to substantial indebtedness incurred to finance the acquisition of Lumara Health, including a requirement that AMAG reduce its leverage over time; (16) the possibility that AMAG will need to raise additional capital from the sale of its common stock, which will cause significant dilution to its stockholders, in order to satisfy its contractual obligations, including its debt service, milestone payments that may become payable to Lumara Healths stockholders, or in order to pursue business development activities; (17) the availability and timing of tax net operating loss carryforwards; (18) the manufacture of AMAGs products, including any significant interruption in the supply of raw materials or finished product and (19) other risks identified in AMAGs filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 and subsequent filings with the SEC. Any of the above risks and uncertainties could materially and adversely affect AMAGs results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAGs stock price. Use of the term including in the two paragraphs above shall mean in each case including, but not limited to. 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® and Feraheme® are registered trademarks of AMAG Pharmaceuticals, Inc. Lumara Health is a trademark of Lumara Health Inc. Makena® is a registered trademark of Lumara Health Inc. MuGard® is a registered trademark of PlasmaTech Biopharmaceuticals, Inc. (formerly known as Access Pharmaceuticals, Inc.). Rienso is a trademark of Takeda Pharmaceutical Company Limited. Forward-Looking Statements |
Agenda Topic Speaker Opening Remarks Commercial Performance Makena Bill Heiden, CEO Commercial Performance Feraheme Future Expansion Opportunities Frank Thomas, COO Financial Update Scott Holmes, SVP, Finance and IR 2015 Corporate Goals Closing Remarks Bill Heiden, CEO |
Investment Highlights High-growth spec pharma company Expected strong cash flow and earnings Diversified portfolio in attractive market segments Proven leadership team Track record of operational excellence Well positioned for future product acquisitions Maternal Health Hematology/Oncology, Nephrology & Hospital Key Financials (as of 12/31/14) 2014 pro forma product sales: $252MM1 Market cap: $1.1B Shares outstanding (basic): 25.6 million Cash balance: $144MM Debt: $540MM 1 Includes AMAG and Lumara Health product sales as though Lumara Health maternal health business had been acquired at the beginning of 2014 |
Financial Performance Highlights 2014: Outperformed financial guidance Feraheme (U.S.) $86MM in annual sales (+21% vs. 2013) Drove robust IV iron market growth (+7% in 2014) and rising net revenue per gram Makena $166MM in annual pro forma sales Strong physician demand growth: +75% 4Q14 vs. 4Q13 4Q14: Strong financial performance Total revenue of $53MM (+145% vs. 4Q13) $47MM in product sales (+145% vs. 4Q13) $15MM in adjusted EBITDA $153MM tax benefit recognized as a result of Lumara Health transaction Lumara Health transaction financially transformative Transaction completed ahead of schedule Integration substantially complete; $20MM expected annual synergies Enterprise value +350% and market cap +100% since announcement on Sept. 29, 2014 |
Makena |
Overview of Preterm birth (<37 weeks) is a significant public health concern, and history of preterm birth is a leading risk factor Makena (hyroxyprogesterone caproate injection) is the only FDA-approved therapy to reduce recurrent preterm birth in certain at-risk women Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline recommends hydroxyprogesterone caproate weekly injections for pregnant women who meet clinical indication Weekly injections from 16 until 37 weeks of pregnancy (or delivery) Supported by an experienced commercial team focused on maternal health |
$1B Market Opportunity1 Favorable market dynamics: Federal Drug Quality and Security Act (enacted Nov. 2013) details new regulations and FDAs authority governing compounding pharmacies. FDA has stated: When FDA identifies a pharmacist that compounds regularly or in inordinate amounts any drug products that are essentially copies of Makena , it intends to take action as it deems appropriate. Significant opportunity to: Increase market share of treated Makena patients from current 25%; and Support patient compliance to therapy (from current 13.5 avg. paid injections/patient to 21 max. possible injections) Estimated Market Share Based on Patients2 Compounded hydroxyprogesterone caproate ~65K (45%) Off- guidance3 ~42K (30%) Makena ~33K (25%) 1 Based on 140,000 patients, >16 injections/patient and net revenue of ~ $425/injection 2 Company estimates based on Makena shipped doses and quantitative physician market research data on compounded hydroxyprogesterone caproate 3 Off-guidance represents patients treated outside guidance of SMFM including patients treated with unapproved therapies and untreated patients |
Strong Quarterly Growth: 4Q14 vs. 4Q13 75% growth 2014 Sales Performance $166MM pro forma sales, +64% volume growth Shipped doses (in thousands) |
Patient-Centric Growth Strategy Facilitate timely, unencumbered patient access to therapy Collaborate with patient and provider community Focus on patient outcomes |
Patient-Centric Growth Strategy Facilitate timely, unencumbered access to therapy Milestones: >50% of patients now referred through proprietary Makena Care Connection support center Significant progress made with key commercial payers and state Medicaid programs (removing reimbursement barriers) e.g., South Carolina Medicaid 45 compounding pharmacies now dispensing Makena (+10 since Lumara Health transaction closed) |
Patient-Centric Growth Strategy Collaborate with patient and provider community Milestones: Investment in new field-based medical affairs team in 2015 Education on guidelines, risk factors and costs/complications of preterm birth Formed independent external Publications Committee of leading KOLs Strong presence at last weeks SMFM Annual Pregnancy Meeting More than 2,500 leading maternal-fetal medicine specialists in attendance |
Patient-Centric Growth Strategy Focus on patient outcomes Milestones: Launch of adherence/persistency program in 2Q15 Improve upon current 13.5 average injections/patient Line extensions/lifecycle management January 2015 FDA meeting: Regulatory advice on additional lifecycle management/line extension projects Introduction of single-dose vial |
Makena® Single-Dose Vial FIRST LINE EXTENSION Application filed: 4Q14 Decision expected: 2Q15 Potential launch1: Mid-2015 NEW! Customer-friendly configuration Reduces some reimbursement challenges of multi-dose vial Offers a preservative-free option for patients Offers new flexibility with both 5- dose and single-dose vials remaining available Improved efficiency for patient access programs Helps support patient compliance Single-dose vials1 5-dose vial 1 If regulatory approval is received |
Feraheme |
Feraheme: 123 1 GRAM | 2 DOSES | 3 DAYS APART WHY IRON THERAPY IS IMPORTANT Iron is a critical factor in the production of red blood cells 4.5 million Americans diagnosed and suffering from IDA Daily oral iron is first line therapy for most IDA patients Many patients fail oral iron therapy compliance, efficacy and/ or side effects (constipation, GI upset) ATTRIBUTE FERAHEME ONE-GRAM DOSE Dosing1 Schedule: 2 x 510 mg doses Delivery2: 15 min. infusion or IV injection Regimen (1 g): 2 treatments, 3 to 8 days apart Observation Period: 30 minutes post dosing Feraheme Indication: Feraheme ® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components. For full prescribing information, please visit www.feraheme.com. 1One gram of IV iron is the usual therapeutic course and that which was studied in the Feraheme clinical trials 2Revisions to administration procedure under review and discussion with the FDA |
Strong Quarterly Growth: Ex-factory net sales1 (in millions) 4Q14 vs. 4Q13 17% Growth1 (+12% volume, +5% price) 1 Excludes the impact of favorable changes in estimates made to product returns and Medicaid reserves in 2014 and 2013 2014 Sales Performance1 $85MM annual sales +19% growth (12% volume; 7% price) |
Regulatory Update: Rienso & Feraheme Rienso EU; Feraheme Canada 4Q14 Entered into agreement with Takeda to regain worldwide marketing rights EU 1Q15 Takeda (in collaboration with AMAG) withdrew Type II Variation in the EU following feedback that approval was unlikely Currently evaluating commercial viability with CKD-only indication and costs to remain on market 2014 sales of <$0.5MM Considering product withdrawal and future re-submission for broad IDA label with additional data Canada 2H15 Health Canada expected to render a final decision on IDA label supplement Transfer of marketing authorization to take place in 2015 Feraheme U.S. U.S. Feraheme label changes 2Q14 Proposed changes to FDA to strengthen warnings and precautions 1Q15 FDA responded and notified company of additional proposed changes AMAG plans to work with the FDA to finalize an updated Feraheme label U.S. broad IDA label Awaiting feedback from FDA regarding study design submitted to FDA in 2014 Determine potential path forward |
Growth Opportunities: INCREASE SHARE OF CKD MARKET & PLAN FOR LABEL EXPANSION3 32% 1AMAG estimates market opportunity based on $550/gram 2IMS Health Data 3 If regulatory approval is pursued and received ~$500 MILLION/YEAR FERAHEME POTENTIAL3 (900,000 GRAMS OR APPROX. 550,000 PATIENTS) IV Iron IDA3 68% IV Iron IDA-CKD Significant growth opportunity today in current U.S. indication: ~$250 million/year Feraheme potential1 (450,000 grams2 or approx. 275,000 patients) other IV irons Market growth opportunity: 4.5 million diagnosed IDA patients (1.5 million in womens health) |
Future Expansion Opportunities |
Reformulation and drug delivery technologies Expanding Product Portfolio Filed/ Under Regulatory Review Marketed Dosing Market Drugs Oral mucositis/stomatitis and other types of oral wounds Indication Reduces the risk of recurrent preterm birth in certain at-risk women 5 mL vial US 510mg vial Iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) US/EU/ Canada 510mg vial All adult patients with IDA who have failed oral iron 1 mL vial preservative-free US US US Maternal Health Anemia Management Cancer Supportive Care In development US1/EU2/ Canada2 8 oz bottle 1 sNDA submitted December 2012; CRL received January 2014; awaiting feedback on study design to generate additional safety data 2 Ferumoxytol is sold under the trade name RiensoTM in the EU and under the trade name Feraheme in Canada; approval of label expansion unlikely without additional data |
CHANNEL Clinic-based and specialty Hospital products Buy and bill products Sophisticated contracting and reimbursement skills Business Development Targeting Strategy CRITERIA & CONSIDERATIONS HIGH-PRIORITY BD TARGETS ATTRACTIVE MARKET FUNDAMENTALS STRATEGIC FIT ACTIONABLE THERAPEUTIC Maternal and neonatal health Hematology/oncology Nephrology Orphan indications FINANCIAL Revenue-generating commercial products Products with IP runway Late-stage development assets with significant growth potential |
AMAG: Positioned for Accelerated Growth 1If regulatory approval is pursued and received 2Total debt divided by EBITDA Feraheme (CKD) MuGard Makena Product 4 Product 5 Feraheme (IDA1) Past Present (2015) Future Products and Sales Single product Three products Diversified Portfolio <20% growth >200% growth Strong CAGR One therapeutic area Commercial asset Two therapeutic areas Commercial assets Two+ therapeutic areas Commercial and mature late-stage development assets Gross Margin ~80% >90% Significant gross margins EBITDA Margin Negative >50% Sustained growth in EBITDA Cash Flows Significant cash burn +$150MM Significant cash generation Leverage Ratio2 --- Beginning: ~3.7x Ending: <2.0x TBD |
Financial Update |
Fourth Quarter 2014 Results 1Includes $1.8MM favorable changes in estimated product return reserves 2Net income in 4Q14 includes $153 million tax benefit recognized as a result of Lumara Health transaction 3See slide 28 for non-GAAP adjusted EBITDA reconciliation ($ in millions) 4Q13 (unaudited) 4Q14 (unaudited) U.S. Feraheme net sales $19.0 $24.11 Makena net sales -- $22.5 Total revenues $21.7 $53.3 Operating loss $(4.0) $(3.4) Net income / (loss) $(3.7) $143.02 Earnings per share (basic / diluted) $(0.17) / $(0.17) $5.98 / $4.67 Adjusted EBITDA3 $(2.8) $14.5 Ending cash and investments $213.8 $144.2 |
2015 Financial Guidance 12014 Makena sales recorded by AMAG represents sales from November 12, 2014 through December 31, 2014 (post acquisition period) 2See slides 28 and 29 for reconciliation of historical non-GAAP adjusted EBITDA and forecasted non-GAAP adjusted EBITDA and cash earnings, respectively ($ in millions) 2014 RESULTS (unaudited) 2015 GUIDANCE Makena net sales $22.5 1 $245$270 Feraheme and MuGard net sales $87.5 $90$105 Total product sales $110.0 $335$375 Total revenue $124.4 $380$420 Adjusted EBITDA2 $14.3 $180$200 Cash earnings2 --- $150$170 |
2015 Goals BUILDING A HIGH-GROWTH SPEC PHARMA COMPANY Drive significant (+200%) sales growth across AMAGs diversified product portfolio Makena Feraheme MuGard® Mucoadhesive Oral Wound Rinse Establish profitability with adjusted EBITDA margin on product sales in excess of 50% Continue to execute on Makena multi-pronged line extension/lifecycle management program, including potential 1mL approval and launch Determine potential path forward for Feraheme for the broad IDA indication in the U.S. with input from the FDA Further expand the companys product portfolio through acquisition or in-licensing of specialty pharmaceutical products or companies |
AMAG Pharmaceuticals 4Q14Financial Results February 9, 2015 |
Adjusted EBITDA Reconciliation ($ in millions) Q4 2013 (UNAUDITED) Q4 2014 (UNAUDITED) 2013 (UNAUDITED) 2014 (UNAUDITED) GAAP Net income $(3.7) $143.0 $(9.6) $135.8 Add depreciation & amortization of intangibles $0.3 $1.5 $3.2 $2.1 Add interest expense, net $(0.3) $6.8 $(1.1) $13.5 Less income tax benefit ---- $(153.2) ---- $(153.2) EBITDA $(3.7) $(1.9) $(7.5) $(1.8) Less non-cash collaboration revenue $(2.0) $(2.3) $(8.0) $(8.2) Add non-cash inventory step-up ---- $4.8 ---- $4.8 Add stock compensation $2.1 $2.4 $8.0 $8.6 Add adjustment to contingent consideration $0.8 $1.9 $1.1 $(0.6) Add severance & transaction related costs ---- $9.6 $0.8 $11.5 Adjusted EBITDA $(2.8) $14.5 $(5.6) $14.3 |
2015 Financial Guidance: ADJUSTED EBITDA AND CASH EARNINGS RECONCILIATION ($ in millions) 2015 GUIDANCE GAAP Net income $95 $105 Add depreciation and amortization of intangibles $50 $55 Add interest expense, net $40 EBITDA $185 $200 Less non-cash collaboration revenue $(41) $(42) Add non-cash inventory step-up $10 $12 Add stock compensation $12 $14 Add adjustment to contingent consideration $15 $16 Add severance and restructuring $2 $3 Adjusted EBITDA $180 $200 Less cash interest expense $(30) Cash earnings $150 $170 |