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): August 1, 2013
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.) |
100 Hayden Avenue |
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Lexington, Massachusetts |
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02421 |
(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)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 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 August 1, 2013, AMAG Pharmaceuticals, Inc., or the Company or the Registrant, issued a press release regarding its operating results and revenues for the quarter and six-months ended June 30, 2013 and its intention to hold a conference call to discuss the Companys financial results, commercial progress and business development initiatives. 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 8.01. Other Events.
The purpose of the disclosure in this Item 8.01 is to provide a description of the Registrants common stock, par value $0.01 per share, or the Common Stock. As permitted by guidance published by the U.S. Securities and Exchange Commission, or the Commission, this description is being provided for purposes of Commission forms that require the incorporation by reference of a description of securities contained in a registration statement filed under the Securities Exchange Act of 1934, as amended.
Description of Common Stock
The Registrant is authorized to issue up to 58,750,000 shares of Common Stock.
Holders of Common Stock are entitled to one vote per share and vote together as a single class on all matters to be voted on by the Registrants stockholders. There are no cumulative voting rights in the election of directors. The approval of corporate actions may also require the approval of the holders of any series of the Registrants preferred stock.
The Registrants Common Stock will be the only type of capital stock entitled to vote in the election and removal of directors and other matters presented to the Registrants stockholders from time to time, unless the Registrant issues voting preferred stock or the Registrants certificate of incorporation or the law requires otherwise.
The Registrants common stockholders will be entitled to receive dividends and distributions declared by the Registrants board of directors, to the extent permitted by outstanding series of preferred stock and by the Registrants certificate of incorporation. If a dividend is declared, it will be distributed pro rata to common stockholders on a per share basis.
If the Registrant is liquidated or dissolved, the Registrants common stockholders will be entitled to receive assets and funds available for distribution to common stockholders in proportion to the number of shares they hold. The Registrants common stockholders may not receive any assets or funds until the Registrants creditors have been paid in full and the
preferential or participating rights of the Registrants preferred stockholders, if any, have been satisfied.
Holders of Common Stock will not have any preemptive, subscription or conversion rights with respect to shares of Common Stock. The Registrant may issue additional shares of Common Stock, if authorized by its board of directors, without the common stockholders approval, unless required by Delaware law or a stock exchange on which the Registrants securities are traded. The issuance of additional shares could have the effect of diluting any earnings per share and the book value per share of outstanding shares of Common Stock. If the Registrant receives the appropriate payment, shares of Common Stock that the Registrant issues will be fully paid and nonassessable.
The foregoing description is a summary of the terms of the Common Stock and is qualified in its entirety by the provisions of the Registrants certificate of incorporation and bylaws, which have been filed with the Commission as Exhibit 3.1 to the Registrants Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and Exhibit 3.1. to the Registrants Current Report on Form 8-K filed November 28, 2008, respectively. A description of the Registrants Preferred Share Purchase Rights can be found under Item 3.03 of the Registrants Current Report on Form 8-K filed September 4, 2009.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The Company hereby furnishes the following exhibits:
99.1 Press Release dated August 1, 2013.
99.2 Copy of presentation slides of the Company during August 1, 2013 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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General Counsel and Senior Vice President of Legal Affairs |
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Date: August 1, 2013 |
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Exhibit 99.1
FOR IMMEDIATE RELEASE
AMAG Announces Second Quarter and Six Month 2013 Financial Results
Record Provider Demand Drives 29% Increase in U.S. Net Feraheme Revenues
Company Updates Financial Guidance; Increases Revenue Projections for 2013
Conference call scheduled for 8:00 a.m. EDT today
LEXINGTON, MA (August 1, 2013) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company, today reported unaudited consolidated financial results for the quarter and six months ended June 30, 2013. Total revenues for the second quarter of 2013 were $19.6 million, of which $17.5 million were U.S. Feraheme® (ferumoxytol) sales, the highest Feraheme quarterly sales since launch.
We set ambitious goals for the year and based on our many successes in the first half of 2013, I am pleased to report that we are well on our way to meeting or exceeding those goals, said William Heiden, president and chief executive officer of AMAG. So far in 2013, Ferahemes growth trajectory has accelerated, our business development efforts have begun to bear fruit, and we continue to operate our business with financial discipline. Additionally, we have been busy planning for the future preparing for the potential expansion of Ferahemes labeled indication and announcing several new key executive hires, whose contributions will help AMAG deliver on our vision of building a profitable, high-growth multi-product company focused on improving patients lives.
Business Highlights
· The company reported record U.S. Feraheme net product sales of $17.5 million in the second quarter of 2013, compared to $13.5 million (excluding $0.6 million reduction of reserves for product returns) in the second quarter of 2012, representing a 29 percent increase. AMAGs focused commercial strategy is resulting in increased utilization of Feraheme for the treatment of iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients and an increase in net revenue per gram of Feraheme compared to the second quarter of 2012.
· Feraheme gained a full point of market share in the second quarter compared to the end of the first quarter of 2013, capturing 15 percent of the total volume of the U.S. non-dialysis IV iron market. Total Feraheme provider demand for the second quarter of 2013 hit a record level at approximately 33,500 grams, compared to approximately 28,200 grams in the second quarter of 2012.(1)
· During the second quarter, Takeda Pharmaceutical Company Ltd., AMAGs commercial partner in the European Union (E.U.), submitted a regulatory filing with the European Medicines Agency for ferumoxytol, seeking to expand the indication for Rienso® (the brand name for ferumoxytol in the
(1) IMS Health
E.U.) beyond the current CKD indication to include all adult patients with IDA who have failed or otherwise cannot take oral iron therapy, with an anticipated action date in the first half of 2014.
· The company is preparing for the potential expansion of Ferahemes labeled indication. The company submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in December 2012 seeking to expand the label to include all adult patients with IDA who have failed or otherwise cannot take oral iron therapy; the FDA accepted the filing and, in accordance with the Prescription Drug User Fee Act (PDUFA) guidelines, is targeting October 21, 2013 as the PDUFA action date for the filing.
· In June, AMAG in-licensed the U.S. commercial rights to MuGard, a marketed product for the management of oral mucositis, from Access Pharmaceuticals, Inc. MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients developing the condition each year. The Company is currently in the process of transitioning MuGard promotion to AMAGs sales force.
Second Quarter and Six Month 2013 Financial Results (unaudited)
The hard work and dedication of each and every member of our organization has resulted in exceptional financial performance to date in 2013, commented Frank Thomas, chief operating officer of AMAG. Our impressive product revenue growth and disciplined expense management have driven our companys quarterly cash burn down to just $1.4 million, excluding the license fee paid for MuGard, and has put us on a clear trajectory toward profitability.
The company reported record U.S. Feraheme net product sales of $17.5 million in the second quarter of 2013, compared to $13.5 million (excluding $0.6 million reduction of reserves for product returns) in the second quarter of 2012. For the six months ended June 30, 2013, AMAG reported U.S. Feraheme net product sales of $33.0 million, compared to $26.6 million (excluding $1.1 million reduction of reserves for product returns) for the same period in 2012. Total revenues for the quarter ended June 30, 2013 were $19.6 million, as compared to $31.0 million for the second quarter of 2012. For the six months ended June 30, 2013, AMAG reported total revenues of $37.5 million, as compared to revenues of $46.5 million for the same period in 2012. Total revenues for the second quarter and six month 2012 periods were favorably impacted by the recognition in June 2012 of a $15 million milestone payment associated with EU regulatory approval of ferumoxytol.
Feraheme cost of goods sold (COGS) for the quarters ended June 30, 2013 and 2012 were $3.1 million, which represents 18 percent of Feraheme net product revenues for the 2013 period and 22 percent of Feraheme net product revenues for the 2012 period. For the six months ended June 30, 2013, Feraheme COGS were $5.9 million, or 18 percent of Feraheme net product revenues, compared to $5.7 million, or 21 percent of Feraheme net product revenues, for the same period in 2012. The decrease in Feraheme COGS for the 2013 periods was due to the companys decision to change to a fully outsourced supply chain, which was implemented in late 2012.
Total operating expenses for the quarter ended June 30, 2013 were $19.3 million, 15 percent lower than the $22.8 million (excluding restructuring charges) reported for the second quarter of 2012. Total operating expenses for the six months ended June 30, 2013 were $38.7 million, 20 percent lower than the $48.4 million
reported for the same period in 2012. The decreases in total operating expenses in the 2013 periods were due primarily to decreased research and development costs associated with the companys global iron deficiency anemia (IDA) registration program and the benefits of a corporate restructuring implemented in 2012.
The company reported a net loss of $1.9 million, or a loss of $0.09 per basic and diluted share, for the quarter ended June 30, 2013, as compared to net income of $3.3 million, or $0.16 per basic and $0.15 per diluted share, for the second quarter of 2012. AMAG reported a net loss for the six months ended June 30, 2013 of $5.8 million, or $0.27 per basic and diluted share, as compared to a net loss of $9.1 million, or $0.43 per basic and diluted share, for the same period in 2012.
As of June 30, 2013, the companys cash and investments totaled approximately $212.4 million, reflecting a net cash outflow of approximately $1.4 million during the second quarter, excluding the upfront $3.3 million license fee paid to Access Pharmaceuticals related to MuGard.
2013 Financial Outlook
The company has updated its annual financial guidance for 2013. AMAG now expects to achieve the following in 2013:
· Total revenues of between $77 million and $80 million, including:
· Feraheme U.S. net product sales of between $67 million and $70 million, revised upward from the companys previous estimate of between $63 million and $67 million;
· Revenues from other sources of approximately $10 million, including ex-U.S. Feraheme/Rienso product sales, royalties and amortization of milestones as well as MuGard product sales;
· Feraheme COGS of between 14 percent and 18 percent of net Feraheme global product sales. Total COGS reported will include product costs related to the MuGard license;
· Total operating expenses of between $78 million and $82 million; and
· A 2013 year-end cash and investments balance of between $206 million and $211 million, not including the impact of future business development transactions.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides today at 8:00 a.m. EDT, during which management will discuss the companys financial results, commercial progress and business development initiatives. To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 10:00 a.m. EDT on August 1, 2013 through midnight August 8, 2013. To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access. The pass code for the live call and the replay is 37544923.
The call will be webcast with slides and accessible through the Investors section of the companys website at www.amagpharma.com. The webcast replay will be available from approximately 10:00 a.m. EDT on August 1, 2013 through midnight August 30, 2013.
AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited, amounts in thousands, except for per share data)
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Three Months Ended
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Six Months Ended
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2013 |
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2012 |
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2013 |
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2012 |
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Revenues: |
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U.S. Feraheme product sales, net |
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$ |
17,456 |
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$ |
14,094 |
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$ |
33,034 |
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$ |
27,720 |
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Other product sales and royalties |
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138 |
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326 |
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437 |
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427 |
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License fee and other collaboration revenues |
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2,055 |
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16,592 |
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4,058 |
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18,345 |
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Total revenues |
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19,649 |
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31,012 |
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37,529 |
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46,492 |
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Operating costs and expenses: |
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Cost of product sales |
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3,145 |
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3,224 |
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6,087 |
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5,870 |
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Research and development expenses |
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4,049 |
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7,671 |
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9,453 |
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20,133 |
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Selling, general and administrative expenses |
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15,211 |
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15,101 |
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29,216 |
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28,282 |
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Restructuring expenses |
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1,058 |
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1,058 |
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Total operating costs and expenses |
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22,405 |
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27,054 |
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44,756 |
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55,343 |
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Operating income (loss) |
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(2,756 |
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3,958 |
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(7,227 |
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(8,851 |
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Interest and dividend income, net |
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256 |
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338 |
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527 |
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731 |
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Gains on sale of assets |
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566 |
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865 |
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Gains (losses) on investments, net |
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26 |
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(1,471 |
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32 |
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(1,471 |
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Net income (loss) before income taxes |
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(1,908 |
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2,825 |
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(5,803 |
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(9,591 |
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Income tax benefit |
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494 |
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494 |
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Net income (loss) |
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$ |
(1,908 |
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$ |
3,319 |
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$ |
(5,803 |
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$ |
(9,097 |
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Net income (loss) per share |
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Basic |
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$ |
(0.09 |
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$ |
0.16 |
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$ |
(0.27 |
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$ |
(0.43 |
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Diluted |
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$ |
(0.09 |
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$ |
0.15 |
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$ |
(0.27 |
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$ |
(0.43 |
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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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21,603 |
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21,370 |
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21,574 |
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21,359 |
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Diluted |
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21,603 |
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21,649 |
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21,574 |
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21,359 |
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AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
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June 30, 2013 |
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December 31, 2012 |
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Cash and cash equivalents |
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$ |
27,802 |
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$ |
46,293 |
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Short-term investments |
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184,611 |
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180,750 |
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Accounts receivable, net |
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8,490 |
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6,410 |
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Inventories |
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13,474 |
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12,451 |
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Receivable from collaboration |
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368 |
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263 |
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Assets held for sale |
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1,934 |
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2,000 |
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Other current assets |
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6,118 |
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6,673 |
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Total current assets |
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242,797 |
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254,840 |
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Property and equipment, net |
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1,913 |
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3,297 |
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Intangible assets, net |
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17,192 |
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Other assets |
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400 |
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Total assets |
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$ |
262,302 |
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$ |
258,137 |
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Accounts payable |
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$ |
2,443 |
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$ |
3,515 |
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Accrued expenses |
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18,256 |
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20,338 |
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Deferred revenues |
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9,269 |
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9,104 |
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Total current liabilities |
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29,968 |
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32,957 |
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Deferred revenues |
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46,402 |
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50,350 |
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Acquisition-related contingent consideration |
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13,044 |
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Other long-term liabilities |
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1,806 |
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2,033 |
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Total long-term liabilities |
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61,252 |
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52,383 |
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Total stockholders equity |
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171,082 |
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172,797 |
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Total liabilities and stockholders equity |
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$ |
262,302 |
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$ |
258,137 |
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About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets Feraheme® (ferumoxytol) Injection and MuGard Mucoadhesive Oral Wound Rinse in the United States. Along with driving organic growth of its products, AMAG intends to expand its portfolio with additional commercial-stage specialty products. The company is seeking complementary products that leverage the companys commercial footprint and focus on hematology and oncology centers and hospital infusion centers. For additional company information, please visit www.amagpharma.com.
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. MuGard is a trademark of Access Pharmaceuticals, Inc. Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.
Forward-looking Statements
This press release contains forward-looking statements 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 but not limited to, the potential expansion of Ferahemes labeled indication and our expectations regarding the FDAs review of our sNDA for Feraheme; expectations regarding our 2013 goals; contributions from new key executive hires; plans for integrating MuGard into our commercial teams selling efforts; the markets for Feraheme/Rienso and MuGard; our future revenues and profitability; our expectations for revenue growth from Feraheme/Rienso and MuGard product sales, including our expected 2013 revenues from these sources; our operating expenses and cost of goods sold, including our expected 2013 operating expenses and cost of goods sold; our expected 2013 year-end cash and investments balance; and our plans to expand our 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: (1) uncertainties regarding our and Takedas ability to successfully compete in the intravenous iron replacement market both in the US and outside the US, including the EU, (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the US and outside of the US, including the EU, (3) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (4) uncertainties regarding, and our dependence on third parties for, the manufacture of Feraheme/Rienso, (5) uncertainties relating to our patents and proprietary rights, both in the US and outside of the US, (6) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDAs draft bioequivalence recommendation for ferumoxytol, (7) the risk that we may not realize the anticipated benefits of our licensing arrangement for and integration of MuGard and (8) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
We disclaim 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, Inc. Contact
Amy Sullivan, 617-498-3303
Exhibit 99.2
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AMAG PHARMACEUTICALS 2Q13 Financial Results August 1, 2013 |
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FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform statements contained herein describe Act of 1995 and other federal securities laws. Any which do not historical facts, including but not limited to: (i) our statement that AMAG is well positioned for growth in 2013 and beyond; (ii) the expanded label opportunity for Feraheme; (iii) expectations regarding IV iron referrals and patient and physician behaviors; (iv) the potential for approval and potential launch of the supplemental new drug application in the U.S. and the timing and potential regulatory submission in the EU for Feraheme/Rienso for the broad iron deficiency anemia indication; (statements regarding our GI launch planning; (statements regarding the potential size and expansion v) vi) of the U.S. IV iron market opportunity and patient population; (vii) our expected financial results for 2013, including revenues, operating expenses and cost of goods sold; (viii) our expected cash and investments balance for 2013; (ix) our plans to expand the reach of Feraheme to new indications and geographic territories; (x) our business development activities and plans to execute transactions; (xi) strategies driving Feraheme volume growth; (xii) the emergence of shifting practice patterns in the iron market; xiii) our expectation to increase our market share of the IV iron market in 2013; and (xiv) statements regarding our expectation to deliver on financial guidance, are forwardlooking 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: (1) uncertainties regarding, and our dependence on third parties for, our and Takeda's ability to successfully compete in the intravenous iron replacement market both in the US and outside the US, including the EU, (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the US and outside of the US, including the EU, (3) the possibility that safety or drug interaction problems significant could arise with respect to Feraheme/Rienso, (4) uncertainties regarding the manufacture of Feraheme/Rienso, (5) uncertainties relating to our patents and proprietary rights both in the US and outside the US, (6) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDAs draft bioequivalence recommendation for ferumoxytol, and (7) other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10 Q for the 31 SEC you not to 10-quarter ended March 31, 2013 and subsequent filings with the SEC. We caution place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim 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 |
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AGENDA Topic Speaker Opening Remarks Bill Heiden, CEO Financial Highlights & Outlook Frank Thomas, COO , Commercial Performance Greg Madison, CCO Expansion Opportunities and Closing Remarks Bill Heiden, CEO 3 |
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SECOND QUARTER 2013 HIGHLIGHTS . financial performance 2Q12 Achieved strong vs. . 29% increase in U.S. Feraheme net sales driven by volume and net revenue per gram growth . 15% decrease in operating expenses . Improving gross margins Feraheme . Accelerated growth for Feraheme physician-level demand . Generated record provider demand: 33,500 grams . Prepared for IDA launch in the U.S. . Increase share: attracting new customers for CKD patients today will enable quick update for broad IDA, upon approval p ,p pp . Expand market: plan to increase IV iron conversion rate for patients that fail or dont tolerate oral iron failures to IV iron . Submitted E.U. regulatory filing (type II variation) for ferumoxytol to the European Medicines Agency for broad IDA indication . Successfully concluded first in-licensing deal U S MuGardTM a . Acquired U.S. commercial rights to MuGardTM, supportive care product for oncology that fits with our Feraheme call point . Building world class executive team 4 |
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OVERVIEW FINANCIAL Frank Thomas, Chief Operating Officer |
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FERAHEME ON A SOLID GROWTH TRAJECTORY QUARTERLY U.S. NET FERAHEME SALES U.S. +29% vs 2Q12 $18 (+23% volume, +6% price) $16 +12% vs 2011 volume +19% vs 1Q12 (+14% volume, +5% price) (+17% volume, -5% price) $14 (in millions) $12 $10 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 6 |
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SECOND QUARTER FINANCIAL HIGHLIGHTS ($ in millions, except per share ) 2Q13 2Q12 U.S. Feraheme sales, net $17.5 $13.5* Total revenues $19.7 $31.0** F h G M i $14 4 $10 3* Feraheme Gross Margin % of product sales 14.4 82% 10.3* 78% R&D $4.0 $7.7 Expenses SG&A Expenses $15.2 $15.1 Net (Loss) ($1 9) $3 3 Income 1.9) 3.3 Income (Loss) Per Basic Share ($0.09) $0.16 Cash and investments $212.4 $207.2 Excludes $0.6 million reduction of reserves for product returns ** Includes a $15 million milestone payment. |
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2013 UPDATED FINANCIAL OUTLOOK 2013 Guidance Updated Revenues (in millions) . Total Revenues of $77 - $80 million . $67 $70 million in U.S. Feraheme net $80 $90 sales . $10 million in other revenues (royalty, ex-US product sales, amortization of milestones, MuGard product sales) $50 $60 $70 Other Revenue F h . Operating expenses of $78 $82 million (excluding COGS) F h COGS 14% 18% f $ 20 $30 $40 Feraheme US Expenses (in millions) . Feraheme COGS: 14%-of Feraheme global net sales . End 2013 with $206 $211 million $10 2011 2012 2013 Est. of cash and investments, not including the impact of future business development transactions $110 $130 $50 $70 $90 SG&A R&D 8 $10 $30 2011 2012 2013 Est. |
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FERAHEME PERFORMANCE Greg Madison, Chief Commercial Officer |
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FERAHEME DEMAND GROWTH HAS ACCELERATED 19% 35,000 30,000 11% 25 000 Grams 25,000 20,000 15,000 1Q 2Q 2012 2013 10 Source: IMS Health Data. |
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2Q13: RECORD FERAHEME PROVIDER DEMAND 35,000 2Q13 Results Growth: 25% 25,000 30,000 . 19% increase in Feraheme provider demand; E.I. of 115 2Q12 20,000, Grams vs. Market Share: 26% 15,000 . 15% share of nondialysis IV iron market (+1% vs. 1Q13) 12% 5,000 10,000 . 26% of hem/onc segment; E.I. 105 . 10% of 0 2Q12 2Q13 hospital segment; E.I. 124 Hem/Onc Hospital Other (inc. Nephrology) 11 Source: IMS Health Data. |
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FERAHEME BROAD IDA LABEL EXPANSION PLANS 2012 NDA submitted to FDA Global 1,400 patient phase III program completed 2013 Potential IDA U.S. sNDA approval submission in EU 2014 Potential IDA approval in EU (milestone to AMAG) 12 |
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INCREASE SHARE OF CURRENT IV IRON MARKET 500,000 Patients 800 000 Todays Opportunity: 800,000 grams + $ 400 million Feraheme potential Half (400,000 grams) addressable current Feraheme label Today s . Hematology/Oncology . Strong Feraheme share in CKD with . Loyal and growing account base . Hospitals . Adoption and share increasing p g . 250+ new hospitals purchasing Feraheme compared to 2Q12 IV Iron - IDA-CKD IV Iron - IDA 13 Sources: U.S. Census; U.S. Renal Data System , USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998- 2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 5761; AMAG estimates market opportunity at $500/gram. |
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INCREASE SHARE OF CURRENT IV IRON MARKET 500,000 Patients 800 000 Opportunity: 800,000 grams + $ 400 million Feraheme potential Label Expansion Same call audience: Hematology/Oncology . . Expand use to all IDA patients in current accounts . Convert single IV iron stockers to Feraheme H i l . Hospitals . Expand use to all IDA patients in current accounts . Continue to gain new accounts IV Iron - IDA-CKD IV I IDA Iron - 14 Sources: U.S. Census; U.S. Renal Data System , USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998- 2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 5761; AMAG estimates market opportunity at $500/gram. |
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CURRENT IV IRON MARKET & MARKET EXPANSION POTENTIAL 500,000 patients 800 000 800,000 grams + $ 400 million Feraheme potential 4,000,000 patients diagnosed with IDA placed on oral iron therapy IV Iron - IDA-CKD IV Iron - IDA Oral Iron - IDA Oral Iron - IDA-CKD 15 Sources: U.S. Census; U.S. Renal Data System , USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 5761; AMAG estimates market opportunity at $500/gram. |
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CURRENT IV IRON MARKET & MARKET EXPANSION POTENTIAL 500,000 patients 800 000 800,000 grams + $ 400 million Feraheme potential 4,000,000 patients diagnosed with IDA placed on oral iron therapy IV Iron - IDA-CKD IV Iron - IDA Oral Iron - IDA Oral Iron - IDA-CKD Gastroenterology patients 16 Sources: U.S. Census; U.S. Renal Data System , USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 5761; AMAG estimates market opportunity at $500/gram. |
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IV IRON MARKET EXPANSION: GASTROENTEROLOGY . Increased anemia management in IBD patients focus on . Crohns and Colitis Foundation of America has identified anemia as one of their top 10 quality outcome measures to improve patient care . High interest in prevalence of IDA within specific patient populations . Crohns, celiac, bariatric surgery alone represent more > 400,000 IDA i patients . Physicians recognize IDA as an issue in their patients, but most GEs unaware of new treatment options . Feraheme product profile is compelling . I thought IV iron was more cumbersome than this. Not now! (verbatim from GI Robust efficacy in raising Hemoglobin . Dosing Easy as 1-2-3 . Rapid, less frequent dosing is now easier for IDA patients message testing) . We can target within the Gastroenterology specialty (~ 10,000 GEs in US) AMAG h id ifi d 1 200 ll i i h hi h i l f i . has identified ~1,200 call points with high potential for IV iron 17 |
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BUSINESS DEVELOPMENT OPPORTUNITIES |
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MUGARD LICENSE EXPANDS PRODUCT OFFERING FOR HEMATOLOGY/ONCOLOGY CLINICS . MuGard is a oral oral mucositis prescription rinse for the management of . Designed to form a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue . Oral mucositis is a effect common side of cancer treatment . Approximately 40% of patients receiving chemotherapy and radiation therapy develop oral mucositis (~400,000 patients/year) . MuGard has ~1% share of OM patients . AMAG obtained US commercial rights for MuGard in June 2013 . 3 3 million License fee of $3.3 . Double-digit royalty on net sales payable to Access O ii i h fi AMAGdl i i . Opportunistic transaction that fits AMAG deal criteria . Commercial synergy => direct overlap with current Feraheme physician audience . Significant growth potential/limited downside risk . Accretive to earnings in 2014 . Integration into AMAGs commercial operations ongoing 19 |
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BUSINESS DEVELOPMENT TARGET CATEGORIES B ll E Bulls-Eye Hem/onc or hospital company or product $10-60 MM / yr. revenue potential IP runway Immediately accretive Opportunity for growth Strategic Opportunities aligned with Feraheme growth strategy (e.g. GI, Rheum) Financial Similarly sized (or smaller) specialty company Eliminate overlapping infrastructure and increase EBITDA 20 |
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BUILDING OFF 1H SUCCESSES IN 2013 . year double digit of Feraheme Achieve full double-growth . Drive market share growth (E.I. +100) and market growth . Continue to realize increasing net revenue per gram of Feraheme . Expand Feraheme indication: IDA (non-CKD) oral iron failures . Formal acceptance of sNDA by FDA 1Q13 . EU l b i i 2Q13 regulatory submission . Expected FDA approval & launch in US 4Q13 . Complete pre-launch planning/activities for potential broader IDA indication. Execute one or more business development transaction(. Obtained US commercial rights to MuGard Additional business development projects . Deliver on updated financial guidance . Increasing Feraheme sales guidance 21 |
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AMAG PHARMACEUTICALS Well positioned for growth in 2013... and beyond |