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): April 23, 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:
¨ 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 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 April 23, 2013, AMAG Pharmaceuticals, Inc., or the Company, issued a press release regarding its operating results and revenues for the quarter ended March 31, 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 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The Company hereby furnishes the following exhibits:
99.1 Press Release dated April 23, 2013.
99.2 Copy of presentation slides of the Company during April 23, 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 | |
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Date: April 23, 2013 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
AMAG Announces First Quarter 2013 Financial Results
Total revenue increased 16%, operating expenses decreased 24%, resulting in a 69% reduction in net loss
Conference call scheduled for 4:30 EDT today
LEXINGTON, MA (April 23, 2013) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company, today reported unaudited consolidated financial results for the quarter ended March 31, 2013. Total revenues for the first quarter of 2013 were $17.9 million, 16 percent greater than the first quarter of 2012, driven by increased Feraheme® (ferumoxytol) U.S. sales. As of March 31, 2013, the companys cash, cash equivalents and investments totaled approximately $217 million.
We have gotten off to a very strong start in 2013, delivering record results through a combination of solid top-line growth and disciplined financial management, said William Heiden, president and chief executive officer of AMAG. In the first quarter, we achieved our largest volume of non-dialysis Feraheme sales since launch. Our new chief commercial officer, Greg Madison, and his team did an excellent job of driving Feraheme performance this quarter, achieving especially strong growth in the largest segment of the non-dialysis IV iron market, the hospital segment.
Business Highlights
· The company reported $15.6 million in U.S. Feraheme net product sales, compared to $13.1 million (excluding $0.5 million reduction of reserves for product returns) in the first quarter of 2012, representing a 19 percent increase. The growth in U.S. product sales was driven by 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. Total Feraheme provider demand for the first quarter of 2013 was approximately 29,500 grams, representing an 11 percent increase in provider demand over the first quarter of 2012.(1)
· Total operating expenses for the first quarter of 2013 declined 24 percent compared to the same period in 2012 as the company remains focused on driving the business towards profitability.
· AMAG is beginning to see the positive financial impact of the change to a fully outsourced supply chain that occurred in the fourth quarter of 2012, with gross margin on sales of Feraheme increasing to more than 82 percent in the first quarter of 2013 driven by improvements in cost of goods sold (COGS).
(1) IMS Health
· In March 2013, AMAG received notification that its supplemental new drug application (sNDA) was accepted for review by the U.S. Food and Drug Administration (FDA) and that the FDA is targeting October 21, 2013 as the PDUFA action date for the filing. AMAG submitted the sNDA in December 2012, seeking to expand the indication for Feraheme beyond the current CKD indication to include all adult patients with IDA who have failed or otherwise cannot take oral iron therapy.
· AMAG continues to prepare for the potential approval of its sNDA for Feraheme in patients with IDA, regardless of underlying cause, who cannot take oral iron. These activities include conducting physician market research and product message development and testing. Other related activities include corporate disease awareness initiatives and support for the presentations/publications of data from AMAGs phase III IDA clinical program in medical journals and at medical conferences.
We made several changes to the way we operate our business in 2012, and we are now realizing the full benefit of those changes in our financial results, stated Frank Thomas, chief operating officer of AMAG. The nineteen percent increase in U.S. Feraheme sales versus 2012 was driven by strong volume gains as well as an increase in net revenue per gram, each of which we accomplished while maintaining a lower operating cost structure in the first quarter.
First Quarter 2013 Financial Results (unaudited)
Total revenues for the quarter ended March 31, 2013 were $17.9 million, as compared to $15.5 million for the same period in 2012. The increase in total revenues in the first quarter of 2013 was primarily due to higher Feraheme product sales. Net U.S. Feraheme product sales for the quarter ended March 31, 2013 were $15.6 million, as compared to $13.1 million (excluding a $0.5 million reduction of reserves for product returns) for the same period in 2012.
Feraheme COGS in the first quarter of 2013 were $2.8 million, or 18 percent of global Feraheme product sales, compared to $2.6 million, or 23 percent of Feraheme product sales (excluding $0.5 million reduction of reserves for product returns) in the first quarter of 2012. Total operating expenses for the quarter ended March 31, 2013 were $19.4 million, compared to $25.6 million for the same period in 2012. The decrease in operating expenses in the first quarter of 2013 versus the first quarter of 2012 was primarily attributable to lower research and development expenses due to the 2012 completion of AMAGs phase III IDA clinical program and a leaner internal R&D cost structure.
The company reported a net loss of $3.9 million, or a loss of $0.18 per share, for the quarter ended March 31, 2013, as compared to a net loss of $12.4 million, or a loss of $0.58 per share, for the same period in 2012.
2013 Financial Outlook
The company reiterates the following guidance for 2013:
· Total revenues of between $73 million and $77 million, including:
· Feraheme U.S. net product sales of between $63 million and $67 million;
· Revenue from royalties, ex-U.S. product sales and milestones of approximately $10 million;
· COGS of between 14 percent and 18 percent of net Feraheme global product sales;
· 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 business development transactions.
About Iron Deficiency Anemia
More than 4 million Americans have IDA; 1.6 million of whom are estimated to have CKD, while the other 2.4 million suffer from anemia due to other causes.(2) For these patients with anemia due to other causes, the underlying diseases or issues causing IDA include abnormal uterine bleeding, gastrointestinal disorders, inflammatory diseases and chemotherapy-induced anemia. Many IDA patients fail treatment with oral iron due to intolerability or side effects.(3)
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme® (ferumoxytol) Injection for Intravenous (IV) use in the United States. Along with driving organic growth of its lead product, AMAG intends to expand its portfolio with additional commercial-stage specialty pharmaceuticals. 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.
Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides today at 4:30 p.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 7:30 p.m. EDT on April 23, 2013 through midnight April 30, 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 7:30 p.m. EDT on April 23, 2013 through midnight May 23, 2013.
(2) 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.
(3) Barton, James et al. Intravenous iron dextran therapy in patients with iron deficiency and normal renal function who failed to respond to or did not tolerate oral iron supplementation. Am J Medicine. 2000; 109: 27-32.
AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited, amounts in thousands, except for per share data)
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Three Months Ended March 31, |
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2013 |
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2012 |
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Revenues: |
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U.S. product sales, net |
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$ |
15,578 |
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$ |
13,626 |
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International product sales and royalties |
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63 |
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License fee and other collaboration revenues |
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2,003 |
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1,753 |
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Other product sales and royalties |
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236 |
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101 |
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Total revenues |
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17,880 |
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15,480 |
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Operating costs and expenses: |
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Cost of product sales |
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2,942 |
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2,646 |
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Research and development expenses |
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5,404 |
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12,462 |
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Selling, general and administrative expenses |
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14,005 |
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13,181 |
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Total operating costs and expenses |
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22,351 |
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28,289 |
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Operating loss |
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(4,471 |
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(12,809 |
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Interest and dividend income, net |
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271 |
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393 |
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Other income |
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6 |
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Gain on disposal of fixed assets |
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299 |
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Net loss |
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$ |
(3,895 |
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$ |
(12,416 |
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Net loss per share - basic and diluted |
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$ |
(0.18 |
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$ |
(0.58 |
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Weighted average shares outstanding used to compute net loss per share: |
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Basic and diluted |
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21,544 |
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21,349 |
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AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
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March 31, 2013 |
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December 31, 2012 |
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Cash and cash equivalents |
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$ |
33,845 |
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$ |
46,293 |
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Short-term investments |
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183,224 |
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180,750 |
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Accounts receivable |
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8,519 |
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6,410 |
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Inventories |
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11,292 |
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12,451 |
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Receivable from collaboration |
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108 |
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263 |
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Assets held for sale |
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1,931 |
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2,000 |
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Other current assets |
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6,219 |
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6,213 |
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Total current assets |
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245,138 |
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254,380 |
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Net property, plant & equipment |
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2,670 |
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3,297 |
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Other assets |
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460 |
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460 |
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Total assets |
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$ |
248,268 |
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$ |
258,137 |
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Accounts payable |
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$ |
2,325 |
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$ |
3,515 |
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Accrued expenses and other short-term liabilities |
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15,130 |
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20,338 |
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Deferred revenues - short term |
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9,262 |
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9,104 |
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Total current liabilities |
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26,717 |
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32,957 |
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Deferred revenues - long term |
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48,376 |
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50,350 |
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Other long term liabilities |
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1,922 |
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2,033 |
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Total long term liabilities |
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50,298 |
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52,383 |
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Total stockholders equity |
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171,253 |
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172,797 |
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Total liabilities and stockholders equity |
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$ |
248,268 |
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$ |
258,137 |
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About Feraheme® (ferumoxytol)/Rienso
In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol received marketing approval in Canada in March 2012, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso®. For additional product information, please visit www.feraheme.com.
Feraheme ® (ferumoxytol) Injection for Intravenous (IV) 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.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Serious adverse reactions of clinically significant hypotension have been reported. In the post-marketing setting, life-threatening anaphylactic type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness and other safety events have been reported in patients being treated with Feraheme. In clinical trials, the most commonly occurring adverse reactions for Feraheme-treated patients were nausea, dizziness, hypotension, peripheral edema, headache, edema and vomiting. A full list of adverse events can be found in the full prescribing information for Feraheme.
For full prescribing information, please visit www.feraheme.com.
Forward-looking Statement
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 market for Feraheme and our future revenues and profitability; our operating expenses and cost of goods sold; expectations regarding the FDAs review of our sNDA for Feraheme; our expectations for revenue growth and the expanded indication for Feraheme; AMAGs pursuit of activities in preparation for the potential approval of our sNDA; the impact of 2012 changes to our business; our expected 2013 Feraheme product revenue; our expected 2013 operating expenses and cost of goods sold; our expected 2013 year-end cash and investments balance; potential Feraheme milestone or royalty payments; and our plans to expand the reach of Feraheme to new indications and geographic territories 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, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2012 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
AMAG PHARMACEUTICALS 1Q13 Financial Results April 23, 2013 |
FORWARD LOOKING STATEMENTS 2 This presentation 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: (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; (v) statements regarding our GI launch planning; (vi) statements regarding the potential size and expansion 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 IV 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 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, 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 significant safety or drug interaction problems 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 Annual Report on Form 10-K for the year ended December 31, 2012 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 |
AGENDA Topic Speaker Opening Remarks Bill Heiden, CEO Financial Highlights & Outlook Frank Thomas, COO Commercial Progress Greg Madison, CCO Expansion Opportunities and Closing Remarks Bill Heiden, CEO 3 |
FIRST QUARTER 2013 HIGHLIGHTS Strong financial performance 16% increase in total revenue vs. 1Q12 19% increase in U.S. Feraheme net sales driven by volume and net revenue per gram growth 24% decrease in operating expenses vs. 1Q12 Record non-dialysis provider demand 29,500 grams 11% increase, E.I. 110 vs. 1Q12 Very strong growth in hospital segment largest segment of non-dialysis IV iron market sNDA accepted for broad IDA indication; October 21, 2013 PDUFA Excellent progress preparing for the potential launch in the broader IDA indication New chief commercial officer, Greg Madison Extensive business development activities 4 |
FINANCIAL OVERVIEW Frank Thomas, Chief Operating Officer |
FERAHEME ON A SOLID GROWTH TRAJECTORY 6 *Excludes reduction of reserves for product returns and Medicaid in 2012 (in millions) +14% volume growth +5% price growth vs. 1Q2012 +17% volume growth -5% price decline vs. 2011 |
IMPROVED NET REVENUE PER GRAM Realizing benefit of price increases taken in 2012 Reversed historically deteriorating net revenue per gram in 2012 ASP for 2Q13 increased for third consecutive quarter 7 2013 2012 5% Net Revenue per Gram * Net price per gram is calculated by deducting estimated fees, discounts, rebates, and returns from the wholesale acquisition cost (list price) per gram of Feraheme. See AMAGs quarterly filings with the SEC for more information related to the Companys gross to net sales adjustment. |
FIRST QUARTER FINANCIAL HIGHLIGHTS ($ in millions, except per share ) 1Q13 1Q12 Growth Total Revenues $17.9 $15.5 16% Net Feraheme US Product Revenues $15.6 $13.1* 19% Feraheme Gross Margin % of product sales $12.8 82% $10.5* 77% 23% R&D Expenses $5.4 $12.5 (57%) SG&A Expenses $14.0 $13.2 5% Net Loss ($3.9) ($12.4) (69%) Loss Per Basic Share ($0.18) ($0.58) (69%) Cash and investments $217.1 $217.9 (<1%) 8 *Excludes $0.5 million reduction of reserves for product returns |
2013 FINANCIAL OUTLOOK 9 Expenses (in millions) Total Revenues of $73 - $77 million $63 $67 million in U.S. Feraheme net sales Operating expenses of $78 $82 million (excluding COGS) COGS: 14%-18% of global Feraheme sales End 2013 with $206 $211 million of cash and investments, not including the impact of business development transactions 2013 Guidance Reiterated Revenues (in millions) |
FERAHEME PERFORMANCE Greg Madison, Chief Commercial Officer |
IV IRON NON-DIALYSIS MARKET DYNAMICS 11 IV iron market flat year over year Shifting practice patterns beginning to emerge Hospitals acquiring hem/onc practices HOPPS changes; Feraheme continues to be fully reimbursed Source: IMS Health Data. |
1Q13 RECORD FERAHEME NON-DIALYSIS PROVIDER DEMAND 12 Source: IMS Health Data. 11% Grams 1Q13 Results 11% increase in Feraheme provider demand; 110 evolution index 24% growth in hospital 14% share of non-dialysis IV iron market 26% of hem/onc segment; e.i. 104 9% of hospital segment; e.i. 123 40% of nephrology segment |
Targeting accounts, with differentiated strategy, message and tactics Tracking progress against growth & volume goals across all segments STRATEGIES DRIVING DOUBLE-DIGIT VOLUME GROWTH 13 |
U.S. BROAD IDA IV IRON MARKET OPPORTUNITY TODAY Current Feraheme Opportunity 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. Current CKD market opportunity of ~$200 million CKD market expansion could drive additional growth Opportunity doubles to ~$400 million adding broad IDA patients currently treated with IV iron Significant market expansion potential with broad label 14 Expanded Label Opportunity (sNDA submitted December 2012) |
IV IRON REFERRALS - TODAY 15 Patients with Iron deficiency anemia IV iron Fail or intolerant Oral Iron IBD, Celiac, bariatric surgery Gastroenterology Abnormal Uterine Bleeding OB/GYN Crohns, arthritis Rheumatology CHF Cardiology Non - dialysis CKD Nephrology IV Iron Administration Hematologist /Oncologist Hospital outpatient Infusion Center Hospital In - patient |
IV IRON REFERRALS - 16 Patients with Iron deficiency anemia Fail or intolerant Oral Iron IV iron TOMORROW IBD, Celiac, bariatric surgery Gastroenterology Abnormal Uterine Bleeding OB/GYN Crohns , arthritis Rheumatology CHF Cardiology Non - dialysis CKD Nephrology INCREASE THE RATE OF ORAL IRON FAILURE PATIENTS THAT ARE REFERRED FOR IV IRON TREATMENT IV Iron Administration Hematologist /Oncologist Hospital outpatient Infusion Center Hospital In - patient |
GASTROENTEROLOGY A PRIME OPPORTUNITY UPON APPROVAL 17 Causes of IDA Chronic GI disorders Inflammatory bowel disease >150,000 with IDA Bleeds of unknown origin Malabsorption disorders Celiac disease Bariatric surgery patients >150,000 with IDA Cannot tolerate or absorb oral iron Chronically iron deficient Relatively small specialty; easily targeted 13,000 GI specialists 150 Hospital-based IBD Centers 570 CMS-approved bariatric surgery centers Recognize anemia as an issue in their patients Have a high level of concern about the impact of anemia on their patients lives Treat IDA today Minority with IV iron Majority unaware of Feraheme Patient Characteristics Physician Characteristics |
GI LAUNCH PLANNING Developing launch strategies and tactics Market research Advisory boards Meet with key opinion leaders in the treatment of IBD and bariatric surgeons who are thought leaders in IDA Meet with advocacy groups to understand the community Develop reimbursement support documentation Educate Present GI-specific data at key GI medical meetings (DDW, ACG) Publish GI-specific data in peer-reviewed journals 18 |
BUILDING DISEASE STATE AWARENESS IRON MATTERS 19 |
I refused to continue to feel like the walking dead so I took matters into my own hands. Now that my iron deficiency has been corrected, I am a different person. I am more active with my children and am not dreading the next decade of my life Im embracing it. THE UNMET NEED THAT EXISTS WITH IDA 20 : : Patient 42, breast cancer patient Symptoms After undergoing treatment for breast cancer, experienced extreme fatigue. Diagnosis Iron deficiency anemia diagnosed by oncologist; as IDA progressed post-cancer treatment, cared for by OB/Gyn Treatment/ progression Prescription oral iron three times a day; eating iron-rich foods. She had a very hard time tolerating the oral iron and often gave up. The answer Visit to a hematologist who put together a plan tailored to Flora that corrected her iron deficiency. |
EXPANSION OPPORTUNITIES |
BUSINESS DEVELOPMENT TARGET CATEGORIES Bulls-Eye Hem/onc or hospital company or product $10-60 MM / yr. revenues 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 22 |
BUILDING OFF 1Q SUCCESS IN 2013 Achieve full year double-digit growth of Feraheme in CKD patient population Continue to realize increasing net revenue per gram of Feraheme sNDA Formal acceptance by FDA 1Q13 Planned approval & launch 4Q13 Pre-launch activities for potential broader IDA indication Execute one or more business development transaction(s) Deliver on financial guidance 23 |
AMAG PHARMACEUTICALS Well positioned for growth in 2013 and beyond |
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