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): March 1, 2012
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 Exhibit 99.1 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 March 5, 2012, AMAG Pharmaceuticals, Inc., or the Company, issued a press release regarding its operating results and revenues for the quarter and year ended December 31, 2011 and its intention to hold a conference call to discuss the Companys financial results, business highlights and commercial and development programs. A copy of the Companys press release is furnished herewith as Exhibit 99.1.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On March 1, 2012, the Companys Board of Directors appointed Scott A. Holmes, age 37, currently the Companys Chief Accounting Officer, Vice President of Finance and Controller, to serve as the Companys principal financial officer, effective immediately. Mr. Holmes biographical information and compensation arrangements were previously disclosed in Item 5.02 of the Companys Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on December 22, 2011, and such information is hereby incorporated by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The Company hereby furnishes the following exhibit:
99.1 |
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Press Release dated March 5, 2012. |
99.2 |
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Copy of presentation slides of the Company during March 5, 2012 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/ Joseph L. Farmer |
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Joseph L. Farmer |
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Chief Administrative Officer |
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and General Counsel |
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Date: March 5, 2012 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
AMAG Announces Fourth Quarter and Year End 2011 Financial Results
LEXINGTON, MA (March 5, 2012) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2011. As of December 31, 2011, the companys cash, cash equivalents and investments totaled approximately $230 million.
Business Update
· Total revenues for the year ended December 31, 2011 were $61.2 million, of which $52.1 million were net product revenues from Feraheme® (ferumoxytol) Injection for intravenous (IV) use. Feraheme net product revenues for the year included a $3.0 million favorable change in estimated Medicaid reserves to reflect AMAGs actual claims experience since launch, which the company recognized in the third quarter of 2011. For the fourth quarter, total revenues were $14.9 million, of which $12.8 million were Feraheme net product revenues.
· Total Feraheme provider demand for 2011 was approximately 92,000 grams(1), nearly all of which was for use in the non-dialysis setting for patients with chronic kidney disease (CKD), representing a 38% increase in non-dialysis provider demand over 2010. Feraheme non-dialysis provider demand for the fourth quarter of 2011 was approximately 16% percent higher than the fourth quarter of 2010.
· AMAG is continuing to work with Jefferies & Company, Inc. to identify and evaluate various strategies to enhance stockholder value, including a potential sale of the company, and leverage AMAGs core assets Feraheme, AMAGs commercial and drug development infrastructure, and the companys cash balance.
We are pleased with the progress that we are making in the strategic evaluation of our business and in our efforts to re-establish the growth of Feraheme in 2012, said Frank Thomas, chief operating officer and interim chief executive officer of AMAG. As we work to enhance value for our stockholders, we must grow our top line while operating as a leaner, more nimble organization to preserve our financial strength. We believe that the key commercial initiatives being implemented by a new leadership team, coupled with the discipline to manage our business to cash flow breakeven this year, will position us for success on both fronts in 2012.
Fourth Quarter and Full Year 2011 Financial Results (unaudited)
Total revenues for the quarter ended December 31, 2011 were $14.9 million as compared to $17.2 million for the same period in 2010. Total revenues for the year ended December 31, 2011 were $61.2 million as compared to $66.2 million for the same period in 2010. The decreases in revenues in 2011 over the comparable 2010 periods were primarily attributable to the decline in the companys revenues from dialysis organizations largely as a result of the January 1, 2011 implementation of the new Medicare prospective payment system for end-stage renal disease patients, also known as the bundle, offset, in part, by a $3.0 million favorable change in estimated Medicaid reserves.
Total operating costs and expenses for the quarter ended December 31, 2011 were $34.4 million as compared to $37.4 million for the same period in 2010. Total operating costs and expenses for the year ended December 31, 2011 were $141.0 million as compared to $149.2 million for the same period in 2010. The decrease in operating costs and expenses in 2011 versus 2010 was primarily due to a $16.1 million decrease in selling, general and administrative expenses, partially offset by increases in costs of goods sold and research and development expenses associated with the companys global IDA registration clinical program.
The company reported a net loss of $18.6 million, or a loss of $0.87 per share, for the quarter ended December 31, 2011, as compared to a net loss of $19.8 million, or a loss of $0.94 per share, for the same period in 2010. Net loss for the year ended December 31, 2011 was $77.1 million, or a loss of $3.64 per share, as compared to a net loss of $81.2 million, or a loss of $3.90 per share for the same period in 2010.
2012 Goals
AMAG expects to achieve the following in 2012:
· Increase the demand for Feraheme by >15%, as measured by grams sold through to non-dialysis sites of care for U.S. CKD patients, assuming a consistent growth rate for the overall IV iron market, continued Feraheme market share growth in the hematology/oncology and hospital segments, and maintenance of Ferahemes position as a market share leader in the non-dialysis nephrology segment;
· Receive a favorable decision on the companys marketing authorization application for Feraheme for the treatment of IDA in adult patients with CKD in Europe;
· Launch Feraheme, through our partner Takeda, in Europe and Canada; and
· File the sNDA in the United States for Feraheme for the broad iron deficiency anemia indication.
2012 Financial Guidance
The company reiterates its financial guidance to manage the business to achieve cash flow breakeven in 2012 based on the following guidance:
· Net Feraheme product revenues of $53 $57 million based on the commercial goals outlined above, excluding any royalties from sales outside the U.S.;
· Milestones received totaling $33 million associated with potential regulatory approvals and commercial launches in the EU and Canada;
· Cost of goods sold (COGS) of approximately 14% 18% of total product sales;
· Total operating expenses, excluding COGS, of $90 $95 million, of which $40 $45 million are expected to be research and development expenses and $50 $55 million are expected to be selling, general and administrative expense; and
· A 2012 year-end cash and investments balance of $225 $230 million.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides today at 4:30 pm E.T. to discuss the companys financial results, business highlights and commercial and development programs.
To access the conference call via telephone, dial (877) 412-6083 from the United States or (702) 495-1202 for international access. The pass code for the live call is 56349072.
The call will be webcast live with slides and accessible through the Investors section of the Companys website at www.amagpharma.com on March 5, 2012 at 4:30 pm E.T. Following the conference call, the webcast replay will be available at approximately 8:30 pm and will be archived on the AMAG Pharmaceuticals, Inc. website until April 5, 2012. The pass code for the replay is 56349072.
About Feraheme
In the United States, Feraheme® (ferumoxytol) Injection for intravenous use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease 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.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia. AMAG manufactures and sells Feraheme® (ferumoxytol) Injection for intravenous use.
For additional company or product information, please visit www.amagpharma.com or http://feraheme.com.
AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited, amounts in thousands, except for per share data)
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Three Months Ended Dec. 31, |
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Twelve Months Ended Dec. 31, |
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2011 |
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2010 |
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2011 |
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2010 |
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Revenues: |
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Product sales, net |
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$ |
12,908 |
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$ |
15,284 |
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$ |
52,813 |
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$ |
59,978 |
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License fee, collaboration and royalty revenues |
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1,999 |
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1,936 |
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8,436 |
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6,267 |
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Total revenues |
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14,907 |
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17,220 |
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61,249 |
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66,245 |
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Operating costs and expenses (1): |
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Cost of product sales |
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2,739 |
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2,438 |
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10,531 |
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7,606 |
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Research and development expenses |
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12,985 |
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13,279 |
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58,140 |
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54,462 |
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Selling, general and administrative expenses |
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15,173 |
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19,493 |
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68,863 |
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84,939 |
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Restructuring expenses |
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3,508 |
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2,224 |
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3,508 |
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2,224 |
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Total operating costs and expenses |
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34,405 |
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37,434 |
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141,042 |
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149,231 |
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Operating Loss |
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(19,498 |
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(20,214 |
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(79,793 |
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(82,986 |
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Interest and dividend income, net |
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357 |
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418 |
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1,747 |
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1,741 |
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Other income (expense) |
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1 |
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6 |
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(193 |
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(380 |
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Net loss before income taxes |
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(19,140 |
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(19,790 |
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(78,239 |
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(81,625 |
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Income tax benefit |
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559 |
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10 |
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1,170 |
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472 |
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Net loss |
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$ |
(18,581 |
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$ |
(19,780 |
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$ |
(77,069 |
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$ |
(81,153 |
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Net loss per share - basic and diluted: |
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$ |
(0.87 |
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$ |
(0.94 |
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$ |
(3.64 |
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$ |
(3.90 |
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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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21,248 |
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21,123 |
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21,189 |
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20,806 |
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(1) Stock-based compensation included in operating costs and expenses: |
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Cost of product sales |
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$ |
133 |
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$ |
141 |
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$ |
616 |
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$ |
441 |
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Research and development |
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509 |
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812 |
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1,874 |
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3,508 |
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Selling, general and administrative |
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598 |
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2,834 |
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7,548 |
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10,574 |
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Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
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December 31, 2011 |
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December 31, 2010 |
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Cash and cash equivalents |
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$ |
63,474 |
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$ |
112,646 |
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Short-term investments |
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148,703 |
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147,619 |
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Accounts receivable |
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5,932 |
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5,785 |
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Inventories |
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15,206 |
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16,344 |
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Receivable from collaboration |
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428 |
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441 |
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Other current assets |
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6,288 |
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7,949 |
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Total current assets |
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240,031 |
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290,784 |
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Property, plant & equipment, net |
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9,206 |
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11,235 |
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Long-term investments |
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17,527 |
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33,597 |
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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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$ |
267,224 |
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$ |
336,076 |
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Accounts payable |
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$ |
3,732 |
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$ |
4,553 |
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Accrued expenses |
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28,916 |
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25,555 |
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Deferred revenues - short term |
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6,346 |
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6,603 |
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Total current liabilities |
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38,994 |
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36,711 |
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Deferred revenues - long term |
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45,196 |
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51,292 |
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Other long term liabilities |
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2,438 |
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2,787 |
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Total long term liabilities |
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47,634 |
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54,079 |
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Total stockholders equity |
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180,596 |
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245,286 |
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Total liabilities and stockholders equity |
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$ |
267,224 |
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$ |
336,076 |
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The important safety information below is based on the United States prescribing information.
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.
Warnings and precautions
Feraheme may cause life-threatening hypersensitivity reactions including anaphylaxis and/or anaphylactoid reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Patients should be observed for signs and symptoms of hypersensitivity for at least 60 minutes following each Feraheme injection and the drug should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Please monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in > 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic/anaphylactoid reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of 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: our plans to grow Feraheme revenues in 2012 and operate as a leaner, more nimble organization; our plan to achieve cash flow breakeven status in 2012; our plans regarding our strategic alternatives review process; our 2012 goals, including our expectation to increase Feraheme gram demand by greater than 15% in non-dialysis sites of care, our expectation to receive a favorable decision on our marketing authorization application for Feraheme in Europe; our plan and expected timing to launch Feraheme in Europe and Canada through Takeda, and our plan to and the expected timing of our sNDA filing in the U.S. for Feraheme for the broad iron deficiency anemia indication; statements regarding our 2012 financial guidance, including our expected 2012 net Feraheme product revenues, our expected 2012 operating expenses, including expected research and development and selling, general and administrative expenses, our expected cost of goods sold, and our expected 2012 year-end cash and investments balance; and any potential Feraheme regulatory approvals and subsequent commercial launches in the EU and Canada and any potential milestone payments associated therewith, 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 ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in the broader IDA indication and in territories outside of the U.S., including the European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme, (5) uncertainties relating to our patents and proprietary rights, (6) uncertainties regarding the outcome of our evaluation of strategic alternatives, including the risk that the process will not result in a transaction,
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, 2010 and our Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2011. 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.
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
(1)IMS Health Monthly data.
AMAG Pharmaceuticals, Inc. Contacts
Investors: Amy Sullivan, 617-498-3303
Media: Lynn Blenkhorn, Feinstein Kean Healthcare, 508-851-0930, Lynn.blenkhorn@fkhealth.com
Exhibit 99.2
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2011 Financial Results Call March 5, 2012 |
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Forward Looking Statements 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: our statement that Feraheme has significant revenue growth potential through geographic and label expansion, our plans to grow Feraheme revenues in 2012;our plan to achieve cash flow breakeven status in 2012; our plans regarding our strategic alternatives review process; our 2012 goals, including our expectation to increase Feraheme gram demand by greater than 15% in non-dialysis sites of care, our expectation to receive a favorable decision on our marketing authorization application for Feraheme in Europe in the CKD indication; our plan and expected timing to launch Feraheme in Europe and Canada in the CKD indication in 2012, and our plan to and the expected timing of our sNDA filing in the U.S. for Feraheme for the broad iron deficiency anemia indication; statements regarding our 2012 financial guidance, including our expected 2012 net Feraheme product revenues, our expected 2012 operating expenses, including expected research and development and selling, general and administrative expenses, our expected cost of goods sold, and our expected 2012 year-end cash and investments balance; and statements regarding potential Feraheme regulatory approvals and subsequent commercial launches in the EU and Canada and any potential milestone payments associated therewith, 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 ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in the broader IDA indication and in territories outside of the U.S., including the European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme,(5) uncertainties relating to our patents and proprietary rights, (6)uncertainties regarding the outcome of our evaluation of strategic alternatives, including the risk that the process will not result in a transaction, 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, 2010 and our Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2011. 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. 1 |
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Agenda 2 Topic Speaker Overview Frank Thomas, COO and interim CEO Commercial Progress John Tucker, VP Commercial Operations Growth Opportunities, Financial Overview and Closing Remarks Frank Thomas Q&A All |
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Overview 3 |
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3Q11: FDA harmonizes most IV iron labels to contain 30-minute observation periods post-dosing Proposed merger with Allos did not receive the required votes by AMAG stockholders 1Q11: CMS implements bundle for dialysis patients; erodes significant portion of AMAG revenue AMAG sales force realigned to focus exclusively on non-dialysis CKD market Targets high volume CKD sites of care 1Q11 2Q11 3Q11 4Q11 2Q11: Feraheme® label reverts back to original 30-minute observation post dosing Feraheme gains market share in hospitals and hematology/ oncology clinics 4Q11: Restructured business; changed leadership; realigned sales force Retained Jefferies to explore strategic alternatives Feraheme approved in Canada Replaced dialysis revenues Enrollment in broad phase 3 IDA program nearly complete; completed in January 2012 AMAG: A Review of 2011 0 |
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Leveraging Core Assets to Create Long-term Stockholder Value AMAGs Key Assets Strong balance sheet, with approximately $230 million in cash and no debt Feraheme, an approved product in the U.S. and Canada, that generates more than $50 million a year in U.S. revenues Focused U.S. commercial footprint on key accounts within hematology/oncology, nephrology and hospital segments Strong ex-U.S. partnerships Significant revenue growth potential through geographic and label expansion Strategic Review Process Working with financial advisors to evaluate all strategic options to enhance stockholder value and leverage AMAGs core assets Managing expenses to ensure our balance sheet remains strong to allow us to thoroughly evaluate the various options 5 |
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Commercial Progress 6 |
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7 Feraheme Strong Momentum in Non-Dialysis CKD Market -Historic results based on IMS Monthly Data, IMS Weekly Data and Wholesaler Shipment Data. Feraheme Grams ~40% Growth in Feraheme Provider Demand from 2010 - 2011 >15% Growth in Feraheme Provider Demand Estimated from 2011 - 2012 |
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Feraheme Non-Dialysis CKD Provider Demand 8 Feraheme Grams Source: IMS monthly data and wholesaler shipment data for 1/29/12 2/25/12. |
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Non-Dialysis IV Iron Market: 3 Major Sites of Administration/Influence for CKD Patients Multiple sites of care Formulary drives access IV Iron Grams in Segment: ~513,0001 Estimated % of Total IV Use: ~65%1 Limited IV iron use Generally more conservative IV Iron Grams in Segment: ~24,0001 Estimated % of Total IV Use: ~3%1 Generally take more aggressive approach to IDA management Anemia management referral site by many specialties (regardless of underlying cause) IV Iron Grams in Segment: ~206,0001 Estimated % of Total IV Use: ~26%1 IMS Monthly DDD through November 30, 2011. IMS Weekly, December 2011. Based on grams. 9 |
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Critical Commercial Success Factors in 2012 Implementing targeted account call plan for sales representatives focused on: Driving share in hospitals with large infusion clinics and outpatient formularies where large numbers of CKD patients are treated utilizing contracting and physician relationships Increasing share in large hematology/oncology clinics that have limited use of Feraheme and opening new hematology/oncology accounts where large numbers of CKD patients are treated Targeting nephrologists with infusion clinics and ability to influence hospital P&Ts and usage Develop Feraheme segmentation messaging and patient profiling for all target audiences Stress the Feraheme efficacy story on every interaction with health care providers and develop tools to emphasize the Feraheme efficacy story Leverage relationships with hematology/oncology GPOs to drive access in hard to see accounts and build awareness of Feraheme and the prevalence of CKD in IDA patients Establish pricing strategies to improve net effective price per gram 10 |
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Feraheme Growth Opportunities and Financial Overview 11 |
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Feraheme Provides Solid Foundation for Growth 12 Growth Initiatives US CKD Market Current market share of non-dialysis market has grown to 12% Market share growth achieved in 2011 Hem/Onc - 20% to 24% Hospital - 6% to 7% Nephrology share exited 2011 at 44% Segment specific initiatives should drive incremental growth in 2012 Global Expansion EU CKD approval and launch expected in 2012 Canadian CKD approval in 2011, with launch in 2012 $33 million in milestones expected in 2012 Takeda has commercial rights in these regions Broad IDA Opportunity Completed enrollment in Jan 2012 U.S. sNDA filing targeted for 2H2012 Commercialization planning underway for various specialties (Gastro, Oncology, OB/GYN) Broad IDA approval in EU results in a significant milestone payment |
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Financial Highlights Year Ended ($ in millions, except per share ) Q4-2011 Q4-2010 2011 2010 Total Revenues $14.9 $17.2 $61.2 $66.2 Net Product Revenues 12.9 15.3 52.8* 60.0 Cost of Product Sales 2.7 2.4 10.5 7.6 R&D Expenses 13.0 13.3 58.1 54.5 SG&A Expenses 15.2 19.5 68.9 84.9 Net Loss (18.6) (19.8) (78.2) (81.2) Loss Per Share (0.87) (0.94) (3.64) (3.90) 13 Balance Sheet Ended 2011 with $229.7 million in cash and investments Results of operations (2011 vs. 2010) 38% growth in demand of Feraheme in non-dialysis setting Operating expenses down 8% $64.2 million cash used to support operations in 2011 *Includes $3.0 million reversal in Medicaid reserves in the third quarter of 2011. |
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Strong Financial Profile 14 GAAP Revenue Operating Expenses (excluding COGS) ($ in millions) ($ in millions) $53 $57 million in Feraheme net product revenue >15% growth in grams $33 million of cash milestones received COGS assumed to be 14-18% of net product sales $90 $95 million in total operating expenses $40 $45 million in R&D $50 $55 million in SG&A Committed to managing business to cash flow breakeven End 2012 with $225 $230 million 2012 Financial Outlook *Represents $3.0 million reversal in Medicaid reserves in the third quarter of 2011. |
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Multiple 2012 Milestones Provide Growth Opportunities Clinical and regulatory Complete enrollment of broad IDA phase 3 registration program Regulatory decisions in international markets on CKD filings Present/publish IDA program data Submit sNDA in US for broad IDA indication Commercial and business Complete strategic alternatives process Support international launches of Feraheme in Europe and Canada Deliver on financial guidance for 2012 15 |
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Q&A 16 INVESTOR RELATIONS CONTACT: 617-498-3303 |
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