Basis of Presentation and Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2012

Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation and Summary of Significant Accounting Policies

B.Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of the financial position and results of operations of the Company for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America.

In accordance with accounting principles generally accepted in the United States of America for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, or SEC, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2011. Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2011.

Use of Estimates and Assumptions

The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significant estimates and assumptions are used in, but are not limited to, revenue recognition related to product sales and collaboration agreements, product sales allowances and accruals, assessing investments for potential other-than-temporary impairment, estimates used to measure the fair value of our held for sale assets, and determining values of investments, reserves for doubtful accounts, accrued expenses, reserves for legal matters, income taxes and equity-based compensation expense. Actual results could differ materially from those estimates.

During the three months ended September 30, 2012, we reduced our clinical trial accruals by approximately $1.2 million, primarily related to cost savings below the contracted rates passed on by a certain third-party service provider, which resulted in changes in our estimated clinical trial costs for Feraheme to treat IDA regardless of the underlying cause. This change in estimate had an impact of $0.06 per basic and diluted share for the three and nine months ended September 30, 2012.

Principles of Consolidation

The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries, Alamo Acquisition Sub, Inc., AMAG Europe Limited, and AMAG Securities Corporation. Alamo Acquisition Sub, Inc. was incorporated in Delaware in July 2011. AMAG Europe Limited was incorporated in October 2009 in London, England. AMAG Securities Corporation is a Massachusetts corporation which was incorporated in August 2007. All intercompany account balances and transactions between the companies have been eliminated.

Fair Value of Financial Instruments

Under current accounting standards, fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.

Current accounting guidance establishes a hierarchy used to categorize how fair value is measured and which is based on three levels of inputs, of which the first two are considered observable and the third unobservable, as follows:

Level 1 - Quoted prices in active markets for identical assets or liabilities.

Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Assets Measured at Fair Value on a Recurring Basis

We hold certain assets that are required to be measured at fair value on a recurring basis, including our cash equivalents and short- and long-term investments. The following tables represent the fair value hierarchy as of September 30, 2012 and December 31, 2011 for those assets that we measure at fair value on a recurring basis (in thousands):

	Fair Value Measurements at September 30, 2012 Using:
			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Money market funds	$	41,500	$	41,500	$	—	$	—
Corporate debt securities	104,787		—		104,787		—
U.S. treasury and government agency securities	56,662		—		56,662		—
Commercial paper	6,494		—		6,494		—
	$	209,443	$	41,500	$	167,943	$	—

	Fair Value Measurements at December 31, 2011 Using:
			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Money market funds	$	55,995	$	55,995	$	—	$	—
Corporate debt securities	94,626		—		94,626		—
U.S. treasury and government agency securities	48,086		—		48,086		—
Commercial paper	5,991		—		5,991		—
Auction rate securities	17,527		—		—		17,527
	$	222,225	$	55,995	$	148,703	$	17,527

With the exception of our money market funds and, previously, our auction rate securities, or ARS, which we sold in June 2012, and which were valued using Level 3 inputs, the fair value of our investments is primarily determined from independent pricing services which use Level 2 inputs to determine fair value. Independent pricing services normally derive security prices from recently reported trades for identical or similar securities, making adjustments based upon other significant observable market transactions. At the end of each reporting period, we perform quantitative and qualitative analyses of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analyses, we did not adjust or override any fair value measurements provided by our pricing services as of either September 30, 2012 or December 31, 2011. In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during the nine months ended September 30, 2012.

In June 2012, we sold our remaining ARS portfolio, with a par value of $19.8 million, for proceeds of $18.3 million.

The following table provides a rollforward of Level 3 assets for the nine months ended September 30, 2012 (in thousands):

	Nine Months Ended September 30, 2012
Balance at beginning of period	$	17,527
Transfers to Level 3	—
Total gains (losses) (realized or unrealized):
Included in earnings	(1,471		)
Included in other comprehensive income (loss)	2,373
Purchases, issuances, sales and settlements:
Purchases	—
Issuances	—
Sales	(18,329		)
Settlements	(100		)
Balance at end of period	$	—
The amount of total gains (losses) for the period included in earnings attributable to the change in unrealized gains (losses) relating to assets still held at end of period	$	—

Gains and losses (realized or unrealized) included in earnings in the table above are reported in other income (expense) in our condensed consolidated statement of operations.

Assets Held for Sale

During the quarter ended September 30, 2012, we determined that certain assets related to our Cambridge, Massachusetts manufacturing facility, including the related land, building and certain equipment, met the criteria established by current accounting guidance for classifying assets as held for sale. As a result we have reclassified these assets from property, plant and equipment to assets held for sale in our condensed consolidated balance sheet as of September 30, 2012. In anticipation of a future sale, we have valued these assets at the lower of their carrying amount or fair value less cost to sell to arrive at the estimated fair value of $2.3 million as of September 30, 2012. Prior to our determination that our Cambridge, Massachusetts manufacturing facility and related assets met the requirements to be classified as assets held for sale, we accelerated the depreciation on such assets to reflect our then estimated fair value. In doing so, we recorded $1.1 million and $1.4 million of accelerated depreciation in our condensed consolidated statements of operations for the three and nine months ended September 30, 2012, respectively. Upon determination that these assets met the criteria for held for sale, we recognized an impairment loss of $0.8 million to decrease the carrying value of the assets to our best estimate of fair value as of September 30, 2012. Of these $2.2 million of non-cash charges, we recorded $2.0 million in cost of product sales and $0.2 million in research and development expenses in our condensed consolidated statement of operations for the nine months ended September 30, 2012. The fair values of the land, building, and equipment were estimated using offers received from potential purchasers, real estate appraisals and other estimates from third-parties and accordingly, these assets have been classified as Level 3 assets.

Revenue Recognition

Net Product Sales

We recognize net product sales in accordance with current accounting guidance related to the recognition, presentation and disclosure of revenue in financial statements, which outlines the basic criteria that must be met to recognize revenue and provides guidance for disclosure of revenue in financial statements. In addition, we record all revenue for Feraheme sold to our licensees in deferred revenues in our condensed consolidated balance sheets. We will recognize revenues from product sales to our licensees, the related cost of goods sold, as well as any royalty revenues due from our licensees, in our condensed consolidated statement of operations at the time our licensees report to us that sales have been made or samples provided to its customers.

We record product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and other rebates, distributor, wholesaler and group purchasing organizations, or GPO, fees, and product returns as a reduction of revenue in our condensed consolidated statement of operations at the time product sales are recorded. Calculating these gross-to-net sales adjustments involves estimates and judgments based primarily on actual Feraheme sales data, forecasted customer buying patterns blended with historical experience of products similar to Feraheme sold by others, and other market research. In addition, we also monitor our distribution channel to determine whether additional allowances or accruals are required based on inventory in our sales channel. An analysis of our product sales allowances and accruals for the three and nine months ended September 30, 2012 and 2011 is as follows (in thousands):

	Three Months Ended September 30,
	2012			2011
Product sales allowances and accruals
Discounts and chargebacks	$	6,644		$	3,601
Government and other rebates	1,595			2,120
Medicaid rebate reserve adjustment	(861		)	(3,026		)
Returns	(1,122		)	354
Total provision for product sales allowances and accruals	$	6,256		$	3,049
Total gross product sales	$	22,432		$	18,851
Total provision for product sales allowances and accruals as a percent of total gross product sales	28		%	16		%

	Nine Months Ended September 30,
	2012			2011
Product sales allowances and accruals
Discounts and chargebacks	$	19,382		$	9,400
Government and other rebates	4,487			6,897
Medicaid rebate reserve adjustment	(621		)	(2,532		)
Returns	(1,680		)	1,022
Total provision for product sales allowances and accruals	$	21,568		$	14,787
Total gross product sales	$	65,872		$	54,692
Total provision for product sales allowances and accruals as a percent of total gross product sales	33		%	27		%

Product sales allowances and accruals are primarily comprised of both direct and indirect fees, discounts and rebates and provisions for estimated product returns. Direct fees, discounts and rebates are contractual fees and price adjustments payable to wholesalers, specialty distributors and other customers that purchase products directly from us. Indirect fees, discounts and rebates are contractual price adjustments payable to healthcare providers and organizations, such as certain physicians, clinics, hospitals, GPOs, and dialysis organizations that typically do not purchase products directly from us but rather from wholesalers and specialty distributors. In accordance with guidance related to accounting for fees and consideration given by a vendor to a customer, including a reseller of a vendor’s products, these fees, discounts and rebates are presumed to be a reduction of the selling price of Feraheme. Product sales allowances and accruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and regulations) related to the purchase and/or utilization of the product by these entities and are recorded in the same period that the related revenue is recognized. We estimate product sales allowances and accruals using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates, contract performance by the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of Feraheme and other products similar to Feraheme, specific known market events and trends such as competitive pricing and new product introductions and current and forecasted customer buying patterns and inventory levels, and the shelf life of Feraheme. As part of this evaluation, we also review changes to federal and other legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Although allowances and accruals are recorded at the time of product sale, certain rebates are typically paid out, on average, up to six months or longer after the sale.

As part of our sales allowances and accruals, we reserve for estimated Medicaid rebates associated with instances where Medicaid will act as the insurer and for which we are required to pay a statutory rebate to Medicaid. During the three months ended September 30, 2012 and 2011, we revised our estimated Medicaid reserve rate based on actual product-specific rebate claims received since the launch of Feraheme in July 2009, our expectations of state level activities, and estimated rebate claims not yet submitted, which resulted in a $0.9 million and $3.0 million reduction of our estimated Medicaid rebate reserve, respectively, related to prior period Feraheme sales. During the nine months ended September 30, 2012 and 2011, this revision to our estimated Medicaid reserve rate resulted in a $0.6 million and $2.5 million reduction of our estimated Medicaid rebate reserve, respectively, related to prior years Feraheme sales. These changes in estimates are reflected as an increase in our net product sales for the three and nine months ended September 30, 2012 and 2011 and resulted in reductions to our gross to net percentage in the respective periods. The reduction of our estimated Medicaid rebate reserve had an impact of $0.04 and $0.03 per basic and diluted share for the three and nine months ended September 30, 2012, respectively, and $0.14 per basic and diluted share for each of the three and nine months ended September 30, 2011. We regularly assess our Medicaid reserve balance and the rate at which we accrue for claims against product sales. If we determine in future periods that our actual rebate experience is not indicative of expected claims, if our actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust our current Medicaid accumulated reserve estimate, which would affect our earnings in the period of the adjustment and could be significant.

We generally offer our wholesalers, specialty distributors and other customers a limited right to return product purchased directly from us, principally based on the product’s expiration date which, once packaged, is currently four years in the U.S. Reserves for product returns for domestic sales are recorded in the period the related revenue is recognized, resulting in a reduction to product sales. Currently, sales to our licensees are recognized as revenue when product is sold to our licensees’ customers and therefore no return reserve is required at the time of sale to our licensees. We evaluate our estimated product returns rate each period based on the historical return patterns and known or expected changes in the marketplace. During the three and nine months ended September 30, 2012, we reduced our reserve for product returns by approximately $1.3 million and $2.1 million, respectively, primarily as a result of a lower expected rate of product returns based on our actual returns experience to date as well as the lapse of the product return period on certain manufactured Feraheme lots that carried a two year expiration. As a result, the product returns reserve applied to gross product sales for the three and nine months ended September 30, 2012 was ($1.1) million and ($1.7) million, respectively, as compared to $0.4 million and $1.0 million in the three and nine months ended September 30, 2011, respectively. The reduction of our estimated product returns reserve had an impact of $0.06 and $0.10 per basic and diluted share for the three and nine months ended September 30, 2012, respectively. If we determine in future periods that our actual returns experience is not indicative of expected returns or if other factors affect estimated returns rates, we may be required to adjust our current accumulated returns reserve estimate, which would affect our earnings in the period of the adjustment and could be significant.

Concentrations and Significant Customer Information

Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash, cash equivalents, investments, and accounts receivable. As of September 30, 2012, our cash, cash equivalents and investments amounted to approximately $210.8 million. We currently invest our excess cash primarily in U.S. government and agency money market funds, and investments in corporate debt securities, U.S. treasury and government agency securities, and commercial paper. As of September 30, 2012 we had approximately $41.5 million of our total $42.9 million cash and cash equivalents balance invested in institutional money market funds, of which $21.4 million was invested in a single fund, which is collateralized solely by U.S. treasury and government agency securities.

Our operations are located solely within the U.S. We are focused principally on developing, manufacturing, and commercializing Feraheme. We perform ongoing credit evaluations of our customers and generally do not require collateral. The following table sets forth customers who represented 10% or more of our total revenues for the nine months ended September 30, 2012 and 2011.

	Nine Months Ended September 30,
	2012		2011
AmerisourceBergen Drug Corporation	34	%	42	%
Takeda Pharmaceuticals Company Limited	31	%	13	%
McKesson Corporation	17	%	20	%
Cardinal Health, Inc.	11	%	12	%

In addition, approximately 33% of our end-user demand during the nine months ended September 30, 2012 was generated by members of a single GPO with which we have contracted. Revenues from customers outside of the U.S. amounted to approximately 32% and 15% of our total revenues for the nine months ended September 30, 2012 and 2011, respectively, and were principally related to collaboration revenue recognized in connection with our collaboration agreement with Takeda, which is based in Japan.

Other

During the three months ended September 30, 2012, we reduced our clinical trial accruals by approximately $0.3 million as the result of an error in estimated clinical trial costs, which should have been recognized during the three months ended June 30, 2012. We determined that this correction was not material to our results of operations or financial condition for the three months ended June 30, 2012 or September 30, 2012.