AMAG Pharmaceuticals, Inc.
Annual Report 2009

Plain-text annual report

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549FORM 10-KCommission file number 0-14732AMAG Pharmaceuticals, Inc.(Exact Name of Registrant as Specified in Its Charter)Delaware(State or Other Jurisdiction ofIncorporation or Organization) 04-2742593(I.R.S. EmployerIdentification No.)100 Hayden AvenueLexington, Massachusetts(Address of Principal ExecutiveOffices) 02421(Zip Code)(617) 498-3300(Registrant's Telephone Number, Including Area Code)Securities registered pursuant to Section 12(b) of the Act: Common Stock, par value $0.01 per share, NASDAQ Global MarketSecurities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes  No oo Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes oo No  Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to suchfiling requirements for the past 90 days. Yes  No oo(Mark One)  ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACTOF 1934For the Fiscal Year Ended December 31, 2009oro TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGEACT OF 1934For the transition period from to  Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data Filerequired to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes oo No oo Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained,to the best of the registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or anyamendment to this Form 10-K o Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reportingcompany. See definition of "accelerated filer," "large accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Checkone): Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No  The aggregate market value of the registrant's voting stock held by non-affiliates as of June 30, 2009 was approximately $930,000,000 based onthe closing price of $54.67 of the Common Stock of the registrant as reported on the NASDAQ Global Market on such date. As of February 16, 2010,there were 20,987,794 shares of the registrant's Common Stock, par value $0.01 per share, outstanding.DOCUMENTS INCORPORATED BY REFERENCE Portions of the Proxy Statement to be filed in connection with the solicitation of proxies for the Annual Meeting of Stockholders to be held onMay 25, 2010, are incorporated by reference into Part III of this Annual Report on Form 10-K.Large accelerated filer  Accelerated filer o Non-accelerated filer o(Do not check if asmaller reporting company) Smaller reporting company oTable of ContentsAMAG PHARMACEUTICALS, INC.FORM 10-KFOR THE YEAR ENDED DECEMBER 31, 2009TABLE OF CONTENTSPART I Item 1. Business 1Item 1A. Risk Factors 23Item 1B. Unresolved Staff Comments 44Item 2. Properties 44Item 3. Legal Proceedings 44Item 4. Submission of Matters to a Vote of Security Holders 44PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity Securities 45Item 6. Selected Financial Data 46Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 47Item 7A. Quantitative and Qualitative Disclosures About Market Risk 73Item 8. Financial Statements and Supplementary Data 74Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 116Item 9A. Controls and Procedures 116Item 9B. Other Information 117PART III Item 10. Directors, Executive Officers and Corporate Governance 118Item 11. Executive Compensation 118Item 12. Security Ownership of Certain Beneficial Owners and Management and Related StockholderMatters 118Item 13. Certain Relationships and Related Transactions and Director Independence 118Item 14. Principal Accountant Fees and Services 118PART IV Item 15. Exhibits and Financial Statement Schedules 119Table of ContentsPART I Except for the historical information contained herein, the matters discussed in this Annual Report on Form 10-K may be deemed to be forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995 and other federal securities laws. In this Annual Report on Form 10-K, words such as "may," "will," "expect,""intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended toidentify forward-looking statements. Examples of forward looking statements contained in this report include statements regarding the following: ourexpectations regarding our intended development and commercialization of Feraheme® (ferumoxytol) Injection, our expectation that utilization ofpreviously deferred Feraheme Launch Incentive Program revenues will increase, the expected timing of the filing of our marketing authorizationapplication for Feraheme with the European Medicines Agency, our plan to conduct two pediatric studies and the expected timing and design of thesestudies, our plan to conduct and the intended timing and design of our planned global studies of Feraheme for the treatment of iron deficiency anemiain a broad range of patients, our belief that all items or information requested in the Screening Deficiency Notice from Health Canada are readilyaddressable, our statement that our partner in China, 3SBio Inc., plans to conduct a Feraheme clinical study in China, our expectation that sales ofGastroMARK will not change materially, our expectation that we will not recognize any Feridex I.V. related revenues in 2010, our belief as to thepotential size of the non-dialysis chronic kidney disease market segment and current use of intravenous iron within that market segment, ourexpectation regarding our future revenues, including expected future Feraheme and 3SBio Inc. revenues and our expectation to partly fund our futureoperations with Feraheme revenues, our expectation that our costs of product sales will increase, our expectation that research and developmentexpenses will increase, our expectations regarding the amount of external expenses and the timing of our planned research and development projects,our expectation that selling, general and administrative expenses will increase, our expectation regarding our dividend and interest income, ourexpectation regarding our short- and long-term liquidity and capital requirements and our ability to finance our operations, our expectation regardingour future cash flows, our expectation that net cash used in operating activities will decrease in 2010, our belief that the impairment in the value of ourauction rate securities not subject to settlement right agreements is temporary and that we will ultimately be able to liquidate these investments withoutsignificant loss, our intention to sell our auction rate securities subject to settlement right agreements to UBS AG, and information with respect to anyother plans and strategies for our business. Our actual results and the timing of certain events may differ materially from the results discussed,projected, anticipated or indicated in any forward-looking statements. Any forward-looking statement should be considered in light of the factorsdiscussed in Part I, Item 1A below under "Risk Factors" and elsewhere in this Annual Report on Form 10-K. We caution readers not to place unduereliance on any such forward-looking statements, which speak only as of the date they are made. We disclaim any obligation, except as specificallyrequired by law and the rules of the United States Securities and Exchange Commission to publicly update or revise any such statements to reflect anychange in company expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect thelikelihood that actual results will differ from those set forth in the forward-looking statements.ITEM 1. BUSINESS: Company Overview AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company that utilizes our proprietarytechnology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid inthe diagnosis of cancer and cardiovascular disease. We currently manufacture and sell two approved products, Feraheme® (ferumoxytol) Injection forintravenous, or IV, use and GastroMARK®.1Table of Contents On June 30, 2009, Feraheme was approved for marketing in the U.S. by the U.S. Food and Drug Administration, or the FDA, for use as an IViron replacement therapy for the treatment of iron deficiency anemia, or IDA, in adult patients with chronic kidney disease, or CKD. We market and sellFeraheme through our own commercial organization, consisting of approximately 120 professionals, including an 80-person specialized sales force andaccount management and reimbursement teams. We sell Feraheme primarily to authorized wholesalers and specialty distributors and began commercialsale of Feraheme in the U.S. in July 2009. In November 2009, the Centers for Medicare & Medicaid Services, or CMS, assigned Feraheme two unique Q-codes, one for the treatment ofIDA in end-stage renal disease patients undergoing dialysis and one for the treatment of IDA in non-end-stage renal disease patients. These Q-codes,which are temporary product-specific codes that enable automated processing of Feraheme-related claims, became effective on January 1, 2010. For the year ended December 31, 2009, we recognized net product sales of Feraheme of $15.8 million, including approximately $1.3 million of the$11.5 million in deferred product revenues we had recorded in the third quarter of 2009. During the third quarter of 2009, shortly after the launch ofFeraheme, we implemented a Launch Incentive Program under which certain dialysis organizations purchased Feraheme directly from us. Thisprogram provided certain customers with, among other things, discounted pricing and expanded rights of return. As a result, we deferred revenuesassociated with this program which we will recognize as revenues as the participating organizations utilize their Feraheme inventory. We expect thatutilization of the remaining deferred product revenues from the Launch Incentive Program will increase going forward as each Launch IncentiveProgram customer has begun to use Feraheme. In December 2009, we submitted draft protocols for two proposed clinical trials to meet our FDA post-approval Pediatric Research Equity Actrequirement to support pediatric labeling of Feraheme. In 2010, we intend to initiate these two randomized, active controlled pediatric studies in childrenwith IDA. One study will be in dialysis dependent CKD patients, and the other will be in CKD patients not on dialysis. Each study will assess thesafety and efficacy of Feraheme treatment as compared to oral iron in approximately 144 children. We also plan to advance our Feraheme clinical development program in adults by initiating two Phase III multi-center clinical trials in mid-2010 toassess Feraheme for the treatment of IDA in a broad range of patients, which may include women with abnormal uterine bleeding, or AUB, patientswith cancer and gastrointestinal diseases and postpartum women, for whom oral iron is unsatisfactory. One study will assess the efficacy and safety oftwo doses of 510 milligrams each of Feraheme compared to placebo in a total of approximately 800 patients with IDA. A second study will assess theefficacy and safety of two doses of 510 milligrams each of Feraheme compared to a total dose of 1,000 milligrams of an IV iron sucrose product in atotal of approximately 600 patients with IDA. Further, we intend to initiate an open label extension study enrolling patients from the placebo controlledstudy who will be followed for six months and will be eligible to receive two doses of 510 milligrams each of Feraheme whenever they meet treatmentcriteria. We continue to evaluate our strategy for seeking approval for Feraheme as an IV iron replacement therapeutic agent in countries outside of theU.S. The commercial opportunity for Feraheme as an IV iron replacement therapeutic agent varies from country to country, and in determining whichadditional markets outside of the U.S. we intend to enter, we are assessing factors such as potential pricing and reimbursement, the role of iron inmedical treatment protocols, and the regulatory requirements of each country. We expect to file a Marketing Authorization Application, or MAA, forFeraheme for the treatment of IDA in CKD patients with the European Medicines Agency, or EMEA, in mid-2010. In the fourth quarter of 2009, wereceived approval from the EMEA for our Pediatric Investigation Plan, which is a prerequisite for the submission of our Feraheme MAA. OurPediatric Investigation Plan2Table of Contentsincludes the two pediatric studies required to meet our Pediatric Research Equity Act requirement and two additional pediatric studies requested by theEMEA. To further support our MAA, we have initiated a global, randomized, Phase IV multi-center, active controlled trial with approximately 150adult CKD patients both on dialysis and not on dialysis. This study will assess the safety and efficacy of two doses of 510 milligrams each of Ferahemecompared to a total dose of 1,000 milligrams of an IV iron sucrose product. In December 2009, we filed a New Drug Submission for Feraheme to treat IDA in patients with CKD with the Therapeutic Products Directorateof Health Canada, or Health Canada, the federal authority that regulates pharmaceutical drugs and medical devices for human use in Canada. InFebruary 2010, we received a Screening Deficiency Notice from Health Canada requesting certain clarifications and additional documents. We havesubmitted our response to Health Canada and believe that all of these items are readily addressable. In addition, in December 2009, our partner in China,3SBio Inc., or 3SBio, filed an application with the Chinese State Food and Drug Administration, or the SFDA, to obtain approval to begin aregistrational clinical trial necessary to file for marketing approval in China. Once approved by the SFDA, 3SBio plans to commence a multi-centerrandomized efficacy and safety study in China involving approximately 200 CKD patients. In addition to its use for the treatment of IDA, Feraheme may also be useful as a vascular enhancing agent in magnetic resonance imaging, orMRI. In August 2008, the FDA granted Fast Track designation to Feraheme with respect to its development as a diagnostic agent for vascular-enhanced MRI for the assessment of peripheral arterial disease, or PAD, in patients with CKD. We have enrolled over two-thirds of our 108 patientPhase II study of Feraheme in vascular-enhanced MRI for the detection of clinically significant arterial stenosis or occlusion, or narrowing or blockingof the arteries. GastroMARK, our oral contrast agent used for delineating the bowel in MRI, is approved and marketed in the U.S., Europe, and other countriesthrough our marketing partners. Sales of GastroMARK by our marketing partners have been at their current levels for the last several years, and we donot expect sales of GastroMARK to change materially. Feridex I.V.®, our liver contrast agent, had been marketed and sold in the U.S., Europe and other countries for a number of years through ourmarketing partners. In November 2008, we decided to cease manufacturing Feridex I.V. Accordingly, we have terminated all of our agreements with ourmarketing partners for Feridex I.V. throughout the world and do not intend to continue commercializing Feridex I.V. We recorded no product salesrevenues associated with Feridex I.V. in 2009 and do not expect to recognize any Feridex I.V. related revenues in 2010. In January 2010, we sold 3,600,000 shares of our common stock, $0.01 par value per share, in an underwritten public offering at a price to thepublic of $48.25 per common share, resulting in gross proceeds of approximately $173.7 million. Net proceeds to us after deducting fees, commissionsand other expenses related to the offering were approximately $165.6 million. The shares were issued pursuant to a shelf registration statement onForm S-3 which became effective upon filing. Our common stock trades on the NASDAQ Global Market, or NASDAQ, under the trading symbol "AMAG."Our Core Technology Our core technology is based on small, coated superparamagnetic iron oxide nanoparticles and their characteristic properties. Our corecompetencies include the ability to design such nanoparticles for particular applications, to manufacture the nanoparticles in controlled sizes, and tocover the nanoparticles with different coatings depending upon the application for which they will be used. Our technology and expertise enable us tosynthesize, sterilize and stabilize these iron oxide nanoparticles in3Table of Contentsa manner necessary for use in pharmaceutical products such as IV iron replacement therapeutics and MRI contrast agents. Our iron oxide nanoparticles are composed of bioavailable iron that is easily utilized by the body and incorporated into the body's iron stores. As aresult, products using our core technology are well suited for use as an IV iron replacement therapy. Additionally, the superparamagnetic characteristicof our products result in nanoparticles that become strongly magnetic when placed in a magnetic field, but lose their magnetism once the field isremoved. Therefore, use of our nanoparticles can result in MRIs that provide essential information to the reviewing physician. Our rights to ourtechnology are derived from and/or protected by license agreements, patents, patent applications and trade secret protections. See "Patents and TradeSecrets."Products The following table summarizes applications and potential applications of our products, the names of our principal marketing partners, the currentU.S. and foreign regulatory status and the primary markets for each of our products. For a discussion of the substantive regulatory requirements applicable to the development and regulatory approval process in the U.S. and othercountries, see "Government Regulation."4Product Applications Marketing Partners U.S. Status Foreign StatusFeraheme®(ferumoxytol)Injection IV iron replacementtherapeutic agent for thetreatment of IDA in adultpatients with CKD. 3SBio Inc. (China) Approved for commercialsale on June 30, 2009;commenced commerciallaunch in July 2009. 3SBio Inc. filed forregistrational trial with theChinese regulatory agencyin December 2009. New Drug Submission filedwith the Canadianregulatory agency inDecember 2009. ScreeningDeficiency Notice receivedand response filed inFebruary 2010. Marketing AuthorizationApplication planned to befiled with the EuropeanMedicines Agency in mid-2010. IV iron replacementtherapeutic agent inpatients with IDA,regardless of the underlyingcause. None Global Phase III programplanned to be initiated inmid-2010. No marketing applicationsfiled to date. Vascular-enhanced MRIagent for PAD. None Phase II clinical trial inprogress. No marketing applicationsfiled to date.GastroMARK® Delineating the bowel inabdominal imaging. Covidien, Ltd. (U.S.) andGuerbet, S.A. (variouscountries in the EuropeanUnion, South America, theMiddle East, southeastAsia, Africa and easternEurope) Approved and marketed. Approved and marketed inseveral European Unioncountries.Table of ContentsFeraheme as an IV Iron Replacement TherapeuticOverview On June 30, 2009, Feraheme was approved for marketing in the U.S. by the FDA for use as an IV iron replacement therapy for the treatment ofIDA in adult patients with CKD. In July 2009, we began to market and sell Feraheme in both the dialysis and non-dialysis CKD markets, including tonephrologists, hematologists, dialysis organizations, hospitals and other end-users who treat patients with CKD.Chronic kidney disease, anemia, and iron deficiency It has been estimated that approximately 10% to 15% of the U.S. adult population is affected by CKD, a condition generally characterized bydamaged kidneys, or a reduction in kidney function below 60% of normal. Anemia, a common condition among CKD patients, is associated withcardiovascular complications, decreased quality of life, hospitalizations, and increased mortality. Anemia develops early during the course of CKD andworsens with advancing kidney disease. Iron deficiency is a common cause of anemia in CKD patients and can result from multiple blood draws,hospitalizations and interventional procedures, gastrointestinal bleeding, or poor nutritional intake. Regardless of the cause of anemia, iron replacementtherapy is essential to increase iron stores and raise hemoglobin levels. Iron is also essential for effective treatment with erythropoiesis stimulatingagents, or ESAs, which are commonly used in anemic patients to stimulate red blood cell production. According to an estimate by the United States Renal Data System, approximately 400,000 CKD patients are projected to be on dialysis in the U.S.in 2010. Approximately 90% of these dialysis patients will receive IV iron as part of managing their anemia. In addition, data contained in a 2002publication in the Journal of the American Society of Nephrology suggests that up to 1.6 million of stage 3 and 4 non-dialysis CKD patients with anemiamay be iron deficient and could therefore benefit from receiving IV iron. We believe that less than 10% of these patients are currently being treated withIV iron. Currently there are two methods used to treat IDA in CKD patients: oral iron supplements and IV iron. Oral iron supplements are often notabsorbed well by the gastrointestinal tract and frequently have side effects, such as constipation, diarrhea, and cramping, which can cause patients tostop taking their medication. In addition, it can take an extended time for hemoglobin levels to improve following the initiation of oral iron treatment.Conversely, iron given intravenously allows larger amounts of iron to be provided to patients while avoiding many of the side effects and treatmentcompliance issues associated with oral iron, and can result in faster rises in hemoglobin levels. The administration of IV iron has been shown to beeffective in treating anemia either when used alone or in combination with an ESA. Current U.S. treatment guidelines indicate that treating first with ironalone may delay or reduce the need for ESA therapy. For IV iron replacement therapy in patients with CKD, the total therapeutic course of iron typically used in clinical practice is 1,000 milligrams, orone gram. Rapid administration of large doses of other IV iron products has been associated with an unfavorable safety profile. As a result, other IViron products are typically administered as a slow push or a 15 to 60 minute infusion in doses of 100 to 200 milligrams, thus requiring five to tenphysician visits and repeated IV access for patients to receive a standard one gram therapeutic course, potentially resulting in considerable burden toboth providers and patients. Feraheme is administered as a 510 milligram injection followed by a second 510 milligram injection three to eight dayslater, each of which can be administered in as fast as 17 seconds at a regular office visit or during dialysis treatment without the use of infusionequipment or prolonged medical intervention.5Table of ContentsFeraheme in indications other than CKD IDA is widely prevalent in many different patient populations, including women with AUB, patients with cancer and gastrointestinal diseases, andpostpartum women. We believe that the product characteristics of Feraheme support clinical development in these additional indications, and we arecurrently in the process of preparing for a global clinical development program for Feraheme in a broad range of patients with IDA, regardless of theunderlying cause. We intend to initiate our Phase III program for Feraheme in IDA in mid-2010. Included among the patient populations we are evaluating for additional indications for Feraheme are women with AUB and cancer patients. AUB is defined as chronic, heavy, or prolonged uterine bleeding that can result from multiple causes, including uterine abnormalities, blooddisorders, pregnancy, intrauterine devices, medications, and heavy menstrual bleeding. Both iron deficiency and IDA are commonly associated withAUB. The prevalence of anemia in AUB patients has been reported to range from 10% to 67%, and the prevalence of iron deficiency in AUB patientshas been reported to range from 20% to 50%, depending on patient age and diagnostic criteria. IDA in patients with AUB, regardless of the cause,requires treatment with iron supplementation, either by oral or IV administration. Anemia is also common in patients with cancer. Depending on the type of cancer, it has been estimated that between 30% and 90% of patients withcancer have anemia. Iron supplementation through both oral and IV administration has an important role in treating anemia in cancer patients. Whilethere may be some differences in the underlying causes of anemia and iron deficiency in cancer patients who are receiving chemotherapy and those whoare not, patients in both categories may develop absolute IDA due to blood loss and/or the inadequate intake or absorption of iron. Oral iron has beenused to treat IDA in cancer patients, but its efficacy is variable due to inconsistent bioavailability and absorption, the high incidence of gastrointestinalside effects, potential interactions with other treatments and patient noncompliance. IV iron has been shown in small clinical trials to be well tolerated inthe cancer patient population in both patients who are receiving chemotherapy and those who are not.Ferumoxytol as a Diagnostic Agent for Vascular Enhancement in MRI MRI is a non-invasive method used to visualize normal or abnormal anatomy or pathophysiology in patients in order to diagnose disease andinjury. Imaging agents or biomarkers play an important role in improving the quality of diagnostic images by increasing the contrast between differentinternal structures or types of tissues in various disease states. Ferumoxytol is currently in development as an agent for vascular-enhanced MRI because of its ability to increase the magnetic relaxivity of blood,resulting in MRIs with enhanced vascular contrast. When used with the appropriate pulse sequence, ferumoxytol may provide high-quality diagnosticimages. In addition to its superparamagnetic properties, ferumoxytol can be administered rapidly as an IV injection at a rate of up to one milliliter persecond. It also has a long blood half-life of approximately 15 hours, which may permit repeated imaging of the same or different body regions. Thesefeatures of ferumoxytol may make it useful as an MRI biomarker in vascular disorders. The initial focus of our clinical development of ferumoxytol as an imaging agent has been in patients with PAD for the detection of clinicallysignificant arterial stenosis or occlusion. PAD is a manifestation of atherosclerotic cardiovascular disease and can occur when plaque builds up on theinside wall of the arteries that carry blood from the heart to the head, internal organs and limbs causing the arteries to narrow, which can reduce or blockblood flow. Symptomatic PAD is associated with decreased quality of life, and whether symptomatic or asymptomatic, PAD is associated with anincreased risk of cardiovascular and cerebrovascular problems, and cardiovascular mortality.6Table of Contents The prevalence of PAD in the U.S. is estimated to be approximately 8 million adults, affecting up to 20% of individuals 65 years of age and older.The prevalence of PAD increases with age, diabetes, CKD, hypertension and smoking, as does the presence of known atherosclerosis in other parts ofthe body. In the U.S., cardiovascular disease is a common cause of morbidity and mortality, with a prevalence of approximately one in three adults.Additionally, cardiovascular disease is the leading cause of death, accounting for approximately 35% of all deaths in 2005. Both the diagnosis and clinical management of PAD and cardiovascular disease often require the accurate assessment of vascular anatomy, andtherefore, there is an important medical need for the availability of safe and effective techniques for invasive and/or non-invasive imaging modalities inthese patient populations. High-resolution imaging, including digital subtraction angiography, contrast-enhanced computed tomography, and contrast-enhanced magnetic resonance angiography all provide the depiction of vascular anatomy required for consideration of endovascular or surgicalintervention. However, there are important side effects of these techniques that seriously impact the appropriate evaluation of patients. There is a well-known risk of kidney damage associated with the administration of certain contrast agents for computed tomography, digital subtraction angiography,and X-ray angiography. Several currently approved contrast agents used for MRI in the U.S. are gadolinium-based and are associated with rare butsevere adverse events in patients with CKD. In September 2007, the FDA issued a "Black Box" warning for all gadolinium-based contrast agents incertain patients due to these agents' potential association with Nephrogenic Systemic Fibrosis, or NSF. NSF is a condition that so far has only occurredin patients with kidney disease. NSF can pose a serious and potentially fatal risk to patients with CKD, and the FDA has sought to limit the use ofcurrently available contrast agents in this patient population. Currently there is no effective treatment for NSF. Ferumoxytol is an iron-based agent with unique superparamagnetic properties that may be visualized by MRI. There are no iron-based PADcontrast agents currently approved for MRI in the U.S. The FDA has granted Fast Track designation to ferumoxytol for its development as a diagnosticagent for vascular-enhanced MRI to improve the assessment of suspected PAD in patients with known or suspected CKD. The Fast Track process isdesigned to facilitate the development and expedite the FDA's review of products and is intended to bring valuable treatments more quickly to patients inneed. We have enrolled approximately two-thirds of our 108 patient Phase II study of ferumoxytol for vascular-enhanced MRI for the detection ofclinically significant arterial stenosis or occlusion. We currently have exclusive world-wide rights to market and sell ferumoxytol as an imaging agent.Feridex I.V. Feridex I.V. was approved by the FDA in 1996 and by the Committee for Proprietary Medicinal Products in the European Union, or EU, in 1994.In November 2008, we decided to cease manufacturing Feridex I.V., and we do not intend to continue its commercialization. Accordingly, we haveterminated all of our agreements with our marketing partners for Feridex I.V. throughout the world. We did not record any product sales revenuesassociated with Feridex I.V. in 2009 and do not expect to recognize any Feridex I.V. related revenues in 2010.GastroMARK Images of organs and tissues in the abdomen using MRI without contrast agents can be difficult to read because the abdominal organs and tissuescannot be easily distinguished from the loops of the bowel. GastroMARK, our oral contrast agent for delineation of the bowel, flows through anddarkens the bowel when ingested. By more clearly identifying the intestinal loops, GastroMARK enhances the ability to distinguish the bowel fromadjacent tissues and organs in the upper gastrointestinal tract. Sales of GastroMARK by our marketing partners have been at their current levels for thelast several years, and we do not expect sales of GastroMARK to materially increase.7Table of Contents GastroMARK was approved by the FDA in 1996. Our marketing partner, Covidien, Ltd., or Covidien, or its predecessors, have been marketingGastroMARK in the U.S. since 1997. We initially licensed the marketing rights to GastroMARK on an exclusive basis to Guerbet S.A., or Guerbet, inwestern Europe and Brazil. Guerbet has been marketing GastroMARK in several EU countries since 1993 under the tradename Lumirem® andsubsequently acquired the rights to market GastroMARK in several other countries in South America, the Middle East, southeast Asia, Africa, andeastern Europe. See "Licensing, Marketing and Supply Arrangements."Licensing, Marketing and Supply Arrangements Although we are commercializing Feraheme through our own commercial organization, our commercial strategy has also included the formation ofalliances with other pharmaceutical companies to facilitate the sale and distribution of our products. At present we are parties to the followingcollaborations:3SBio In May 2008, we entered into a Collaboration and Exclusive License Agreement, or the 3SBio License Agreement, and a Supply Agreement, orthe 3SBio Supply Agreement, with 3SBio with respect to the development and commercialization of Feraheme as an IV iron replacement therapeuticagent in China. The 3SBio License Agreement grants 3SBio an exclusive license for an initial term of thirteen years to develop and commercializeFeraheme as a therapeutic agent in China for an initial indication for the treatment of IDA in patients with CKD, and an option to expand into additionaltherapeutic indications. In consideration of the grant of the license, we received an up-front payment of $1 million. We are eligible to receive certainother specified milestone payments upon regulatory approval of Feraheme in China for CKD and other indications. We are also entitled to receive tieredroyalties of up to 25% based on sales of Feraheme by 3SBio in China. We retained all manufacturing rights for Feraheme. In addition, pursuant to the3SBio Supply Agreement, 3SBio has agreed to purchase from us, and we have agreed to supply to 3SBio, Feraheme at a predetermined supply pricefor clinical and commercial use in connection with 3SBio's development and commercialization obligations described above for so long as the 3SBioLicense Agreement is in effect.Guerbet In 1989, we entered into a supply and distribution agreement with Guerbet granting Guerbet an exclusive right to manufacture and sellGastroMARK in western Europe and Brazil (under the tradename Lumirem®) and the option to acquire rights to any future MRI contrast agentsdeveloped by us. This agreement was amended in 2002 to expand Guerbet's exclusive rights to manufacture and sell GastroMARK in various otherareas, including South America, the Middle East, southeast Asia, and eastern Europe. In 2004, it was determined through binding arbitration thatGuerbet failed to meet its contractual obligations with respect to the exercise of its option to acquire certain rights to Feraheme in imaging, and,accordingly, all such rights reverted back to us. Under the terms of this distribution agreement, Guerbet has agreed to pay us, as the purchase price forthe active ingredient of the licensed products, royalties and a percentage of net sales of the licensed products. We are required to sell to Guerbet itsrequirements for the active ingredient used in GastroMARK. The agreement is perpetual but terminable upon certain specified events.Covidien In 1990, we entered into a manufacturing and distribution agreement with Covidien's predecessor granting it a product license and co-marketingrights to GastroMARK in the U.S., Canada and Mexico. Covidien currently has rights to GastroMARK in the U.S. only. Under the terms of theagreement, we8Table of Contentsreceive royalties based on GastroMARK sales by Covidien as well as a percentage of sales for supplying the active ingredient. The agreement isperpetual but terminable upon certain specified events.Manufacturing Our Cambridge, Massachusetts manufacturing facility is registered with the FDA and is subject to current Good Manufacturing Practices, orcGMP, as prescribed by the FDA. In this facility, we currently manufacture Feraheme for commercial sale and for use in human clinical trials as well asGastroMARK for commercial sale. To support the commercialization of Feraheme, we have developed a fully integrated manufacturing support system,including quality assurance, quality control, regulatory affairs and inventory control policies and procedures. These support systems are intended toenable us to maintain high standards of quality for our products. In 2009, we began commercial manufacture of Feraheme and currently have only one manufacturing facility at which we produce Feraheme. Ourability to manufacture Feraheme in sufficient quantities and at an acceptable cost to meet our commercial demand and clinical development needs isdependent on the uninterrupted and efficient operation of our manufacturing facility. If there are any difficulties, disruptions or delays in ourmanufacturing process, including quality control problems, we may experience manufacturing failures which could result in product defects or shipmentdelays, recall or withdrawal of Feraheme previously shipped for commercial or clinical purposes, inventory write-offs or the inability to meetcommercial demand for Feraheme in a timely and cost-efficient manner. In addition, if we are unable to produce sufficient quantities of Feraheme tomeet commercial demand or we experience any manufacturing difficulties at our Cambridge, Massachusetts manufacturing facility, we will be requiredto enter into arrangements with third-party manufacturers. We are currently working to establish and qualify second source manufacturing facilities forFeraheme, however we may not be able to enter into agreements on terms acceptable to us with manufacturers whose facilities and procedures arecGMP compliant. Even if we were to reach agreement, the transition of the manufacturing process to a third-party could take a significant amount oftime and may not be successful. Any prolonged interruption in our manufacturing operations could result in cancellations of orders or loss of product inthe manufacturing process. In addition, use of second source manufacturing facilities may increase the risk of certain problems, including cost overruns,process reproducibility, stability issues, an inability to deliver required quantities of product that conform to specifications in a timely manner or theability to manufacture Feraheme in accordance with cGMP. The FDA conducts periodic inspections of our manufacturing facility, procedures, operations and testing of our products to determine whether weare in compliance with cGMP and other FDA regulations. Based on these inspections, the FDA may issue notices that require us to modify ourmanufacturing operations. cGMP regulations require quality control and quality assurance as well as the corresponding maintenance of records anddocumentation. Failure to operate in compliance with cGMP regulations and other applicable manufacturing requirements of various regulatory agenciescould result in the FDA's issuance of Warning Letters, fines, the withdrawal or recall of Feraheme from the marketplace, total or partial suspension ofFeraheme production, the loss of our Feraheme inventory, suspension of the FDA's review of any future supplemental New Drug Applications, orNDAs, enforcement actions, injunctions or criminal prosecution and could impair our ability to obtain product approvals, generate product sales andcontinue our development efforts. Furthermore, we need to continue to recruit, train and retain additional qualified manufacturing and quality control and assurance personnel as wemanufacture Feraheme on a commercial scale. If we fail to attract and retain key members of our manufacturing, quality control or quality assurancedepartments, we may be unable to manufacture sufficient quantities of Feraheme in a timely manner, which could delay our product sales anddevelopment efforts. If we are unable to consistently manufacture our products on a timely basis because of these or other factors, we will not be able to meet demandfor Feraheme.9Table of ContentsRaw Materials We currently purchase certain raw materials used to manufacture Feraheme from third-party suppliers and at present do not have any long-termsupply contracts with these third parties. Although certain of our raw materials are readily available, others may be obtained only from qualifiedsuppliers. Certain raw materials used in Feraheme are procured from a single source without a qualified alternative supplier. We are in the process ofidentifying and qualifying additional third-party suppliers for these raw materials. If any of our third-party suppliers should cease to produce the rawmaterials used in Feraheme or otherwise fail to supply these raw materials to us or fail to supply these raw materials to us in sufficient quantities for anyreason, including any unexpected demand for or shortage of the raw materials, labor disputes or shortages, manufacturing difficulties, regulatoryrequirements or action, adverse financial developments at or affecting the supplier or import or export problems, we would be unable to manufactureFeraheme in sufficient quantities until we are able to qualify an alternative source. The qualification of an alternative source may require repeated testing of the new materials and generate greater expenses to us if materials that wetest do not perform in an acceptable manner. In addition, we sometimes obtain raw materials from one vendor only, even where multiple sources areavailable, in order to maintain quality control and enhance working relationships with suppliers, which could make us susceptible to price inflation bythe sole supplier, thereby increasing our production costs. As a result of the high quality standards imposed on our raw materials, we may not be able toobtain raw materials of the quality required to manufacture Feraheme from an alternative source on commercially reasonable terms, or in a timelymanner, if at all. Any delay in or failure to obtain sufficient quantities of raw materials would prevent us from manufacturing Feraheme, both for commercial saleand for use in clinical trials. In addition, even if we are able to obtain raw materials from an alternative source, if these raw materials are not available ina timely manner or on commercially reasonable terms, we would be unable to manufacture Feraheme, both for commercial sale and for use in clinicaltrials, on a timely and cost-effective basis. Any such difficulty in obtaining raw materials would severely hinder our ability to manufacture Ferahemeand would have a material adverse impact on our ability to generate additional revenues and our ability to achieve profitability.Patents and Trade Secrets We consider the protection of our technology to be material to our business. Because of the substantial length of time and expense associated withbringing new products through development and regulatory approval to the marketplace, we place considerable importance on obtaining patent and tradesecret protection for current and future technologies and products. Our success will, in large part, depend on our ability to maintain the proprietarynature of our technology and other trade secrets. To do so, we must prosecute and maintain existing patents, obtain new patents and ensure trade secretprotection. We must also operate without infringing the proprietary rights of third parties or allowing third parties to infringe our rights. Our policy is to aggressively protect our competitive technology position by a variety of means, including applying for patents in the U.S. and inappropriate foreign countries. We currently hold a number of U.S. and foreign patents, which expire at various times through 2020. Our Ferahemepatents currently expire in 2020, which expiration may be subject to an extension under FDA regulations. Because certain patents that cover ourproducts will begin to expire in the coming years, the protection provided by these patents will also begin to expire. Our inability to protect our productsthrough our patents in any territory and other intellectual property rights prior to their expiration could have a material adverse effect on our business,financial condition and prospects.10Table of Contents We also have patent applications pending in the U.S. and have filed counterpart patent applications in certain foreign countries. Although furtherpatents may be issued on pending applications, we cannot be sure that any such patents will be issued on a timely basis, if at all. In addition, any issuedpatents may not provide us with competitive advantages or may be challenged by others, and the existing or future patents of third parties may limit ourability to commercialize our products. Any limitation on the protection of our technology could hinder our ability to develop and market our productsand product candidates.Competition The pharmaceutical and biopharmaceutical industries are subject to intense competition and rapid technological change. We have competitors bothin the U.S. and internationally, and many have greater financial and other resources and more experienced trade, sales and manufacturing organizationsthan we do. In addition, many of our competitors have name recognition, established positions in the market and long-standing relationships withcustomers and distributors. Feraheme's two primary competitors are Venofer®, which is marketed in the U.S. by Fresenius Medical Care NorthAmerica, or Fresenius, and American Regent Laboratories, Inc., or American Regent, a subsidiary of Luitpold Pharmaceuticals, Inc., or Luitpold, andFerrlecit®, which is marketed by Sanofi-Aventis U.S. LLC. Products developed by our competitors may be or may be perceived to be safer, moreeffective, and/or easier to administer or have more favorable pricing, insurance coverage, coding and reimbursement than Feraheme. In addition, furthertechnological and product developments may make other iron replacement therapy products more competitive than Feraheme, which would adverselyimpact sales of Feraheme as an iron replacement therapeutic agent if such products are approved by the FDA. We may not be able to competesuccessfully with these companies. We believe that our ability to successfully compete depends on a number of factors, including the timing and scope of regulatory approval ofadditional indications and geographies for Feraheme and of products by our competitors, our ability to obtain and maintain favorable pricing, insurancecoverage, coding and reimbursement for Feraheme, our ability to implement effective marketing campaigns, the effectiveness of our sales force, ourability to maintain favorable patent protection for Feraheme, market acceptance of Feraheme and our ability to manufacture sufficient quantities ofFeraheme at commercially acceptable costs. The iron replacement therapy market is highly sensitive to several factors including, but not limited to, the perceived safety profile of the availableproducts, the ability to obtain appropriate insurance coverage, coding and reimbursement, price competitiveness, and product characteristics such asconvenience of administration and dosing regimens. To date, we have not conducted any head-to-head clinical studies comparing Feraheme to other IViron replacement products. There are currently two options for treating IDA in CKD patients: oral iron supplements and IV iron. The National Kidney Foundation's KidneyDisease Outcomes Quality Initiative guidelines recommend IV iron administration for hemodialysis patients with stage 5 CKD, and either oral or IViron for peritoneal dialysis patients and non-dialysis patients with stages 1 through 5 CKD. However, oral iron supplements are poorly absorbed bymany patients, which may adversely impact their effectiveness, and are associated with certain side effects that may adversely affect patient compliancein using such products. The alternative, IV iron, is currently available in the U.S. as ferumoxytol, iron sucrose, sodium ferric gluconate, or iron dextran.The IV iron products comprised of iron sucrose or sodium ferric gluconate are typically administered as a slow push or a fifteen to sixty minuteinfusion in doses of 100 to 200 milligrams, thus requiring five to ten physician visits and repeated IV access for patients to receive a standard one gramtherapeutic course. The iron dextran products are typically administered as a slow push in 100 milligram doses and also require five to ten physicianvisits to receive a standard one gram therapeutic course. Feraheme is administered as a 510 milligram injection followed by a second 510 milligraminjection three to five days later, each of which can be administered11Table of Contentsin as fast as 17 seconds at a regular office visit or during dialysis treatment without the use of infusion equipment or prolonged medical intervention. Feraheme currently competes with four IV iron products in the U.S. for the treatment of IDA in CKD patients. Its two primary competitors areVenofer®, an iron sucrose complex, and Ferrlecit®, a sodium ferric gluconate. Venofer® is currently approved for use in hemodialysis, peritonealdialysis and non-dialysis dependent CKD patients. Ferrlecit® is approved for use only in hemodialysis patients. Dexferrum® is an iron dextran productmarketed by American Regent, and INFeD®, also an iron dextran product, is marketed by Watson Pharmaceuticals, Inc., or Watson. Both iron dextranproducts are used in patients with documented iron deficiency in whom oral iron administration is unsatisfactory or impossible. Based on sales data provided by IMS Health Incorporated, or IMS Health, we estimate that the size of the 2009 U.S. IV iron replacement therapymarket was approximately 1.6 million grams, which represented an increase of approximately 8% over 2008. Of the estimated 1.6 million grams sold inthe U.S. IV iron therapy replacement market in 2009, sales of Venofer® and Ferrlecit® represented approximately 67% and 21%, respectively.Dexferrum® and INFeD® together accounted for approximately 11% of sales of grams of iron in the U.S. market in 2009. Feraheme accounted forapproximately 1% of sales of grams of iron in the U.S. market in 2009. We compete primarily in two segments of the iron replacement therapy market: the dialysis market and the non-dialysis market. The dialysis market is the largest and most established market for IV iron replacement therapies, with two companies serving a significant majorityof all dialysis patients in the U.S. Fresenius, and DaVita, Inc., or DaVita, together treat more than two-thirds of the U.S. dialysis population. InSeptember 2008, Fresenius finalized an exclusive sublicense agreement with Luitpold, the U.S. licensing partner of Vifor Pharma, a subsidiary ofGalenica Ltd., or Galenica, to manufacture, sell and distribute Venofer® to independent outpatient dialysis clinics in the U.S. Luitpold retains the right tosell Venofer® in the U.S. to any other customer. In addition, Galenica, Vifor Pharma, and Fresenius entered into a strategic joint-venture, which becameeffective on January 1, 2009, to market and distribute Venofer® and Ferinject® in the dialysis market in Europe, the Middle East, Africa and LatinAmerica. Fresenius has significant experience selling and distributing dialysis equipment and supplies to outpatient dialysis clinics and, as a result ofthese agreements, it may be more difficult for us to penetrate the dialysis market, in particular at their clinics. We believe there is a significant opportunity for Feraheme in the treatment of IDA in CKD patients not yet on dialysis. The non-dialysis IV ironmarket is comprised primarily of three segments: hospitals, hematology clinics and nephrology clinics. The only primary competitor currently approvedfor use in non-dialysis dependent CKD patients is Venofer®. Our ability to effectively compete with Venofer® in the non-dialysis CKD marketdepends in part upon our ability to gain formulary access in hospitals and effectively promote Feraheme to physicians who treat non-dialysis CKDpatients. In December 2009, Pharmacosmos A/S, or Pharmacosmos, received a positive recommendation in 22 European countries and a final marketingauthorization in Denmark, Iceland and the Netherlands to market Monofer® (iron isomaltoside 1000), its injectable iron preparation for the treatment ofIDA. During 2008, Pharmacosmos completed two Phase III non-comparative open-label studies of IV iron oligosaccharide in CKD patients as well asin congestive heart failure patients. Pharmacosmos is currently recruiting patients for a Phase III comparative open-label study of IV ironoligosaccharide in patients with inflammatory bowel disease and IDA. It is too early to determine whether Monofer® will gain any meaningful share ofthe IV iron market in any country in which it has been approved. In addition to the foregoing currently marketed products, there are several iron replacement therapy products in various stages of clinical andcommercial development in the U.S. and abroad,12Table of Contentsincluding Injectafer®, which is known as Ferinject® in Europe, and soluble ferric pyrophosphate, a form of iron given as part of the hemodialysisprocedure. Galenica, through its subsidiary Vifor (International) Inc., or Vifor, exclusively licenses Injectafer® to Luitpold and American Regent formarketing and sale in the U.S. and Canada. Injectafer® is in development for a variety of anemia-related indications, including the treatment of IDA inCKD patients, whether or not on dialysis. In March 2008, Luitpold received a non-approvable letter from the FDA for Injectafer® for the treatment ofIDA in postpartum women and women with heavy uterine bleeding in the U.S. Luitpold initiated five clinical trials during 2008 and 2009 in an effort toprovide additional data to address the concerns of the FDA. In June 2007, the UK Medicines and Healthcare Products Regulatory Agency approved theregistration of Ferinject®, and it was simultaneously registered in a total of 18 EU countries. Ferinject® is currently marketed in at least 12 Europeancountries. In November 2009, Vifor completed a Phase III study of patients with chronic heart failure and iron deficiency. In addition, Vifor issponsoring ongoing Phase III trials for Ferinject® for the treatment of anemia in patients with inflammatory bowel disease and has stated that it isplanning to initiate a Phase IIIb study to evaluate the long-term efficacy of Ferinject® in non-dialysis dependent CKD patients with IDA. Rockwell Medical, or Rockwell, is developing an iron supplemented dialysate product, a form of iron given as part of the hemodialysis procedure,to be used as a treatment for IDA in dialysis patients. Rockwell has completed a Phase IIb clinical trial and has stated that it intends to initiate Phase IIItrials in the second half of 2010. We do not know when this product might be submitted to the FDA for approval or marketed. If shown to be safe andeffective for the treatment of IDA, this product could compete with Feraheme in the dialysis market segment. In addition to competition from other marketed products and products known by us to be currently under development, the market opportunity forFeraheme could be negatively affected if generic IV iron replacement therapy products were to be approved and achieve commercial success. Forexample, in July 2009, Watson announced that it entered into a license agreement with GeneraMedix, Inc., or GeneraMedix, for the exclusive U.S.marketing rights to a generic version of Ferrlecit®, which is indicated for the treatment of IDA in hemodialysis patients receiving supplemental ESAtherapy. GeneraMedix has filed an Abbreviated NDA with the FDA, which is under expedited review. Companies that manufacture generic productstypically invest far less resources in research and development than the manufacturer of a branded product and can therefore price their productssignificantly lower than those already on the market. It remains unclear if and when a generic product will enter this market. If any of these productcandidates are approved for marketing and sale by the FDA, our efforts to market and sell Feraheme and our ability to generate additional revenues andachieve profitability could be adversely affected.Sales, Marketing and Distribution In July 2009 we began commercial sale of Feraheme, which is being marketed and sold through our own commercial organization ofapproximately 120 professionals, including an 80-person specialized sales force and account management and reimbursement teams. We sell Feraheme primarily through authorized wholesalers and specialty distributors who, in turn, sell Feraheme to nephrologists, hematologists,hospitals, dialysis centers, CKD clinics and infusion centers who treat patients with CKD. In addition, we outsource a number of our product supplychain services to third-party vendors, including services related to warehousing and inventory management, distribution, chargeback processing,accounts receivable management and customer service call center management. Our sales and marketing teams use a variety of common pharmaceutical marketing strategies to promote Feraheme including sales calls toindividual physicians or other healthcare professionals,13Table of Contentssampling programs, medical education symposia, journal advertising, personal and non-personal promotional materials, local and national educationalprograms, scientific meetings and conferences and informational websites. In addition, we provide customer service and other related programs forFeraheme including physician reimbursement support services, a patient assistance program for uninsured or under-insured patients and a customerservice call center. Our sales and marketing strategy focuses on two distinct CKD markets in the U.S.: dialysis dependent and non-dialysis dependent CKD patients.The dialysis market segment is an established market with approximately 400,000 patients currently being treated with a total of approximately 1 milliongrams of IV iron per year. Two thirds of the IV iron given to dialysis patients in the U.S. takes place at the two largest dialysis organizations with theremaining one third at all other dialysis organizations. Our initial focus in the dialysis market has been to encourage potential Feraheme purchasesthrough education, contractual incentives and pilot programs. We believe that the non-dialysis market segment has an annual potential of approximately2 million grams of IV iron use with less than 15% of non-dialysis CKD patients currently being treated with IV iron. We believe there is a significantopportunity in this market to provide IV iron to non-dialysis CKD patients, and our sales team has been working to educate physicians who treat CKDpatients on the benefits of IV iron and the dosing profile of Feraheme in order to change existing treatment paradigms and expand the IV iron use inphysicians' offices, clinics, infusion centers and hospitals where CKD patients are treated. The following table sets forth customers who represented 10% or more of our revenues for the years ended December 31, 2009, 2008 and 2007.No other company accounted for more than 10% of our total revenues in any period presented below. All of the revenues attributable to Cytogen Corporation and a large portion of the revenues attributable to Bayer Healthcare Pharmaceuticals in allperiods presented were previously deferred revenues related to up-front license fees.Government RegulationOverview The development, manufacture and commercialization of pharmaceutical products are subject to extensive regulation by numerous governmentalauthorities in the U.S. and, in some instances, by foreign governments. The Federal Food, Drug, and Cosmetic Act, or the FDC Act, and other federaland state statutes and regulations govern, among other things, the research and development, manufacturing, quality control (testing), labeling, record-keeping, approval, storage, distribution, and advertising and promotion of pharmaceutical products. Failure to comply with any of the applicableregulatory requirements may result in a variety of administrative or judicially imposed sanctions including among other things, the FDA's refusal toapprove pending applications, withdrawals of approval, clinical holds, Warning Letters, product recalls, product seizures, total or partial suspension ofoperations, injunctions, fines, civil penalties or criminal prosecution. The development and approval of a product candidate requires a significant numberof years of work and the expenditure of substantial resources, and is often subject to unanticipated delays and may be subject to new legislation orregulations.14 For the Years Ended December 31, 2009 2008 2007 AmerisourceBergen Drug Corporation 46% — — Metro Medical Supply, Inc. 28% — — Bayer Healthcare Pharmaceuticals <10% 53% 43%Guerbet S.A. <10% 24% 26%Covidien, Ltd. <10% 17% 15%Cytogen Corporation — — 14%Table of Contents In addition to complying with requirements as they currently exist, a sponsor could be negatively impacted by changes in the regulatoryframework. From time to time, legislation is introduced that could significantly alter laws pertaining to the approval, manufacturing and/or marketing ofdrug products. Even without changes to relevant laws, the FDA could release new guidance or revise its implementation of current regulations in amanner that significantly affects us and our products or product candidates, including our ability to receive approval for new indications for existingproducts. It is impossible to predict whether legislative changes will be enacted, or whether FDA regulations or guidances will be amended orsupplemented, or the potential impact of such changes.FDA Approval ProcessClinical Development Before new human pharmaceutical products, including iron replacement therapy products and contrast imaging agents, may be marketed or soldcommercially in the U.S., the FDA requires the following steps: (a) pre-clinical laboratory tests, pre-clinical safety and efficacy studies and formulationstudies; (b) the submission to the FDA of an Investigational New Drug Application, or IND, for human clinical testing, which must become effectivebefore human clinical trials may commence; (c) adequate and well-controlled human clinical trials under current good clinical practices to establish thesafety and efficacy of the drug for its intended use; (d) submission of an NDA to the FDA; (e) approval and validation of manufacturing facilities usedin production of the pharmaceutical product under cGMP; and (f) review and approval of the NDA by the FDA. Pre-clinical studies include the laboratory evaluation of product chemistry and animal studies to assess the potential safety and efficacy of a productand its formulation. The results of such laboratory tests and animal studies are submitted to the FDA as a part of an IND and are reviewed by the FDAprior to and during human clinical trials. If there are no objections from the FDA within 30 days of filing an IND, a sponsor may proceed with initialstudies in human volunteers, also known as clinical trials. Clinical trials are typically conducted in the following three sequential phases, which may overlap in some instances:•Phase I: Clinical trials which involve the initial administration of the study drug to a small group of healthy human volunteers (or, morerarely, to a group of selected patients with the targeted disease or disorder) under the supervision of a principal investigator selected bythe sponsor. These Phase I trials are designed to test for safety, dosage tolerance, absorption, distribution, metabolism, excretion andclinical pharmacology and, if possible, early indications of effectiveness. •Phase II: Clinical trials which involve a small sample of the actual intended patient population and aim to: (a) provide a preliminaryassessment of the efficacy of the investigational drug for a specific clinical indication; (b) ascertain dose tolerance and optimal doserange; and (c) collect additional clinical information relating to safety and potential adverse effects. •Phase III: If an investigational drug is found through Phase I and Phase II studies to have some efficacy and an acceptable clinicalsafety profile in the targeted patient population, Phase III studies can be initiated. Phase III studies are well-controlled comparativestudies designed to gather additional information within an expanded patient population in geographically dispersed clinical trial sites inorder to further establish safety and efficacy in conditions that the drug will be used if approved for marketing.15Table of Contents The FDA may suspend clinical trials at any point in this process if it concludes that patients are being exposed to an unacceptable health risk. Inaddition, clinical trial results are frequently susceptible to varying interpretations by scientists, medical personnel, regulatory personnel, statisticians andothers, which may delay, limit or prevent further clinical development or regulatory approvals of a product candidate.Submission and FDA Review of an NDA Following the successful completion of Phase I, II, and III clinical trials, the results of the trials, together with the results of pre-clinical tests andstudies, are submitted to the FDA as part of an NDA. The NDA must also include information related to the preparation and manufacturing of the newdrug, analytical methods, and proposed product packaging and labeling. When the NDA is submitted, the FDA has 60 days from receipt to determinewhether the application is sufficiently complete to merit a substantive review and should therefore be "filed." If the FDA determines that the applicationis incomplete, it must notify the sponsor through a "refusal-to-file" letter, and the sponsor then has the option to resubmit the NDA after addressing theconcerns raised by the FDA. If the FDA accepts the NDA for filing, the NDA undergoes a series of reviews intended to confirm and validate thesponsor's conclusion that the drug is safe and effective for its proposed use. Under the Food and Drug Administration Modernization Act, an NDA is designated as either Standard Review or Priority Review. A PriorityReview designation may be given if a new drug offers major advancements in treatment or provides a treatment where no adequate therapy exists. TheFDA has, pursuant to the Prescription Drug User Fee Act, set a goal that it review and act upon 90% of NDAs with a Standard Review designationwithin 10 months of their receipt and 90% of NDAs with a Priority Review designation within 6 months of their receipt. However, whether an NDA isdesignated for a Standard or Priority review, there is no guarantee that any single submission will be acted on within these time frames, and the FDA'sgoals are subject to change from time to time. In addition, FDA review of a drug development program may proceed under the "Fast Track" programs,which are intended for a combination of a product and a claim that addresses an unmet medical need. Fast Track is designed to facilitate the developmentand expedite the review of new drugs that are intended to treat serious or life threatening conditions and demonstrate the potential to address unmetmedical needs. A Fast Track designation provides the sponsor the benefits of scheduling meetings when needed to receive FDA input into developmentplans, the option of submitting an NDA in sections rather than all components simultaneously, or a rolling review, and the option of requestingevaluation of studies using surrogate endpoints. Fast Track status does not, however, necessarily lead to a Priority Review or Accelerated Approvaldesignation. If the FDA's evaluations of the NDA and the sponsor's manufacturing facilities are favorable, the FDA will issue an approval letter, and thesponsor may begin marketing the drug in the U.S. for the approved indications, subject to certain universal post-approval requirements described furtherbelow. The FDA may also impose drug-specific conditions on its approval, such as requirements for additional post-marketing testing or surveillance.If the FDA determines that it cannot approve the NDA in its current form, it will issue a complete response letter to indicate that the review cycle for anapplication is complete and that the application will not be approved in its current form. The complete response letter usually describes the specificdeficiencies that the FDA identified in the application and may require additional clinical or other data or impose other conditions that must be met inorder to obtain final approval of the NDA. Addressing the deficiencies noted by the FDA could be impractical or costly and may result in significantdelays prior to final approval.16Table of ContentsAdverse Event Reporting The FDA requires us to submit reports of certain information on side effects and adverse events associated with our products that occur eitherduring clinical trials or after marketing approval. These requirements include specific and timely notification of certain serious, unexpected and/orfrequent adverse events, as well as regular periodic reports summarizing adverse drug experiences. Failure to comply with these FDA safety reportingrequirements may result in FDA regulatory action that may include civil action or criminal penalties. In addition, as a result of these reports, the FDAcould place additional limitations on an approved product's use, such as through labeling changes, and, potentially, could require withdrawal orsuspension of the product from the market.FDA Post-Approval Requirements Even if initial approval of an NDA is granted, such approval is subject to a wide-range of regulatory requirements, any or all of which mayadversely impact a sponsor's ability to effectively market and sell the approved product. Furthermore, the FDA may require the sponsor to conductPhase IV clinical trials, also known as post-marketing requirements or post-marketing commitments, to provide additional information on safety andefficacy. The results of such post-market studies may be negative and could lead to limitations on the further marketing of a product. Also, under thePediatric Research Equity Act, the FDA may require pediatric assessment of certain drugs unless waived or deferred due to the fact that necessarystudies are impossible or highly impractical to conduct or where there is strong evidence that suggests the drug would be ineffective or unsafe or that thedrug does not represent a meaningful therapeutic benefit over existing therapies and is not likely to be used in a substantial number of pediatric patients.In addition, the FDA may require a sponsor to implement a Risk Evaluation and Mitigation Strategy, or REMS, a strategy to manage a known orpotential serious risk associated with the product. The FDA may, either prior to approval or subsequent to approval if new safety data arises, require aREMS if it determines that a REMS is necessary to ensure that the benefits of the product outweigh its risks. A REMS may include a medication guide,patient package insert, a plan for communication with healthcare providers, elements to ensure safe use of the product, and an implementation system. AREMS must also include a timetable for submission of assessments of the strategy at specified time intervals. Failure to comply with a REMS,including submission of a required assessment, may result in substantial civil penalties. Where a sponsor wishes to expand the originally approved prescribing information, such as adding a new indication, or otherwise change theproduct formulation or manufacturing and testing requirements, it must submit and obtain approval of a supplemental NDA. Supplemental NDAsgenerally require additional clinical studies, which can be time-consuming and require the expenditure of substantial additional resources.FDA Regulation of Product Marketing and Promotion The FDA also regulates all advertising and promotional activities for products, both prior to and after approval, including but not limited to direct-to-consumer advertising, sales representative communications to healthcare professionals, promotional programming, and promotional activitiesinvolving the internet, publications, radio and TV as well as other media. Approved drug products must be promoted in a manner consistent with theirterms and conditions of approval, including the scope of their approved use. The FDA may take enforcement action against a company for promotingunapproved uses of a product, or off-label promotion, or for other violations of its advertising and labeling laws and regulations. Failure to comply withthese requirements could lead to, among other things, adverse publicity, product seizures, civil or criminal penalties, or regulatory letters, which mayinclude warnings and require corrective advertising or other corrective communications to healthcare professionals.17Table of ContentsFDA Regulation of Manufacturing Facilities Manufacturing procedures and quality control for approved drugs must conform to cGMP, which practices are described in the FDC Act andFDA guidance. cGMP requirements must be followed at all times, and domestic manufacturing establishments are subject to periodic inspections by theFDA in order to assess, among other things, cGMP compliance. In addition, prior to approval of an NDA, the FDA will perform a pre-approvalinspection of the sponsor's manufacturing facility, including its equipment, facilities, laboratories and processes, to determine the facility's compliancewith cGMP and other rules and regulations. Vendors that supply finished products or components to the sponsor that are used to manufacture, packageand label products are subject to similar regulation and periodic inspections. If the FDA identifies deficiencies during an inspection, it may issue noticeson FDA Form 483 followed by Warning Letters listing conditions the FDA investigators believe may violate cGMP or other FDA regulations. FDAguidelines specify that a Warning Letter be issued only for violations of "regulatory significance" for which the failure to adequately and promptlyachieve correction may be expected to result in an enforcement action. Product approval may be delayed or denied due to cGMP non-compliance or other issues at the sponsor's manufacturing facilities or contractorsites or suppliers included in the NDA, and the complete resolution of these inspectional findings may be beyond the sponsor's control. If after asuccessful completion of an FDA inspection of a sponsor's manufacturing facilities, the sponsor makes a material change in manufacturing equipment,location or process, additional regulatory review may be required. Re-inspection of the sponsor's manufacturing facilities or contractor sites or suppliersmay also occur. If the FDA determines that the sponsor's equipment, facilities, laboratories or processes do not comply with applicable FDA regulationsand conditions of product approval, the FDA may seek civil, criminal or administrative sanctions and/or remedies against the sponsor, includingsuspension of its manufacturing operations. To supply products for use in the U.S., foreign manufacturing establishments must also comply with cGMP and are subject to periodic inspectionby the FDA or by regulatory authorities in certain of such countries under reciprocal agreements with the FDA. In complying with these requirements,manufacturers, including a drug sponsor's third-party contract manufacturers, must continue to expend time, money and effort in the area of productionand quality to ensure compliance. Failure to maintain compliance with cGMP regulations and other applicable manufacturing requirements of variousregulatory agencies could result in fines, unanticipated compliance expenditures, recall, total or partial suspension of production, suspension of theFDA's review of future supplemental NDAs, enforcement actions, injunctions or criminal prosecution.Fraud and abuse regulation Our general operations, and the research, development, manufacture, sale and marketing of our products, are subject to extensive federal and stateregulation, including but not limited to FDA regulations, the federal anti-kickback statute and the federal false claims act. Anti-kickback laws make itillegal to solicit, offer, receive or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of aparticular drug, that is reimbursed by a state or federal program. False claims laws prohibit anyone from knowingly presenting, or causing to bepresented for payment to third-party payers, including Medicare and Medicaid, false or fraudulent claims for reimbursed drugs or services, claims foritems or services not provided as claimed, or claims for medically unnecessary items or services. Our activities relating to the sale and marketing of ourproducts may be subject to scrutiny under these laws. If we or our representatives fail to comply with any of these laws or regulations, a range of fines,penalties and/or other sanctions could be imposed on us, including, but not limited to, the termination of our clinical trials, restrictions on how wemarket18Table of Contentsand sell Feraheme, restrictions on our manufacturing processes, significant fines, exclusions from government healthcare programs, including Medicareand Medicaid, litigation, or other sanctions.Other U.S. Regulatory Requirements We are also subject to regulation under local, state and federal law regarding occupational safety, laboratory practices, handling of chemicals,environmental protection and hazardous substances control. We possess a Byproduct Materials License from the Commonwealth of Massachusetts forreceipt, possession, manufacturing and distribution of radioactive materials and Registration Certificates from the federal Drug Enforcement Agency andthe Commonwealth of Massachusetts Department of Public Health for handling controlled substances. We are also registered with the federalEnvironmental Protection Agency, or EPA, as a generator of hazardous waste. All hazardous waste disposals must be made in accordance with EPAand Commonwealth of Massachusetts requirements. We are subject to the regulations of the Occupational Safety and Health Act and have a safetyprogram in effect to assure compliance with all of these regulations. We believe our procedures for handling and disposing of hazardous materials usedin our research and development activities comply with all applicable federal, state and local requirements. Nevertheless, the risk of accidentalcontamination or injury from these materials cannot be completely eliminated and, in the event of an accident or injury, we could be held liable for anydamages that result. Certain states also require that we obtain licenses or permits as an out-of-state distributor or manufacturer in order to market, sell and/or ship ourpharmaceutical products into their state. We have obtained licenses and permits in some states and, depending on our future activities, may also need toobtain additional licenses or permits in other areas where we decide to manufacture, market or sell our products. New laws, regulations or judicialdecisions, or new interpretations of existing laws and regulations, may require us to modify our development programs, revise the way we manufacture,market and sell our products, require additional clinical trials or post-approval safety studies, or limit coverage or reimbursement for our products. In recent years, several states, including California, Maine, Massachusetts, Minnesota, Nevada, New Mexico, Vermont and West Virginia, as wellas the District of Columbia, have enacted legislation requiring pharmaceutical companies operating within the state to establish marketing andpromotional compliance programs and/or file periodic reports with the state with respect to sales, marketing, pricing, and other activities. Similarlegislation is being considered in a number of other states, as well as by the federal government. Many of these requirements are new and uncertain, andavailable guidance is limited. Failure to comply with any of these laws could result in a range of fines, penalties and/or other sanctions.Foreign Regulatory Process To the extent we choose to develop, manufacture, market or sell Feraheme in foreign countries, we will also be subject to foreign regulatoryrequirements, which vary widely from country to country. Approval of a drug by applicable regulatory agencies of foreign countries must be securedprior to the marketing of such drug in those countries. The regulatory approval process in countries outside of the U.S. may be more or less rigorous ascompared with the U.S., and the time required for approval may differ from that required in the U.S. In addition, obtaining marketing approval inforeign countries may involve additional requirements from what the FDA requires. To obtain regulatory approval of a drug in the EU, marketing authorizations may be submitted under a centralized, mutual recognition ordecentralized procedure or national procedure (single country). Under the centralized procedure, the sponsor can submit a single application to theEMEA which, if approved, permits the marketing of a product in all EU Member States. Under the mutual19Table of Contentsrecognition procedure, the sponsor applies for national marketing authorization in one state, and upon approval can then seek simultaneous approval inall other EU Member States. Under the decentralized procedure, the sponsor can file simultaneously to several EU Member States, identifying a singlereference member state to act as the primary reviewer of the application. Upon approval, the product will be licensed only in the reference member stateand the other countries to which it applied. Once an applicant receives marketing authorization in an EU Member State, through any application route,the applicant is then required to engage in pricing discussions and negotiations with a separate pricing authority in that country. Commercial sales areonly able to commence in a country once pricing approval has been received.Reimbursement In both the U.S. and foreign markets, our ability to successfully commercialize Feraheme depends in significant part on the availability of adequateinsurance coverage and reimbursement from government programs, including Medicare and Medicaid, private health insurers, and other third-partypayors. Third-party payors are increasingly challenging prices charged for pharmaceutical products and evaluating their cost effectiveness. In addition,the U.S. and many foreign governments have been and continue to attempt to curb health care costs through legislation, including legislation aimed atreducing the pricing and reimbursement of pharmaceutical products. Currently, in the hospital outpatient, dialysis center and physician clinic settings, Medicare Part B generally reimburses for physician-administereddrugs at 106% of its average sales price, or ASP. When a new product is launched, historical sales data is not available and, until such time as CMSbelieves it has sufficient data to accurately determine the product's ASP, providers are instead generally reimbursed at 106% of the product's wholesaleacquisition cost. Once available, ASP is defined by statute based on certain historical sales and sales incentive data including rebates and chargebacksfor a defined period of time. Manufacturers submit the required information to CMS on a quarterly basis. CMS then confirms and publishes the ASPfor products in advance of the quarter in which the ASP will go into effect. Under this methodology, payment rates change on a quarterly basis, andsignificant downward fluctuations in ASP, and therefore reimbursement rates, could negatively impact sales of a product. Because ASP is defined by statute, and changes to Medicare payment methodologies require legislative change, it is unclear if and when ASPreimbursement methodology will change. We cannot predict the impact any changes in reimbursement policies may have on our ability to competeeffectively. In July 2008, Congress enacted the Medicare Improvements for Patients and Providers Act of 2008, or MIPPA, which created a Medicare-expanded bundled payment system for the treatment of end stage renal disease, or ESRD, to be implemented by January 1, 2011. MIPPA requiresCMS to move from a system in which it pays separately for physician-administered drugs for dialysis patients to a system in which all costs ofproviding care to dialysis patients are bundled together into a single capitated payment. The ESRD expanded bundle is to be phased in beginning onJanuary 1, 2011, and the phase-in must be completed by January 1, 2014. In September 2009, in compliance with the statutory requirements of MIPPA,CMS proposed a new prospective payment system for dialysis services provided to Medicare beneficiaries who have ESRD. CMS intends to issue afinal rule on the prospective payment system later in 2010 in order to meet the legislative requirements of implementation by January 1, 2011. Given theuncertainties surrounding bundling, we cannot predict the impact such a system will have on sales of Feraheme in the dialysis setting. Bundlinginitiatives implemented in other healthcare settings, however, have frequently resulted in lower utilization of products and services that were added as acomponent of a bundled payment. Therefore, it is possible that the implementation of a bundled reimbursement system in the ESRD market could have a20Table of Contentsmaterial negative impact on sales of Feraheme in the dialysis market, the price we charge for Feraheme, and our overall revenues. While the MIPPA ESRD provisions apply only to Medicare, Medicare payment policy can also influence pricing and reimbursement in the non-Medicare markets, as private third-party payors and state Medicaid plans frequently adopt Medicare principles in setting reimbursement methodologies,particularly in the ESRD setting. In addition, when a new product is approved, a failure to demonstrate clear economic value associated with the use ofthe new product as compared to existing products may result in inadequate or no reimbursement. For example, to reduce expenditures associated withpharmaceutical products, many third-party payors use cost containment methods, including: (a) formularies, which limit coverage for drugs not includedon the predetermined list; (b) step therapy, which is a program used to encourage the use of lower cost alternative treatments; (c) variable co-payments,which may make a certain drug more expensive for patients as compared with a competing drug; and (d) utilization management controls, such asrequirements for prior authorization before the payor will cover the drug or other coverage policies that limit access to certain drugs for certain usesbased on the payor specific coverage policy. In addition, for providers to obtain reimbursement for Feraheme from Medicare, Medicaid and most third-party payors, specific codes must besubmitted by the provider with each claim in order to help the payor identify the product used. These codes are issued to manufacturers at the discretionof CMS. Until a new product obtains a unique drug code, it can only be billed by using a miscellaneous drug code. Inclusion of this miscellaneous drugcode will subject each claim to manual review and could delay or prevent reimbursement. In November 2009, CMS assigned Feraheme two unique Q-codes, one for the treatment of IDA in ESRD patients undergoing dialysis and one for the treatment of IDA in non-ESRD patients. These Q-codes,which are temporary product-specific codes that enable automated processing of Feraheme-related claims, became effective on January 1, 2010. Thenew codes must be adopted by payors in order to facilitate claims processing. If adequate reimbursement levels are not maintained by government and other third-party payors for Feraheme, our ability to sell Feraheme maybe limited and/or our ability to establish acceptable pricing levels for Feraheme may be impaired, thereby reducing anticipated revenues. In addition,some foreign countries require that the pricing for new drugs be approved before the drug can be sold and/or marketed in that country, and there is noguarantee that our proposed prices will be approved.Backlog Generally, we do not have a significant backlog. Product orders from our customers are typically fulfilled within a relatively short time of receipt ofa customer order. We had a $0.1 million and $0.2 million product sales backlog as of December 31, 2009 and 2008, respectively.Employees As of February 16, 2010, we had 283 employees. We also utilize consultants and independent contractors on a regular basis to assist in thedevelopment and commercialization of our products. Our success depends in part on our ability to recruit and retain talented and trained scientific,clinical, regulatory, manufacturing, and sales and marketing personnel, as well as senior management. Although we believe we have been relativelysuccessful to date in obtaining and retaining such personnel, we may not be successful in the future. None of our employees is represented by a labor union, and we consider our relationship with our employees to be good.21Table of ContentsForeign Operations We have no foreign operations. Revenues for the years ended December 31, 2009, 2008 and 2007 from customers outside of the U.S., principallyin Europe, amounted to 2%, 29% and 28%, respectively, of our total revenues.Research and Development We have dedicated a significant portion of our resources to our efforts to develop our product candidates, particularly Feraheme. We incurredresearch and development expenses of $36.3 million, $31.7 million and $24.2 million during the years ended December 31, 2009, 2008 and 2007,respectively. We anticipate that a significant portion of our operating expenses will continue to be related to research and development in 2010 as weseek to obtain marketing approval for Feraheme in countries outside of the U.S. and expand the approved indications for Feraheme in the U.S.Code of Ethics Our Board of Directors, or the Board, has adopted a code of ethics that applies to our officers, directors and employees. In August 2009, the Boardapproved certain amendments to our code of ethics to clarify and better organize it and to make it more appropriate for a company of our size and stageof development. We have posted the text of our code of ethics on our website at http://www.amagpharma.com in the "Investors" section. In addition,subject to NASDAQ regulations, we intend to promptly disclose (1) the nature of any amendment to our code of ethics that applies to our principalexecutive officer, principal financial officer, principal accounting officer, or persons performing similar functions and (2) the nature of any waiver,including an implicit waiver, from a provision of our code of ethics that is granted to one of these specified officers, the name of such person who isgranted the waiver, and the date of the waiver on our website (or in any other medium required by law or the NASDAQ) in the future.Available Information Our internet website address is http://www.amagpharma.com. Through our website, we make available, free of charge, our annual reports onForm 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, any amendments to those reports, proxy and registration statements, and allof our insider Section 16 reports, as soon as reasonably practicable after such material is electronically filed with, or furnished to, the U.S. Securitiesand Exchange Commission, or the SEC. These SEC reports can be accessed through the "Investors" section of our website. The information found onour website is not part of this or any other report we file with, or furnish to, the SEC. Paper copies of our SEC reports are available free of charge uponrequest in writing to Investor Relations, AMAG Pharmaceuticals, Inc., 100 Hayden Avenue, Lexington, MA 02421. The content on any websitereferred to in this Form 10-K is not incorporated by reference into this Form 10-K unless expressly noted. For additional information regarding our segments, refer to Note L of the Notes to Financial Statements included in Part II, Item 8 "FinancialStatements and Supplementary Data" of this Annual Report on Form 10-K.22Table of ContentsITEM 1A. RISK FACTORS: The following is a summary description of some of the material risks and uncertainties that may affect our business, including our future financialand operational results. In addition to the other information in this Annual Report on Form 10-K, the following statements should be carefullyconsidered in evaluating us.We are solely dependent on the success of Feraheme. Our ability to generate future revenues is solely dependent on our successful commercialization and development of Feraheme. We currently sellonly one other product, GastroMARK, in the U.S. and in certain foreign jurisdictions through our marketing partners. However, sales of GastroMARKhave been at their current levels for the last several years, and we do not expect sales of GastroMARK to materially increase. Accordingly, if we areunable to generate sufficient revenues from sales of Feraheme, we may never be profitable, our financial condition will be materially adversely affected,and our business prospects will be limited. We intend to dedicate significant resources to our Feraheme development efforts; however, we may not be successful in expanding the potentialindications or developing new applications for Feraheme. Although we are pursuing or have commenced additional clinical trials for Feraheme inindications other than chronic kidney disease, or CKD, and as an imaging agent, we are not currently conducting or sponsoring research to expand ourproduct development pipeline beyond Feraheme and therefore our revenues and operations will not be as diversified as some of our competitors whichhave multiple products or product candidates. Any failure by us to acquire, develop and commercialize additional products and product candidates orgain approval for additional indications or uses for Feraheme could limit long-term shareholder value and would adversely affect the future prospects ofour business.Competition in the pharmaceutical and biopharmaceutical industries is intense. If our competitors are able to develop and market products thatare or are perceived to be more effective, safer, more convenient or have more favorable pricing, insurance coverage, coding and reimbursementthan Feraheme, the commercial opportunity for Feraheme will be adversely impacted. The pharmaceutical and biopharmaceutical industries are subject to intense competition and rapid technological change. We have competitors bothin the U.S. and internationally, and many have greater financial and other resources, and more experienced trade, sales, and manufacturingorganizations, than we do. In addition, many of our competitors have name recognition, established positions in the market and long-standingrelationships with customers and distributors. Our Feraheme commercial opportunity will be reduced or eliminated if our competitors develop,commercialize or acquire or license technologies and drug products that are or are perceived to be safer, more effective, and/or easier to administer, orhave more favorable pricing, insurance coverage, coding and reimbursement than Feraheme. There are currently two options for treating iron deficiency anemia, or IDA, in CKD patients: oral iron supplements and intravenous, or IV, iron.Feraheme primarily competes with two other IV iron replacement therapies, including Venofer®, which is marketed in the U.S. by Fresenius MedicalCare North America, or Fresenius, and American Regent Laboratories, Inc., a subsidiary of Luitpold Pharmaceuticals, Inc., or Luitpold, and Ferrlecit®,which is marketed by Sanofi-Aventis U.S. LLC. Feraheme may not receive the same level of market acceptance as these competing iron replacementtherapy products, especially since these products have been on the market longer and are currently widely used by physicians. We may not be able toconvince physicians and other healthcare providers or payors to switch from using the other marketed IV iron therapeutic products to Feraheme. Theiron replacement therapy market is highly sensitive to several factors including, but not limited to, the actual and perceived safety profile of the availableproducts, the ability to obtain appropriate insurance coverage, coding and reimbursement, price competitiveness, and product characteristics such as23Table of Contentsconvenience of administration and dosing regimens. To date, we have not conducted any head-to-head clinical studies comparing Feraheme to other IViron replacement products. In addition to the foregoing currently marketed products, there are several iron replacement therapy products in various stages of clinical andcommercial development in the U.S. and abroad, including Monofer® (iron isomaltoside 1000), an injectable iron preparation which in December 2009received a positive recommendation in 22 European countries and a final marketing authorization in Denmark, Iceland and the Netherlands for thetreatment of IDA, Injectafer®, which is known as Ferinject® in Europe and is approved for marketing in 18 European Union countries, and solubleferric pyrophosphate, a form of iron given as part of the hemodialysis procedure. In addition to competition from other marketed products and products known by us to be currently under development, the market opportunity forFeraheme could be negatively affected if generic IV iron replacement therapy products were to be approved and achieve commercial success. Forexample, in July 2009, Watson Pharmaceuticals, Inc. announced that it entered into a license agreement with GeneraMedix, Inc. for the exclusive U.S.marketing rights to a generic version of Ferrlecit®, which is indicated for the treatment of IDA in hemodialysis patients receiving supplementalerythropoiesis stimulating agent therapy. GeneraMedix, Inc. has filed an Abbreviated New Drug Application, or NDA, with the U.S. Food and DrugAdministration, or FDA, which is under expedited review. Companies that manufacture generic products typically invest far less resources in researchand development than the manufacturer of a branded product and can therefore price their products significantly lower than those already on the market.It remains unclear if and when a generic product will enter this market. If any of these product candidates are approved for marketing and sale by the FDA, our efforts to market and sell Feraheme and our ability togenerate additional revenues and achieve profitability could be adversely affected.Feraheme may not be widely adopted by physicians, patients, healthcare payors, and the major operators of dialysis clinics in the U.S. The commercial success of Feraheme depends upon its level of market adoption by physicians, patients, and healthcare payors or providers,including dialysis clinics. If Feraheme does not achieve an adequate level of market adoption for any reason, our potential profitability and our futurebusiness prospects would be severely adversely impacted. Feraheme represents an alternative to other products and might not be adopted by the medicalcommunity if perceived to be no safer, no more effective, or no more convenient than currently available products. The degree of market acceptance ofFeraheme depends on a number of factors, including but not limited to:•Our ability to demonstrate to the medical community, particularly nephrologists, hematologists, dialysis clinics and others who maypurchase or prescribe Feraheme, the clinical efficacy and safety of Feraheme as an alternative to current treatments for IDA in bothdialysis and non-dialysis CKD patients; •The ability of physicians and other providers to be adequately reimbursed for Feraheme in a timely manner from payors, includinggovernment payors, such as Medicare and Medicaid, and private payors, particularly in light of the expected "bundling" of costs ofproviding care to dialysis patients; •The relative price of Feraheme as compared to alternative iron replacement therapeutic agents; •The actual or perceived convenience and ease of administration of Feraheme as compared to alternative iron replacement therapeuticagents;24Table of Contents•The effectiveness of our sales and marketing organizations and our distribution network; and •The development of unanticipated adverse reactions to Feraheme resulting in safety concerns among prescribers. We market and sell Feraheme for use by both dialysis and non-dialysis CKD patients. The dialysis market is the largest and most establishedmarket for IV iron replacement therapies, with two companies serving a significant majority of all dialysis patients in the U.S. Fresenius andDaVita, Inc., or DaVita, together treat approximately two-thirds of the U.S. dialysis population. If we are unable to successfully market and sellFeraheme to physicians who treat dialysis dependent CKD patients in clinics controlled by either or both of Fresenius and DaVita, our ability to realizeand grow revenues from sales of Feraheme could be limited. In addition, if we are unable to successfully market and sell Feraheme to a significantnumber of the dialysis clinics that treat the remaining one-third of the U.S. dialysis population, our potential profitability and our future businessprospects could be materially adversely impacted. In September 2008, Fresenius finalized an exclusive sublicense agreement with Luitpold, the U.S. licensing partner of Vifor Pharma, a subsidiaryof Galenica Ltd., to manufacture, sell and distribute Venofer®, an IV iron replacement therapeutic, to independent outpatient dialysis clinics in the U.S.Luitpold retains the right to sell Venofer® in the U.S. to any other customer. In addition, Galenica Ltd., Vifor Pharma and Fresenius entered into astrategic joint-venture, which became effective on January 1, 2009, to market and distribute the IV iron products Venofer® and Ferinject® in thedialysis market in Europe, the Middle East, Africa and Latin America. Fresenius has significant experience selling and distributing dialysis equipmentand supplies to outpatient dialysis clinics and, as a result of these agreements, it may be difficult for us to penetrate the dialysis market, particularly at itsclinics. Another key component of our commercialization strategy is to market and sell Feraheme for use by non-dialysis CKD patients. The current non-dialysis market is comprised primarily of three segments: hospitals, hematology clinics and nephrology clinics. Our ability to effectively market and sellFeraheme in the hospital market depends in part upon our ability to achieve acceptance of Feraheme onto hospital formularies. In addition, since manyhospitals are members of group purchasing organizations, which leverage the purchasing power of a group of entities to obtain discounts based on thecollective bargaining power of the group, our ability to attract customers in the hospital market also depends in part on our ability to effectively promoteFeraheme within group purchasing organizations. In addition, IV iron therapeutic products are not currently widely used by certain physicians whotreat non-dialysis CKD patients due to safety concerns and the inconvenience and often impracticability of administering IV iron therapeutic products. Itis often difficult to change physicians' existing treatment paradigms even when supportive clinical data is available. If we are not successful in securingand maintaining formulary coverage for Feraheme or are significantly delayed in doing so or if we are not successful in effectively promotingFeraheme to physicians who treat non-dialysis CKD patients , we will have difficulty achieving market acceptance of Feraheme in the non-dialysismarket and our ability to generate revenues and achieve and maintain profitability, and our long-term business prospects, could be adversely affected.Our ability to generate future revenues from Feraheme depends heavily on the ability of end-users to receive adequate reimbursement for the useof Feraheme in a timely manner. The commercial success of Feraheme substantially depends on the availability and extent of reimbursement for Feraheme from third-party payors,including governmental payors, such as Medicare and Medicaid, and private payors. Feraheme is purchased by hospitals, clinics, dialysis centers,physicians and other users, each of which generally relies on third-party payors to reimburse them or their patients for pharmaceutical productsadministered in the hospital, clinic, dialysis center and25Table of Contentsphysician-office settings. Public and private insurance coverage and reimbursement plans are therefore central to new product acceptance, withcustomers unlikely to use Feraheme if they do not receive adequate reimbursement in a timely manner. If Feraheme is not reimbursed at an adequatelevel, our ability to generate revenues from sales of Feraheme, our potential profitability and our future business prospects would be adversely affected.In the U.S. there have been, and we expect there will continue to be, a number of federal and state proposals to reform the healthcare system inways that could adversely impact the available reimbursement for, and therefore our ability to sell Feraheme profitably. In the U.S., both federal and state agencies continue to promote efforts to reduce healthcare costs. For example, one of the proposals included inrecently proposed federal healthcare legislation would require pharmaceutical manufacturers to be responsible for higher Medicaid rebates owed to stateMedicaid agencies. As a result of reimbursement and legislative proposals, and the trend toward managed health care in the U.S., third-party payors,including government and private payors, are also increasingly attempting to contain health care costs by limiting the coverage and the level ofreimbursement of new drugs. These cost-containment methods may include, but are not limited to, using formularies, which are lists of approved orpreferred drugs, requiring prior authorization or step therapy, which is a program to encourage using lower cost alternative treatments, basing paymentamounts on the least costly alternative treatment, or refusing to provide coverage of approved products for medical indications other than those forwhich the FDA has granted marketing approval. Cost control initiatives could adversely affect the commercial opportunity or decrease the price ofFeraheme and may impede the ability of potential Feraheme users to obtain reimbursement, any of which could have a material adverse effect on ourprofitability and future business prospects. Medicare currently reimburses for physician-administered drugs in the hospital outpatient, dialysis center and physician clinic settings at a rate of106% of the drug's average selling price, or ASP. If the Centers for Medicare & Medicaid Services, or CMS, or one of its local contractors, believe thatFeraheme's ASP is too high, it may attempt to initiate one or more of the cost-containment methods discussed above at either the national or local level.In July 2008, Congress enacted the Medicare Improvements for Patients and Providers Act of 2008, or MIPPA, which created a Medicare-expandedbundled payment system for the treatment of end stage renal disease, or ESRD, to be implemented by January 1, 2011. MIPPA requires CMS to movefrom a system in which it pays separately for physician-administered drugs for dialysis patients to a system in which all costs of providing care todialysis patients are bundled together into a single capitated payment. The ESRD expanded bundle is to be phased in beginning on January 1, 2011, andthe phase-in must be completed by January 1, 2014. In September 2009, in compliance with the statutory requirements of MIPPA, CMS proposed anew prospective payment system for dialysis services provided to Medicare beneficiaries who have ESRD. CMS has stated that it intends to issue afinal rule on the prospective payment system later in 2010 in order to meet the legislative requirements of implementation by January 1, 2011. Thisbundled approach to reimbursement may lower utilization of physician-administered drugs in the ESRD market. In addition, the bundled approach toreimbursement in the dialysis setting may lower the amount of reimbursement available for Feraheme and consequently put downward pressure on theprice we can charge for Feraheme. Therefore, we may be limited in our ability to successfully market and sell Feraheme in the dialysis setting. Whilethe MIPPA ESRD provisions apply only to Medicare, Medicare payment policy can also influence pricing and reimbursement in the non-Medicaremarkets, as private third-party payors and state Medicaid plans frequently adopt Medicare principles in setting reimbursement methodologies,particularly in the ESRD setting. Any change in the Medicare reimbursement rate would, therefore, likely result in changes to payment rates from non-Medicare payors as well, further limiting our ability to successfully market and sell Feraheme.26Table of Contents To the extent we sell our products internationally, market acceptance may also depend, in part, upon the availability of reimbursement withinexisting healthcare payment systems. Generally, in Europe and other countries outside of the U.S., the government sponsored healthcare system is theprimary payor of healthcare costs of patients and therefore enjoys significant market power. Some foreign countries also set prices for pharmaceuticalproducts as part of the regulatory process, and we cannot guarantee that the prices set by such governments will be sufficient to generate substantialrevenues in those countries.Significant safety or drug interaction problems could arise with respect to Feraheme, resulting in recalls, restrictions in Feraheme's label,withdrawal of Feraheme from the market, or cause us to alter or terminate future Feraheme clinical development programs. Discovery of previously unknown problems with an approved product may result in recalls, restrictions on the product's permissible uses, orwithdrawal of the product from the market. The data submitted to the FDA as part of our NDA was obtained in controlled clinical trials of limitedduration. New safety or drug interaction issues may arise as Feraheme is used over longer periods of time by a wider group of patients takingnumerous other medicines and with additional underlying health problems. In addition, as we conduct additional clinical trials for Feraheme, new safetyproblems may be identified which could negatively impact both our ability to successfully complete these studies and the use and/or regulatory status ofFeraheme for the treatment of IDA in patients with CKD. These new safety or drug interaction issues may require us to provide additional warnings onthe Feraheme label, directly alert healthcare providers of new safety information, narrow our approved indications, or alter or terminate future trialsplanned for additional uses of Feraheme, any of which could reduce the market acceptance of Feraheme. In addition, if significant safety or druginteraction issues arise, FDA approval for Feraheme could be withdrawn, and the FDA could require the recall of all existing Feraheme in themarketplace. The FDA also has the authority to require the recall of our products if there is contamination or other problems with manufacturing,transport or storage of the product. A government-mandated recall or a voluntary recall could divert managerial and financial resources, could bedifficult and costly to correct, could result in the suspension of sales of Feraheme, and could have a severe adverse impact on our potential profitabilityand the future prospects of our business. We may also be required to conduct certain post-approval clinical studies to assess known or suspected significant risks associated with Feraheme.The Food and Drug Administration Amendments Act of 2007 expanded the FDA's authority. Under the Food and Drug Administration AmendmentsAct, the FDA may: (i) require manufacturers to conduct post-approval clinical studies to assess known risks or signals of serious risks, or to identifyunexpected serious risks; (ii) mandate labeling changes to a product based on new safety information; or (iii) require sponsors to implement a RiskEvaluation Management Strategy, or REMS, where necessary to assure safe use of the drug. If we are required to conduct post-approval clinical studiesor implement a REMS, or if the FDA changes the label for Feraheme to include additional discussion of potential safety issues, such requirements orrestrictions could have a material adverse impact on our ability to generate revenues from sales of Feraheme, or require us to expend significantadditional funds on clinical studies.We have limited experience independently commercializing a pharmaceutical product, and any failure on our part to effectively execute ourFeraheme commercial plans would have a severe adverse impact on our business. Prior to our commercialization of Feraheme, we have never independently marketed or sold a drug product as we had relied on our corporatepartners to market and sell our other approved products, Feridex I.V. and GastroMARK. We have established an internal sales and marketinginfrastructure to market and sell Feraheme, and if we are unsuccessful in maintaining an effective sales and marketing function or experience a highlevel of turnover, then the commercialization of Feraheme could be27Table of Contentsseverely impaired. Any failure by us to successfully execute our commercialization plans for Feraheme could have a material adverse impact on ourability to generate revenues, our ability to achieve profitability, and the future prospects for our business.We have limited experience independently distributing a pharmaceutical product, and our Feraheme commercialization plans could suffer if wefail to effectively manage and maintain our supply chain and distribution network. We do not have significant experience in managing and maintaining a supply chain and distribution network, and we are placing substantialreliance on third-parties to perform product supply chain services for us. Such services include packaging, warehousing, inventory management, storageand distribution of Feraheme. We have contracted with Integrated Commercialization Services, Inc., or ICS, to be our exclusive third party logisticsprovider to perform a variety of functions related to the sale and distribution of Feraheme, including services related to warehousing and inventorymanagement, distribution, chargeback processing, accounts receivable management and customer service call center management. As a result, most ofour inventory is stored at a single warehouse maintained by ICS. In addition, we have contracted with Catalent Pharma Solutions, LLC, or Catalent, toprovide certain labeling and packaging services for final Feraheme drug product. If ICS or Catalent are unable to provide uninterrupted supply chainservices or labeling and packaging services, respectively, we may incur substantial losses of sales to wholesalers or other purchasers of Feraheme. In addition, the packaging, storage and distribution of Feraheme requires significant coordination among our manufacturing, sales, marketing andfinance organizations and multiple third parties including our third party logistics provider, packaging and labeling provider, distributors, andwholesalers. In most cases, we do not currently have back-up suppliers or service providers to perform these tasks. If any of these third-partiesexperience significant difficulties in their respective processes, fail to maintain compliance with applicable legal or regulatory requirements, fail to meetexpected deadlines or otherwise do not carry out their contractual duties to us, or encounter physical or natural damages at their facilities, our ability todeliver Feraheme to meet commercial demand would be significantly impaired. The loss of any of our third party providers, together with a delay orinability to secure an alternate distribution source for end users, could cause the distribution of Feraheme to be delayed or interrupted, which wouldhave an adverse effect on our business, financial condition and results of operation.We may not be able to operate our manufacturing facility in compliance with current good manufacturing practices and other FDA regulations,which could result in a suspension of our ability to manufacture Feraheme, the loss of our Feraheme inventory, our inability to manufacturesufficient quantities of Feraheme to meet demand, or other unanticipated compliance costs. Our Cambridge, Massachusetts manufacturing facility is subject to current good manufacturing practices, or cGMP, regulations enforced by theFDA through periodic inspections to confirm such compliance. We must continually expend time, money and effort in production, record-keeping andquality assurance and control to ensure that our manufacturing facility meets the FDA's regulatory requirements. Failure to maintain ongoing compliancewith cGMP regulations and other applicable manufacturing requirements of various regulatory agencies could result in the FDA's issuance of WarningLetters, fines, the withdrawal or recall of Feraheme from the marketplace, total or partial suspension of Feraheme production, the loss of our Ferahemeinventory, suspension of the FDA's review of any future supplemental NDAs, enforcement actions, injunctions or criminal prosecution. If the FDAinspects our manufacturing facility and determines that we are not in compliance with cGMP regulations or we otherwise determine that we are not incompliance with these regulations, we could experience an inability to manufacture sufficient quantities of Feraheme to meet demand or incur28Table of Contentsunanticipated compliance expenditures, either of which could have an adverse impact on Feraheme sales, our potential profitability and the futureprospects of our business.We currently manufacture Feraheme at one manufacturing facility without a qualified second source manufacturer, and if we experience anydifficulties, disruptions or delays in the manufacturing process, we may not be able to produce sufficient quantities of Feraheme to meetcommercial demand or continue our Feraheme development efforts. We currently manufacture Feraheme for commercial use and for use in human clinical trials in our Cambridge, Massachusetts manufacturingfacility. Although we are working to establish and qualify second source manufacturing facilities, we currently have only one facility at which weproduce Feraheme. Our ability to manufacture Feraheme in sufficient quantities to meet commercial demand and our clinical development needs atacceptable costs is dependent on the uninterrupted and efficient operation of our manufacturing facility. If there are any difficulties, disruptions or delaysin the Feraheme manufacturing process, including quality control problems, we may experience manufacturing failures which could result in productdefects or shipment delays, recall or withdrawal of products previously shipped for commercial or clinical purposes, inventory write-offs or the inabilityto meet commercial demand for Feraheme in a timely and cost-effective manner. Furthermore, if we fail to continue to attract and retain key members ofour manufacturing or quality departments, we may be unable to manufacture sufficient quantities of Feraheme in a timely manner, which could delay orimpair our product sales and development efforts.If we cannot produce sufficient quantities of Feraheme at our manufacturing facility, we will need to rely on third party manufacturers, whichmay expose us to a number of risks. If we are unable to produce sufficient quantities of Feraheme to meet demand or we experience any manufacturing difficulties at our Cambridge,Massachusetts manufacturing facility, we will be required to enter into arrangements with third-party manufacturers. We are currently working toestablish and qualify second source manufacturing facilities for Feraheme, however we may not be able to enter into agreements with manufacturerswhose facilities and procedures comply with cGMP, regulations and other regulatory requirements on terms that are favorable to us, if at all. Even if wewere to reach agreement, the transition of the manufacturing process to a third party could take a significant amount of time. Any prolonged interruptionin our manufacturing operations could result in cancellations of orders or loss of product in the manufacturing process. Furthermore, use of second-source manufacturing facilities may increase the risk of certain problems, including cost overruns, process reproducibility, stability issues, the inabilityto deliver required quantities of product that conform to specifications in a timely manner, or the inability to manufacture Feraheme in accordance withcGMP. If we are unable to consistently manufacture our products on a timely basis because of these or other factors, we may not be able to meetanticipated commercial demand or our clinical development needs for Feraheme. As a result, we may lose sales and fail to generate increased revenuesand our clinical development programs may be delayed, which could have an adverse impact on our potential profitability and future business prospects.Our inability to obtain raw materials and our reliance on sole source suppliers could adversely impact our ability to manufacture sufficientquantities of Feraheme, which would have a severe adverse impact on our business. We currently purchase certain raw materials used to manufacture Feraheme from third-party suppliers. We do not have any long-term supplycontracts with these third parties. Some of these raw materials are procured from a single source with no qualified alternative supplier. We are in theprocess of identifying and qualifying additional third-party suppliers for these raw materials used to manufacture Feraheme. Third-party suppliers maycease to produce the raw materials used in Feraheme29Table of Contentsor otherwise fail to supply these raw materials to us or fail to supply these raw materials to us in sufficient quantities for a number of reasons, includingbut not limited to the following:•Unexpected demand for or shortage of raw materials; •Labor disputes or shortages; •Manufacturing difficulties; •Regulatory requirements or action; •Adverse financial developments at or affecting the supplier; or •Import or export problems. If any of our third-party suppliers cease to supply our raw materials for any reason, we will be unable to manufacture Feraheme or unable tomanufacture Feraheme in sufficient quantities until we are able to qualify an alternative source, which would adversely affect our ability to satisfycommercial demand and our clinical development needs for Feraheme. The qualification of an alternative source may require repeated testing of the new materials and generate greater expenses to us if materials that wetest do not perform in an acceptable manner. In addition, we sometimes obtain raw materials from one vendor only, even where multiple sources areavailable, to maintain quality control and enhance working relationships with suppliers, which could make us susceptible to price inflation by the solesupplier, thereby increasing our production costs. As a result of the high quality standards imposed on our raw materials, we may not be able to obtainraw materials of the quality required to manufacture Feraheme from an alternative source on commercially reasonable terms, or in a timely manner, if atall. Even if we are able to obtain raw materials from an alternative source, if these raw materials are not available in a timely manner or oncommercially reasonable terms, we would be unable to manufacture Feraheme, both for commercial sale and for use in our clinical trials, on a timelyand cost-effective basis. Any such difficulty in obtaining raw materials would severely hinder our ability to manufacture Feraheme and would have amaterial adverse impact on our ability to generate additional revenues and to achieve profitability.Our operating results will likely fluctuate so you should not rely on the results of any single quarter to predict how we will perform over time. Our future operating results will likely vary from quarter to quarter depending on a number of factors, some of which we cannot control, includingbut not limited to:•The timing and magnitude of our recognition of revenues from sales of Feraheme, including the recognition of net product revenuesassociated with purchases made under our Launch Incentive Program, which were deferred as of September 30, 2009; •The timing and magnitude of costs associated with the commercialization of Feraheme in the U.S., including costs associated withmaintaining our commercial infrastructure and executing our promotional and marketing strategy; •Changes in buying patterns of our wholesalers or distributors;30Table of Contents•The timing and magnitude of costs associated with our development of additional indications for Feraheme and our development ofFeraheme in countries outside of the U.S; •The timing and magnitude of costs associated with commercial-scale manufacturing of Feraheme, including costs associated withmaintaining commercial inventory and qualifying additional manufacturing capacities and second source suppliers; •Actual or anticipated difficulties, disruptions or delays associated with our manufacturing facility, packager, or supply chain anddistribution network; •Changes in laws and regulations concerning reimbursement for Feraheme, from government health administration authorities, privatehealth insurers and other third-party payors; •The initiation of litigation to enforce or defend any of our assets; and •Implementation of new or revised accounting or tax rules or policies. As a result of these and other factors, our quarterly operating results could fluctuate, and this fluctuation could cause the market price of ourcommon stock to decline. Results from one quarter should not be used as an indication of future performance.Wholesaler and distributor buying patterns and other factors may cause our quarterly results to fluctuate, and these fluctuations may adverselyaffect our short-term results. Our results of operations, including, in particular, product sales revenues, may vary from period to period due to a variety of factors, including thebuying patterns of our wholesalers and distributors, which vary from quarter to quarter. In the event wholesalers and distributors with whom we dobusiness determine to limit their purchases of our products, sales of our products could be adversely affected. For example, in advance of an anticipatedprice increase, customers may order Feraheme in larger than normal quantities which could cause sales of Feraheme to be lower in subsequent quartersthan they would have been otherwise. Further, any changes in purchasing patterns, inventory levels, increases in returns of Feraheme, delays inpurchasing products or delays in payment for products by one of our distributors could also have a negative impact on our revenue and results ofoperations.If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements prove inaccurate, our actualresults may vary from those reflected in our projections and accruals. Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States. Thepreparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of our assets,liabilities, revenues and expenses, the amounts of charges accrued by us, and the related disclosure of contingent assets and liabilities. On an ongoingbasis, our management evaluates our critical and other significant estimates and judgments, including among others, those related to revenue recognitionand related sales allowances, investments, reserves for doubtful accounts, equity-based compensation, accrued expenses and income taxes. We base ourestimates on market data, our observance of trends in our industry, and on various other assumptions that we believe to be reasonable under thecircumstances. If actual results differ from these estimates, there could be a material adverse effect on our financial results and the performance of ourstock. As part of our revenue recognition policy, our estimates of product returns, rebates and chargebacks, fees and other discounts require subjectiveand complex judgments due to the need to make estimates about matters that are inherently uncertain. Any significant differences between our actualresults and our estimates could negatively affect our financial position, results of operations and cash flows. In addition, to determine the requiredquantities of our products and the related manufacturing schedule, we also need to make significant judgments and estimates based on inventory31Table of Contentslevels, current market trends, anticipated sales, and other factors. Because of the inherent nature of estimates, there could be significant differencesbetween our estimates and the actual amount of product need. For example, the level of our access to wholesaler and distributor inventory levels andsales data, which varies based on the wholesaler or distributor, affects our ability to accurately estimate certain reserves included in our financialstatements. Any difference between our estimates and the actual amount of product demand could result in unmet demand or excess inventory, each ofwhich would adversely impact our financial results and results of operation.Our stock price has been and may continue to be volatile, and your investment in our stock could decline in value or fluctuate significantly. The market price of our common stock has been, and may continue to be, volatile, and your investment in our stock could decline in value orfluctuate significantly. Our stock price has ranged between $22.20 and $58.23 in the fifty-two week period through February 16, 2010. The stockmarket has from time to time experienced extreme price and volume fluctuations, particularly in the biotechnology and pharmaceuticals sectors, whichhave often been unrelated to the operating performance of particular companies. Various factors and events, many of which are beyond our control, mayhave a significant impact on the market price of our common stock. Factors which may affect the market price of our common stock include, amongothers:•Our ability to successfully commercialize Feraheme in the U.S.; •The timing and magnitude of Feraheme revenue and actual or anticipated fluctuations in our operating results; •Changes in or our failure to meet financial estimates published by securities analysts; •The availability of reimbursement coverage for Feraheme or changes in the reimbursement policies of governmental or private payors; •Public announcements of regulatory actions with respect to Feraheme or products or product candidates of our competitors; •Safety concerns related to Feraheme or products or product candidates of our competitors; •General market conditions; •Sales of large blocks of our common stock; •The status or results of clinical trials for Feraheme in indications other than CKD or products or product candidates of our competitors; •The acquisition or development of technologies, product candidates or products by us or our competitors; •Developments in patents or other proprietary rights by us or our competitors; •The initiation of litigation to enforce or defend any of our assets; and •Significant collaboration, acquisition, joint venture or similar agreements by us or our competitors. Thus, as a result of events both within and beyond our control, our stock price could fluctuate significantly or lose value rapidly.32Table of ContentsIf securities analysts downgrade our stock, cease coverage of us, or if our operating results do not meet analysts' forecasts and expectations, ourstock price could decline. The trading market for our common stock relies in part on the research and reports that industry or financial analysts publish about us and ourbusiness. Currently, ten financial analysts publish reports about us and our business. We do not control these or any other analysts. Furthermore, thereare many large, well-established, publicly traded companies active in our industry and market, which may mean that it is less likely that we will receivewidespread analyst coverage. In addition, our future operating results are subject to substantial uncertainty, and our stock price could declinesignificantly if we fail to meet or exceed analysts' forecasts and expectations, especially with respect to the timing and magnitude of Feraheme revenues,including the recognition of net product revenues associated with purchases made under our Launch Incentive Program, which were initially deferred asof September 30, 2009. If any of the analysts who cover us downgrade our stock or issue commentary or observations that are perceived by the marketto be adverse to us or our stock, our stock price would likely decline rapidly. If these analysts cease coverage of our company, we could lose visibilityin the market, which in turn could cause our stock price to decline.We have a history of net losses, and we may not be able to generate sufficient revenues to achieve and maintain profitability in the future. We have a history of significant operating losses, and we may not be profitable in the future or if we attain profitability, it may not be sustainable.In the past, we have financed our operations primarily from the sale of our equity securities, cash generated by our investing activities, and paymentsfrom our strategic partners. As of December 31, 2009, we had an accumulated deficit of approximately $281.7 million. Our losses are primarily theresult of costs incurred in research and development, including costs associated with our Feraheme and other development programs, costs associatedwith establishing and maintaining our sales and marketing infrastructure, and other selling, general and administrative costs. We expect to continue toincur significant expenses to manufacture, market and sell Feraheme as an IV iron replacement therapeutic in CKD patients in the U.S. and to furtherdevelop Feraheme for additional indications and in additional countries outside of the U.S. As a result, we will need to generate sufficient revenues infuture periods to achieve and maintain profitability. We anticipate that the vast majority of any revenue we generate in the near future will be from salesof Feraheme as an iron replacement therapeutic agent for CKD patients in the U.S. We have never independently marketed or sold any products, and wemay not be successful in marketing or selling Feraheme. If we are not successful in marketing and selling Feraheme, if revenues grow more slowlythan we anticipate or if our operating expenses exceed our expectations, our business, results of operations and financial condition could be materiallyadversely affected. In addition, if we are unable to achieve, maintain or increase profitability on a quarterly or annual basis, the market price of ourcommon stock may decline.We may need additional capital to achieve our business objectives. We have expended and will continue to expend substantial funds to successfully commercialize and develop Feraheme. As a result, we anticipatethat our expenses will increase and that our cash-burn rate will continue to increase in the near- and long-term. Our long-term capital requirements willdepend on many factors, including, but not limited to:•The magnitude of Feraheme sales and the timing of our receipt of cash from such sales; •Costs associated with the U.S. commercialization of Feraheme, including costs associated with maintaining our commercialinfrastructure and distribution network and executing our promotional and marketing strategy for Feraheme; •Costs associated with our development of additional indications for Feraheme;33Table of Contents•Costs associated with our pursuit of approval for Feraheme as an IV iron replacement therapeutic agent outside of the U.S.; •Costs associated with potential business development and in-licensing activities; •Costs associated with commercial-scale manufacturing of Feraheme, including costs associated with maintaining commercial inventoryand qualifying additional manufacturing capacities and second source suppliers; •Our ability to liquidate our investments in a timely manner and without significant loss; •The impact of the current volatility of the credit and capital markets upon the investments in our portfolio; •Our ability to establish additional development and marketing arrangements or to enter into alternative strategic relationships, ifnecessary; and •Our ability to raise additional capital on terms and within a timeframe acceptable to us, if necessary. We estimate that our existing cash resources, combined with cash we currently expect to receive from sales of Feraheme and earnings on ourinvestments, will be sufficient to finance our currently planned operations for at least the next twelve months. Thereafter, we may require additionalfunds or need to establish alternative strategic arrangements to continue our Feraheme commercialization efforts and development activities. We mayseek needed funding through arrangements with collaborative partners or through public or private equity or debt financings. We may not be able toobtain financing or to secure alternative strategic arrangements on acceptable terms or within an acceptable timeframe, if at all. Any additional equity financings or alternative strategic arrangements would be dilutive to our stockholders. In addition, the terms of any debtfinancing could greatly restrict our ability to raise additional capital and may provide rights and preferences to the investors in any such financing whichare not available to current stockholders. Our inability to raise additional capital on terms and within a timeframe acceptable to us when needed couldforce us to dramatically reduce our expenses and delay, scale back or eliminate certain of our activities and operations, including our commercializationand development activities, any of which would have a material adverse effect on our business, financial condition and future business prospects.We may enter into collaborations, in-licensing arrangements, or acquisition agreements that could disrupt our business, decrease ourprofitability, result in dilution to stockholders or cause us to incur debt or significant additional expense. As part of our business strategy, we intend to pursue collaboration and in-licensing opportunities, acquisitions of products or businesses, and/orstrategic alliances that we believe would be complementary to our existing business. We have limited experience with respect to these businessdevelopment activities. Any such strategic transactions by us could result in large and immediate write-offs or the incurrence of debt and contingentliabilities, any of which would adversely impact our operating results. Management of a license arrangement, collaboration, or other strategicarrangement and/or integration of an acquired asset or company may also disrupt our ongoing business, require management resources that otherwisewould be available for ongoing development of our existing business and our U.S. commercialization of Feraheme. We may not identify or completeany such transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated financial benefits of any suchtransaction. In addition, to finance any such strategic transactions, we may choose to issue shares of our common or preferred stock as consideration,which would result in dilution to our stockholders. Alternatively, it may be necessary for us to raise additional34Table of Contentsfunds through public or private financings, and such additional funds may not be available on terms that are favorable to us, if at all. In addition,proposing, negotiating and implementing collaborations, in-licensing arrangements or acquisition agreements may be a lengthy and complex process.Other companies, including those with substantially greater financial, marketing and sales resources, may compete with us for these arrangements, andwe may not be able to enter into such arrangements on acceptable terms or at all.The investment of our cash is subject to risks, which may cause losses or adversely affect the liquidity of these investments. At December 31, 2009, we had $50.1 million in cash and cash equivalents, $29.6 million in short-term investments, $49.0 million in long-terminvestments, and $0.8 million in Settlement Rights with respect to certain of our auction rate securities, or ARS. These investments are subject to generalcredit, liquidity, market and interest rate risks, which have been and may continue to be exacerbated by the U.S. sub-prime mortgage defaults and theensuing fallout. The recent disruptions in the credit and financial markets have negatively affected many industries, including those in which we invest,and we may realize losses in the fair value of certain of our investments or a complete loss of these investments, which would have an adverse effect onour results of operations, liquidity and financial condition. At December 31, 2009, we held a total of $57.5 million in fair market value of ARS, reflecting an impairment of approximately $7.9 millioncompared to the par value of these securities of $65.4 million. Of the $7.9 million impairment, approximately $7.1 million is considered a temporaryimpairment and was reported as an unrealized loss at December 31, 2009. The remaining $0.8 million represents a trading loss which was recognized inour consolidated statements of operations. In February 2008, our ARS began to experience failed auctions and have continued to experience failedauctions. Since that time, the continued uncertainty in the credit markets has caused almost all additional auctions with respect to our ARS to fail andprevented us from liquidating certain of our holdings of ARS because the amount of these securities submitted for sale has exceeded the amount ofpurchase orders for these securities. These auctions may continue to fail indefinitely, and there could be a further decline in value of these securities orany other securities, which may ultimately be deemed to be other-than-temporary. In the future, should we determine that these declines in value of ARSare other-than-temporary, we would recognize the credit-related portion of the loss to our consolidated statement of operations, which could be material.In addition, failed auctions will adversely impact the liquidity of our investments. Based on our ability to access our cash and other short-terminvestments, our expected operating cash flows, and our other sources of cash, we do not anticipate that the current lack of liquidity with respect to thesesecurities will materially affect our ability to operate our business in the ordinary course in the short term, however, we are uncertain when the currentliquidity issues relating to ARS will improve, if at all. The condition of the credit markets remains dynamic and unpredictable. As a result, we may experience a reduction in value or loss of liquiditywith respect to our investments. In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income wouldsuffer. Further, as part of our determination of the fair value of our investments, we consider credit ratings provided by independent investment ratingagencies as of the valuation date. These ratings are subject to change. For example, in February 2009 three of our ARS with a total par value of$8.7 million and one of our ARS with a par value of $5.0 million were downgraded by one of the major credit rating agencies to A3 and Baa1,respectively, from their previous rating of Aaa. In contrast, the ARS having a par a value of $5.0 million was re-affirmed as AAA by a different majorrating agency in January 2009. As the ratings of our ARS change we may be required to adjust our future valuation of our ARS which may adverselyaffect the value of these investments. These market35Table of Contentsrisks associated with our investment portfolio may have an adverse effect on our results of operations, cash position, liquidity and overall financialcondition.Our ability to use net operating loss carryforwards and tax credit carryforwards to offset future taxable income may be limited as a result of thesale of shares of our common stock in our January 2010 public offering or other past or future transactions involving our common stock. In general, under Section 382 of the Internal Revenue Code of 1986, as amended, a corporation that undergoes an "ownership change" is subject tolimitations on its ability to utilize its pre-change net operating losses and certain other tax assets to offset future taxable income. In general, an ownershipchange occurs if the aggregate stock ownership of certain stockholders increases by more than 50 percentage points over such stockholders' lowestpercentage ownership during the testing period, which is generally three years. An ownership change could limit our ability to utilize our net operatingloss and tax credit carryforwards for taxable years including or following such "ownership change." It is possible that the issuance of shares of ourcommon stock in our January 2010 public offering, together with certain other transactions involving our common stock within the testing period, willresult in an ownership change. Even if the issuance of our common stock in our recent offering does not result in an ownership change, this offeringwould significantly increase the likelihood that there would be an ownership change in the future (which ownership change could occur as a result oftransactions involving our common stock that are outside of our control, such as sales by existing stockholders). Limitations imposed on the ability touse net operating losses and tax credits to offset future taxable income could require us to pay U.S. federal income taxes earlier than would otherwise berequired if such limitations were not in effect and could cause such net operating losses and tax credits to expire unused, in each case reducing oreliminating the benefit of such net operating losses and tax credits. Similar rules and limitations may apply for state income tax purposes.The current credit and financial market conditions may exacerbate certain risks affecting our business. Over the past two years, the U.S. and global economies have taken a dramatic downturn as a result of the volatility of the credit markets and relatedfinancial crisis, as well as a variety of other factors including, among other things, extreme volatility in security prices, severely diminished liquidity andcredit availability, ratings downgrades of certain investments and declining valuations of others. The U.S. and certain foreign governments have takenunprecedented actions in an attempt to address and rectify these extreme market and economic conditions by providing liquidity and stability to thefinancial markets. If the actions taken by the U.S. and other governments are not successful, the continued economic decline may continue to negativelyaffect the liquidity of our investments, significantly impact our ability to raise capital, if needed, on a timely basis and on acceptable terms or at all, andcause our investments to substantially decline in value. Any of these could have a material adverse effect on our liquidity, cash position and the potentialfuture prospects of our business. In addition, we rely and intend to continue to rely on third-parties, including clinical research organizations, third-party manufacturers, third-partylogistics providers, packaging and labeling providers, wholesale distributors and certain other important vendors and consultants. As a result of thecurrent volatile and unpredictable global economic situation, there may be a disruption or delay in the performance or satisfaction of commitments to usby our third-party contractors and suppliers. For example, as a result of the current economic climate, our distributors, customers or suppliers mayexperience difficulty in obtaining the liquidity necessary to purchase inventory or raw materials, may begin to maintain lower inventory levels or couldbecome insolvent. If such third-parties are unable to adequately satisfy their contractual commitments to us in a timely manner, our business could beseverely adversely affected.36Table of ContentsIf we fail to comply with our reporting and payment obligations under governmental pricing programs, we could be required to reimbursegovernment programs for underpayments and could be required to pay penalties, sanctions and fines which could have a material adverse effecton our business, financial condition and results of operation. As a condition of reimbursement by various federal and state healthcare programs, we are required to calculate and report certain pricinginformation to federal and state healthcare agencies. For example, we are required to provide ASP information to CMS on a quarterly basis in order tocompute Medicare payment rates. Price reporting and payment obligations are highly complex and vary among products and programs. Our processesfor estimating amounts due under these governmental pricing programs involve subjective decisions, and as a result, our price reporting calculationsremain subject to the risk of errors and our methodologies for calculating these prices could be challenged under the Federal False Claims Act or otherlaws. If we become subject to investigations or other inquiries concerning our compliance with price reporting laws and regulations, we could berequired to pay or be subject to additional reimbursements, penalties, sanctions or fines, which could have a material adverse effect on our business,financial condition and results of operation.We are subject to ongoing regulatory review of Feraheme, and if we fail to comply with such continuing regulations, we could be subject topenalties up to and including the suspension of the manufacturing, marketing and sale of Feraheme. We are subject to ongoing FDA regulatory requirements and review pertaining to Feraheme's manufacture, labeling, packaging, adverse eventreporting, storage, advertising, promotion and record keeping. Failure to comply with such regulatory requirements or the later discovery of previouslyunknown problems with Feraheme or our manufacturing facility may result in restrictions on our ability to market and sell Feraheme, including itswithdrawal from the market. We may also be subject to additional sanctions, including but not limited to:•FDA Warning Letters; •Civil or criminal penalties; •Suspension or withdrawal of regulatory approvals; •Temporary or permanent closing of our manufacturing facilities; •Requirements to communicate with physicians and other customers about concerns related to actual or potential safety, efficacy, or otherissues involving Feraheme; •FDA-imposed label changes; •Implementation of an FDA-mandated REMS; •Restrictions on our continued manufacturing, marketing or sale of Feraheme; or •Recalls or a refusal by the FDA to consider or approve applications for additional indications. Any of these sanctions would have a material adverse impact on our ability to generate revenues and to achieve profitability.If we market or distribute our products in a manner that violates federal or state healthcare fraud and abuse laws, marketing disclosure laws orother federal or state laws and regulations, we may be subject to civil or criminal penalties. In addition to FDA and related regulatory requirements, we are subject to extensive federal and state healthcare regulation, including but not limitedto, the federal false claims act and the federal anti-kickback statute. False claims laws prohibit anyone from knowingly presenting, or causing to be37Table of Contentspresented for payment to third-party payors, including Medicare and Medicaid, false or fraudulent claims for reimbursed drugs or services, claims foritems or services not provided as claimed, or claims for medically unnecessary items or services. Anti-kickback laws make it illegal to solicit, offer,receive or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug, that isreimbursed by a state or federal program. We have developed and implemented a corporate compliance program based on what we believe are currentbest practices in the pharmaceutical industry, but we cannot guarantee that we, our employees, our consultants or our contractors are or will be incompliance with all federal and state regulations and/or laws. If we or our representatives fail to comply with any of these laws or regulations, a range offines, penalties and/or other sanctions could be imposed on us, including, but not limited to, restrictions on how we market and sell Feraheme,significant fines, exclusions from government healthcare programs, including Medicare and Medicaid, litigation, or other sanctions. Even if we are notdetermined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources andgenerate negative publicity, which could also have an adverse effect on our business, financial condition and results of operation. In recent years, several states and localities have enacted legislation requiring pharmaceutical companies to establish marketing and promotionalcompliance programs or codes of conduct and/or file periodic reports with the state or make periodic public disclosures on sales, marketing, pricing,clinical trials, and other activities. Similar legislation is being considered by additional states and by Congress. Many of these requirements are new anduncertain, and the penalties for failure to comply with these requirements are unclear. Compliance with these laws is difficult and time consuming, and ifwe are found to not be in full compliance with these laws, we may face enforcement actions, fines and other penalties, and we could receive adversepublicity which could have an adverse effect on our business, financial condition and results of operation. If we fail to comply with any federal or state laws or regulations governing our industry, we could be subject to a range of regulatory actions thatcould adversely affect our ability to commercialize Feraheme, harm or prevent sales of Feraheme, or substantially increase the costs and expenses ofcommercializing and marketing Feraheme, all of which could have a material adverse effect on our business, financial condition and results ofoperation.Our ability to grow revenues from sales of Feraheme will be limited if we do not obtain approval, or if we experience significant delays in ourefforts to obtain approval to market Feraheme for additional indications in the U.S. We have commenced or are pursuing additional clinical trials and plan to seek regulatory approval to market Feraheme in indications other thanCKD in the U.S. There is no guarantee that we will be successful in completing any clinical trials for additional indications in a timely manner or that, ifcompleted, the results of such clinical trials will demonstrate Feraheme to be safe and effective in such uses and/or patient populations. The FDA imposes substantial requirements on the development and production of all drug products. Before obtaining regulatory approval for thecommercial marketing and sale of Feraheme for additional indications, we must demonstrate through extensive human clinical trials that Feraheme issafe and efficacious for these new uses and in these new patient populations. Conducting clinical trials is a complex, time-consuming and expensiveprocess that requires adherence to a wide range of regulatory requirements. The FDA has substantial discretion in the approval process and may decidethat the results of our clinical trials are insufficient for approval or that Feraheme is not effective or safe in indications other than CKD. Clinical andother data is often susceptible to varying interpretations, and many companies that have believed their product candidates performed satisfactorily inclinical trials have nonetheless failed to obtain FDA approval for their products.38Table of Contents The FDA could also determine that our clinical trials and/or our manufacturing processes were not properly designed, were not conducted inaccordance with federal laws and regulations, or were otherwise not properly managed. In addition, under the FDA's current good clinical practicesregulations, or cGCP, we are responsible for conducting, recording and reporting the results of clinical trials to ensure that the data and results arecredible and accurate and that the trial participants are adequately protected. The FDA may conduct inspections of clinical investigator sites which areinvolved in our clinical development programs to ensure their compliance with cGCP regulations. If the FDA determines that we, our contract researchorganizations or our study sites fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemedunreliable and the FDA may disqualify certain data generated from those sites or require us to perform additional clinical trials before approving ourmarketing applications, which could adversely impact our ability to obtain approval for Feraheme in indications other than CKD. Any such deficiencyin the design, implementation or oversight of our clinical development programs could cause us to incur significant additional costs, experiencesignificant delays in our efforts to obtain regulatory approval for Feraheme in indications other than CKD, or even prevent us from obtaining regulatoryapproval for Feraheme for additional indications. This would, in turn, materially adversely impact our cash position, our ability to increase revenues,our ability to achieve profitability, and the future prospects of our business. In addition, our ability to complete our planned clinical trials in a timely manner depends on a number of factors, including:•Our ability to reach agreement with the FDA on a trial design in a timely manner; •Our ability to identify and enter into contracts with prospective clinical sites in a timely manner; •The rate of patient enrollment; and •The ability of our contract research organizations to perform their oversight responsibilities and meet expected deadlines. Any failure by us to obtain approval for additional Feraheme indications in the U.S. in a timely manner may limit the commercial success ofFeraheme and our ability to grow our revenues.Our ability to grow revenues from sales of Feraheme will be limited if we do not obtain approval, or if we experience significant delays in ourefforts to obtain approval to market Feraheme in countries outside of the U.S. To the extent we wish to manufacture, market or sell Feraheme in foreign countries, we will need to comply with foreign regulatory requirements,which vary widely from country to country and may in some cases be more rigorous than requirements in the U.S. Foreign regulatory agents mayrequire additional studies or studies designed with different clinical endpoints and/or comparators than those which we have already completed. Thetime required for approval may also be longer or shorter than in the U.S. In addition, in order to increase the number of patients available for enrollmentin our clinical trials, we may conduct trials in geographies outside the U.S. We have no experience conducting clinical trials outside the U.S., and,therefore, we will need to expend substantial time and resources to identify and familiarize ourselves with the regulatory requirements of such foreigncountries. Any failure by us to obtain approval for Feraheme indications outside of the U.S. in a timely manner may limit the commercial success ofFeraheme and our ability to grow our revenues.We rely on third parties in the conduct of our clinical trials, and if they fail to fulfill their obligations, our development plans may be adverselyaffected. We rely on independent clinical investigators, contract research organizations and other third-party service providers to assist us in managing,monitoring and otherwise carrying out our clinical trials. We have and we plan to continue to contract with certain third-parties to provide certainservices, including39Table of Contentssite selection, enrollment, monitoring and data management services. Although we depend heavily on these parties, we do not control them and,therefore, we cannot be assured that these third-parties will adequately perform all of their contractual obligations to us. If our third-party serviceproviders cannot adequately fulfill their obligations to us in a timely manner and on a satisfactory basis or if the quality and accuracy of our clinical trialdata is compromised due to failure to adhere to our protocols or regulatory requirements or if such third-parties otherwise fail to adequately dischargetheir responsibilities or meet deadlines, our development plans may be delayed or terminated.If we do not effectively manage our growth, our ability to commercialize Feraheme, pursue opportunities and expand our business could beadversely affected. We have experienced significant growth, which has placed and may continue to place a substantial strain on our management, employees, facilitiesand resources. In anticipation of the approval and U.S. commercialization of Feraheme, we rapidly expanded our marketing, sales, manufacturing,regulatory, medical affairs, finance, development, and compliance capabilities. As our operations continue to expand, we will also need to manageadditional relationships with various collaborative partners, suppliers and other third parties. In addition, we will need to continue to improve ouroperational and financial systems, train and manage our expanding workforce, and maintain close coordination among our various departments. We maynot be able to accomplish these tasks, and our failure to accomplish any one of them could prevent us from successfully commercializing Feraheme,pursuing new business opportunities, or expanding our business, any one of which could adversely impact our future business prospects.Our success depends on our ability to attract and retain key employees. Because of the specialized nature of our business, our success depends to a significant extent on the continued service of our Chief ExecutiveOfficer and President, Brian J.G. Pereira, MD, our other executive officers and on our ability to continue to attract, retain and motivate qualifiedmanagerial, scientific, medical and sales personnel. We have entered into employment agreements with our senior executives but such agreements do notguarantee that these executives will remain employed by us for any significant period of time, or at all. If we are unable to retain these personnel, or welose the services of our key personnel for any reason, our Feraheme development and commercialization efforts could be adversely impacted. Furthermore, our expansion into areas and activities requiring additional expertise, such as commercial-scale manufacturing, marketing and sales,and late-stage development has required the addition of new management personnel and the development of additional expertise by existing managementpersonnel. There is intense competition for qualified personnel in the areas of our activities, and we may not be able to continue to attract and retain thequalified personnel necessary for the development of our business. Our failure to attract and retain such personnel or to develop such expertise couldimpose significant limits on our business operations and hinder our ability to successfully and efficiently commercialize Feraheme and complete ourdevelopment projects.Our success depends on our ability to maintain the proprietary nature of our technology. We rely on a combination of patents, trademarks, copyrights and trade secrets in the conduct of our business. The patent positions ofpharmaceutical and biopharmaceutical firms are generally uncertain and involve complex legal and factual questions. We may not be successful or timelyin obtaining any patents for which we submit applications. The breadth of the claims obtained in our patents may not provide significant protection forour technology. The degree of protection afforded by patents for licensed technologies or for future discoveries may not be adequate to protect ourproprietary technology. The patents issued to us may not provide us with any competitive advantage. In addition, there is a risk that others willindependently develop or duplicate similar technology or products or circumvent the patents issued to us.40Table of Contents Our U.S. Feraheme patents are currently scheduled to expire in 2020. These and any other patents issued to us may be contested or invalidated.Future patent interference proceedings involving our patents may harm our ability to commercialize Feraheme. Claims of infringement or violation ofthe proprietary rights of others may be asserted against us. If we are required to defend against such claims or to protect our own proprietary rightsagainst others, it could result in substantial costs to us and the distraction of our management. An adverse ruling in any litigation or administrativeproceeding could prevent us from marketing and selling Feraheme, limit our development and commercialization of Feraheme, or harm our competitiveposition and result in additional significant costs. In addition, any successful claim of infringement asserted against us could subject us to monetarydamages or injunction preventing us from making or selling Feraheme. We also may be required to obtain licenses to use the relevant technology. Suchlicenses may not be available on commercially reasonable terms, if at all. The laws of foreign countries may not protect our intellectual property rights to the same extent as do the laws of the U.S. In countries where wedo not have or have not applied for patents on Feraheme, we may be unable to prevent others from developing or selling similar products. In addition,in jurisdictions outside the U.S. where we have patent rights, we may be unable to prevent unlicensed parties from selling or importing products ortechnologies derived elsewhere using our proprietary technology. We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop andmaintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our corporate partners, collaborators, employeesand consultants. These agreements, however, may be breached. We may not have adequate remedies for any such breaches, and our trade secrets mightotherwise become known or might be independently discovered by our competitors. In addition, we cannot be certain that others will not independentlydevelop substantially equivalent or superseding proprietary technology, or that an equivalent product will not be marketed in competition withFeraheme, thereby substantially reducing the value of our proprietary rights.If we identify a material weakness in our internal controls over financial reporting, our ability to meet our reporting obligations and the tradingprice of our stock could be negatively affected. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonablepossibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Accordingly, amaterial weakness increases the risk that the financial information we report contains material errors. We regularly review and update our internal controls, disclosure controls and procedures, and corporate governance policies. In addition, we arerequired under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting. Any system of internal controls,however well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that theobjectives of the system are met. If we, or our independent registered accounting firm, determine that our internal controls over our financial reportingare not effective, or we discover areas that need improvement in the future, these shortcomings could have an adverse effect on our business andfinancial results, and the price of our common stock could be negatively affected. If we cannot conclude that we have effective internal control over our financial reporting, or if our independent registered accounting firm is unableto provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in thereliability of our financial statements, which could lead to a decline in our stock price. Failure to comply with reporting requirements could also subjectus to sanctions and/or investigations by the Securities and Exchange Commission, NASDAQ or other regulatory authorities.41Table of ContentsWe are exposed to a number of different potential liability claims, and we may not be able to maintain or obtain sufficient insurance coverage toprotect our cash and other assets. The administration of our products to humans, whether in clinical trials or after approved commercial usage, may expose us to liability claims.Although we maintain product liability insurance coverage for claims arising from the use of our products in clinical trials and commercial use, coverageis expensive and we may not be able to maintain sufficient insurance at a reasonable cost, if at all. Product liability claims, whether or not they havemerit, could decrease demand for Feraheme, divert the attention of our management and key personnel from our core business, require us to spendsignificant time and money in litigation or pay significant damages, all of which could prevent or interfere with the commercialization and developmentof Feraheme and adversely affect our business. Claims of this nature could also subject us to product recalls or harm our reputation, which coulddamage our position in the market.We could be subject to class action litigation due to stock price volatility, which, if it occurs, will distract our management and could result insubstantial costs or large judgments against us. The stock market in general has recently experienced extreme price and volume fluctuations. In addition, the market prices of securities ofcompanies in the biopharmaceutical industry have been extremely volatile and have experienced fluctuations that have often been unrelated ordisproportionate to the operating performance of these companies. These fluctuations could adversely affect the market price of our common stock. Inthe past, securities class action litigation has often been brought against companies following periods of volatility in the market prices of their securities.We may be the target of similar litigation in the future. Securities litigation could result in substantial costs and divert our management's attention andresources, which could cause serious harm to our business, operating results and financial condition.Our shareholder rights plan, certain provisions in our charter and by-laws, certain contractual relationships and certain Delaware lawprovisions could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may preventattempts by our stockholders to replace or remove our current members of our Board of Directors. In 2009 we adopted a shareholder rights plan, the provisions of which are intended to deter a hostile takeover by making any proposed hostileacquisition of us more expensive and less desirable to a potential acquirer by enabling our shareholders (other than the potential hostile acquiror) topurchase significant amounts of additional shares of our common stock at dilutive prices. The rights issued pursuant to our shareholder rights planbecome exercisable generally upon the earlier of 10 days after a person or group acquires 20% or more of our outstanding common stock or 10business days after the announcement by a person or group of an intention to acquire 20% of our outstanding common stock via tender offer or similartransaction. The shareholder rights plan could delay or discourage transactions involving an actual or potential change in control of us or ourmanagement, including transactions in which stockholders might otherwise receive a premium for their shares over then current prices. In addition, certain provisions in our certificate of incorporation and our by-laws may discourage, delay or prevent a change of control or takeoverattempt of our company by a third-party as well as substantially impede the ability of our stockholders to benefit from a change of control or effect achange in management and board of directors. These provisions include:•The ability of our Board of Directors to increase or decrease the size of the Board without stockholder approval; •Advance notice requirements for the nomination of candidates for election to our Board of Directors and for proposals to be broughtbefore our annual meeting of stockholders;42Table of Contents•The authority of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder approval; •Non-cumulative voting for directors; and •Limitations on the ability of our stockholders to call special meetings of stockholders. As a Delaware corporation, we are subject to the provisions of Section 203 of the Delaware General Corporation Law which prevents us fromengaging in any business combination with any "interested stockholder," which is defined generally as a person that acquires 15% or more of acorporation's outstanding voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder,unless the business combination is approved in the manner prescribed in Section 203. These provisions could have the effect of delaying or preventing achange of control, whether or not it is desired by, or beneficial to, our stockholders. In addition to the above factors, an acquisition of our company could be made more difficult by employment agreements we have in place with ourexecutive officers, as well as a company-wide change of control policy which provide for severance benefits as well as the full acceleration of vesting ofany outstanding options or restricted stock units in the event of a change of control and subsequent termination of employment. Further, our Amendedand Restated 2007 Equity Incentive Plan generally permits our Board of Directors to provide for the acceleration of vesting of options granted underthat plan in the event of certain transactions that result in a change of control.We are subject to environmental laws and potential exposure to environmental liabilities. Because we use certain hazardous materials in the production of our products, we are subject to various federal, state and local environmental lawsand regulations that govern our operations, including the import, handling and disposal of non-hazardous and hazardous wastes, and emissions anddischarges into the environment. Failure to comply with these laws and regulations could result in costs for corrective action, penalties or the impositionof other liabilities. We also are subject to laws and regulations that impose liability and clean-up responsibility for releases of hazardous substances intothe environment. Under certain of these laws and regulations, a current or previous owner or operator of property may be liable for the costs ofremediating the release or spill of hazardous substances or petroleum products on or from its property, without regard to whether the owner or operatorknew of, or caused, the contamination, and such owner or operator may incur liability to third parties impacted by such contamination. The presence of,or failure to remediate properly the release or spill of, these substances could adversely affect the value of, and our ability to transfer or encumber, ourreal property.43Table of ContentsITEM 1B. UNRESOLVED STAFF COMMENTS: None.ITEM 2. PROPERTIES: In May 2008, we entered into a lease agreement for certain real property located at 100 Hayden Avenue, Lexington, Massachusetts for use as ourprincipal executive offices. The term of the lease began on May 22, 2008 and will continue until August 31, 2016 with two successive five yearextension terms at our option. The aggregate size of rentable floor area for the offices is 55,924 square feet, and the rent for the initial term commencedin February 2009. During any extension term, the base rent will be an amount agreed upon by us and the landlord. In addition to base rent, we are also required topay a proportionate share of the landlord's annual operating costs. On May 20, 2008, in connection with our facility lease, we delivered to the landlord asecurity deposit of approximately $0.5 million in the form of an irrevocable letter of credit. The cash securing this letter of credit is classified on ourbalance sheet as a long-term asset and is restricted in its use. Our manufacturing and quality operations are located in a building we own comprised of approximately 25,000 square feet located at 61 MooneyStreet, Cambridge, Massachusetts. If we decide to expand our manufacturing capacity, we might not be able to do so on a timely basis, if at all, becausethe acquisition of, and required regulatory approvals for, additional pharmaceutical manufacturing space can be time-consuming and expensive.ITEM 3. LEGAL PROCEEDINGS: On February 11, 2010, we submitted to FINRA Dispute Resolution, Inc. an arbitration claim against our broker-dealer, Jefferies & Company, Inc.,or Jefferies, and two former Jefferies employees, Anthony J. Russo, and Robert A. D'Addario, who managed our cash account with Jefferies. Weallege that Jefferies, Russo and D'Addario wrongfully marketed and sold a balance of $54.1 million in unsuitable auction rate securities, or ARS, to usfrom September 2007 through January 2008. We further allege that Jefferies, Russo and D'Addario misrepresented or omitted material facts concerningthe nature and risks of ARS, which were inconsistent with our investment objectives to maintain liquidity and flexibility in our portfolio. We primarilyseek damages from Jefferies, Russo and D'Addario in the amount of $54.1 million, the total par value of the ARS that Jefferies, Russo and D'Addariowrongfully marketed and sold to us. We may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities, including claims ordisputes related to patents that have been issued or that are pending in the field of research on which we are focused. We are not aware of any materialclaims against us at December 31, 2009.ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS: None.44Table of ContentsPART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUERPURCHASES OF EQUITY SECURITIES: Market Information Our common stock trades on the NASDAQ Global Market, or NASDAQ, under the trading symbol "AMAG." On February 16, 2010, theclosing price of our common stock, as reported on the NASDAQ, was $37.71 per share. The following table sets forth, for the periods indicated, thehigh and low sale prices per share for our common stock as reported on the NASDAQ.Stockholders On February 16, 2010, we had approximately 115 stockholders of record of our common stock, and we believe that the number of beneficialholders of our common stock was approximately 5,000 based on responses from brokers to a search conducted by Broadridge Financial Solutions, Inc.on our behalf.Dividends We have never declared or paid a cash dividend on our common stock. We currently anticipate that we will retain all of our earnings for use in thedevelopment of our business and do not anticipate paying any cash dividends in the foreseeable future.Repurchases of Equity Securities There were no purchases by us, or any affiliated purchaser of ours, of our equity securities that are registered pursuant to Section 12 of theSecurities Exchange Act of 1934, as amended, during the three months ended December 31, 2009.Securities Authorized for Issuance Under Equity Compensation Plans See Part III, Item 12 for information regarding securities authorized for issuance under our equity compensation plans. Such information isincorporated by reference to our definitive proxy statement pursuant to Regulation 14A, to be filed with the U.S. Securities and Exchange Commissionnot later than 120 days after the close of our year ended December 31, 2009.45 High Low Year Ended December 31, 2009 First quarter $39.75 $22.20 Second quarter $57.19 $36.09 Third quarter $58.23 $39.24 Fourth quarter $45.14 $33.76 Year Ended December 31, 2008 First quarter $66.94 $33.00 Second quarter $43.36 $33.91 Third quarter $49.39 $33.28 Fourth quarter $42.28 $18.33 Table of ContentsITEM 6. SELECTED FINANCIAL DATA: The following table sets forth selected financial data as of and for the years ended December 31, 2009, 2008 and 2007, the three months endedDecember 31, 2006, and the years ended September 30, 2006 and 2005. The information below includes our transition period for the three monthsended December 31, 2006 as a result of our Board of Directors voting in May 2007 to change our fiscal year end from September 30 to December 31.The selected financial data set forth below has been derived from our audited financial statements. This information should be read in conjunction withthe financial statements and the related notes thereto included in Part II, Item 8 of this Annual Report on Form 10-K, Management's Discussion andAnalysis of Financial Condition and Results of Operations included in Part II, Item 7 of this Annual Report on Form 10-K, and other financialinformation included elsewhere in this Annual Report on Form 10-K. For the Years EndedDecember 31, For theThree MonthsEndedDecember 31, For the Years EndedSeptember 30, 2009 2008 2007 2006 2006 2005 (in thousands, except per share data) Statement ofOperationsData Revenues: Product sales,net $16,482 $751 $1,208 $353 $1,449 $890 License fees 516 959 1,096 222 907 1,281 Royalties 180 228 248 44 317 274 Total revenues 17,178 1,938 2,552 619 2,673 2,445 Costs andExpenses: Cost of productsales 1,013 292 320 287 273 204 Research anddevelopmentexpenses* 36,273 31,716 24,236 6,393 21,294 12,037 Selling, generalandadministrativeexpenses* 77,829 49,536 20,396 2,197 8,011 3,338 Total costsandexpenses 115,115 81,544 44,952 8,877 29,578 15,579 Other Income(Expense): Interest anddividendincome, net 3,154 9,139 12,506 818 1,575 419 Gains (losses)oninvestments,net 942 (3,024) — — — — Fair valueadjustment ofsettlementrights (778) 1,566 — — — — Litigationsettlement — — (4,000) — — — Other income(expense), net — — — — (35) — Total otherincome(expense) 3,318 7,681 8,506 818 1,540 419 Net loss beforeincome taxes (94,619) (71,925) (33,894) (7,440) (25,365) (12,715)Income taxbenefit 1,268 278 — — — — Net loss $(93,351)$(71,647)$(33,894)$(7,440)$(25,365)$(12,715) Net loss per share—basic anddiluted: $(5.46)$(4.22)$(2.15)$(0.60)$(2.31)$(1.47) Weighted average 46sharesoutstandingused tocompute netloss per share: Basic anddiluted 17,109 16,993 15,777 12,383 10,964 8,634 December 31, September 30, 2009 2008 2007 2006 2006 2005 (in thousands) Balance Sheet Data Working capital (current assets less current liabilities) $85,168 $149,918 $282,196 $149,474 $33,623 $21,211 Total assets $184,619 $231,955 $294,851 $162,342 $47,371 $28,292 Long-term liabilities $4,081 $4,149 $879 $1,688 $1,795 $2,585 Stockholders' equity $142,977 $213,414 $285,954 $152,277 $36,075 $22,379 *We adopted accounting guidance related to equity-based compensation expense effective October 1, 2005. Accordingly, the period ended September 30, 2005does not reflect equity-based compensation expense related to employee stock awards.Table of ContentsITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS: Overview AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company that utilizes our proprietarytechnology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid inthe diagnosis of cancer and cardiovascular disease. We currently manufacture and sell two approved products, Feraheme® (ferumoxytol) Injection forintravenous, or IV, use and GastroMARK®. On June 30, 2009, Feraheme was approved for marketing in the U.S. by the U.S. Food and Drug Administration, or the FDA, for use as an IViron replacement therapy for the treatment of iron deficiency anemia, or IDA, in adult patients with chronic kidney disease, or CKD. We market and sellFeraheme through our own commercial organization, consisting of approximately 120 professionals, including an 80-person specialized sales force andaccount management and reimbursement teams. We sell Feraheme primarily to authorized wholesalers and specialty distributors and began commercialsale of Feraheme in the U.S. in July 2009. In November 2009, the Centers for Medicare & Medicaid Services assigned Feraheme two unique Q-codes, one for the treatment of IDA in end-stage renal disease patients undergoing dialysis and one for the treatment of IDA in non-end-stage renal disease patients. These Q-codes, which aretemporary product-specific codes that enable automated processing of Feraheme-related claims, became effective on January 1, 2010. For the year ended December 31, 2009, we recognized net product sales of Feraheme of $15.8 million, including approximately $1.3 million of the$11.5 million in deferred product revenues we had recorded in the third quarter of 2009. During the third quarter of 2009, shortly after the launch ofFeraheme, we implemented a Launch Incentive Program under which certain dialysis organizations purchased Feraheme directly from us. Thisprogram provided certain customers with, among other things, discounted pricing and expanded rights of return. As a result, we deferred revenuesassociated with this program which we will recognize as revenues as the participating organizations utilize their Feraheme inventory. We expect thatutilization of the remaining deferred product revenues from the Launch Incentive Program will increase going forward as each Launch IncentiveProgram customer has begun to use Feraheme. In December 2009, we submitted draft protocols for two proposed clinical trials to meet our FDA post-approval Pediatric Research Equity Actrequirement to support pediatric labeling of Feraheme. In 2010, we intend to initiate these two randomized, active controlled pediatric studies in childrenwith IDA. One study will be in dialysis dependent CKD patients, and the other will be in CKD patients not on dialysis. Each study will assess thesafety and efficacy of Feraheme treatment as compared to oral iron in approximately 144 children. We also plan to advance our Feraheme clinical development program in adults by initiating two Phase III multi-center clinical trials in mid-2010 toassess Feraheme for the treatment of IDA in a broad range of patients, which may include women with abnormal uterine bleeding, or AUB, patientswith cancer and gastrointestinal diseases and postpartum women, for whom oral iron is unsatisfactory. One study will assess the efficacy and safety oftwo doses of 510 milligrams each of Feraheme compared to placebo in a total of approximately 800 patients with IDA. A second study will assess theefficacy and safety of two doses of 510 milligrams each of Feraheme compared to a total dose of 1,000 milligrams of an IV iron sucrose product in atotal of approximately 600 patients with IDA. Further, we intend to initiate an open label extension study enrolling patients from the placebo controlledstudy who will be followed for six months and will be eligible to receive two doses of 510 milligrams each of Feraheme whenever they meet treatmentcriteria.47Table of Contents We continue to evaluate our strategy for seeking approval for Feraheme as an IV iron replacement therapeutic agent in countries outside of theU.S. The commercial opportunity for Feraheme as an IV iron replacement therapeutic agent varies from country to country, and in determining whichadditional markets outside of the U.S. we intend to enter, we are assessing factors such as potential pricing and reimbursement, the role of iron inmedical treatment protocols, and the regulatory requirements of each country. We expect to file a Marketing Authorization Application, or MAA, forFeraheme for the treatment of IDA in CKD patients with the European Medicines Agency, or EMEA, in mid-2010. In the fourth quarter of 2009, wereceived approval from the EMEA for our Pediatric Investigation Plan, which is a prerequisite for the submission of our Feraheme MAA. OurPediatric Investigation Plan includes the two pediatric studies required to meet our Pediatric Research Equity Act requirement and two additionalpediatric studies requested by the EMEA. To further support our MAA, we have initiated a global, randomized, Phase IV multi-center, active controlledtrial with approximately 150 adult CKD patients both on dialysis and not on dialysis. This study will assess the safety and efficacy of two doses of 510milligrams each of Feraheme compared to a total dose of 1,000 milligrams of an IV iron sucrose product. In December 2009, we filed a New Drug Submission for Feraheme to treat IDA in patients with CKD with the Therapeutic Products Directorateof Health Canada, or Health Canada, the federal authority that regulates pharmaceutical drugs and medical devices for human use in Canada. InFebruary 2010, we received a Screening Deficiency Notice from Health Canada requesting certain clarifications and additional documents. We havesubmitted our response to Health Canada and believe that all of these items are readily addressable. In addition, in December 2009, our partner in China,3SBio Inc., or 3SBio, filed an application with the Chinese State Food and Drug Administration, or the SFDA, to obtain approval to begin aregistrational clinical trial necessary to file for marketing approval in China. Once approved by the SFDA, 3SBio plans to commence a multi-centerrandomized efficacy and safety study in China involving approximately 200 CKD patients. In addition to its use for the treatment of IDA, Feraheme may also be useful as a vascular enhancing agent in magnetic resonance imaging, orMRI. In August 2008, the FDA granted Fast Track designation to Feraheme with respect to its development as a diagnostic agent for vascular-enhanced MRI for the assessment of peripheral arterial disease, or PAD, in patients with CKD. We have enrolled over two-thirds of our 108 patientPhase II study of Feraheme in vascular-enhanced MRI for the detection of clinically significant arterial stenosis or occlusion, or narrowing or blockingof the arteries. GastroMARK, our oral contrast agent used for delineating the bowel in MRI, is approved and marketed in the U.S., Europe, and other countriesthrough our marketing partners. Sales of GastroMARK by our marketing partners have been at their current levels for the last several years, and we donot expect sales of GastroMARK to change materially. Feridex I.V.®, our liver contrast agent, had been marketed and sold in the U.S., Europe and other countries for a number of years through ourmarketing partners. In November 2008, we decided to cease manufacturing Feridex I.V. Accordingly, we have terminated all of our agreements with ourmarketing partners for Feridex I.V. throughout the world and do not intend to continue commercializing Feridex I.V. We recorded no product salesrevenues associated with Feridex I.V. in 2009 and do not expect to recognize any Feridex I.V. related revenues in 2010. In the past, we have devoted substantially all of our resources to our research and development programs and, more recently, we have also incurredsubstantial costs related to the commercialization of Feraheme. Prior to the commercial launch of Feraheme, we financed our operations primarily fromthe sale of our equity securities, cash generated by our investing activities, and payments from our strategic partners. At December 31, 2009, ouraccumulated deficit was approximately $281.7 million. We expect to continue to incur significant expenses to manufacture, market and sell Feraheme asan iron replacement therapeutic in CKD patients in the U.S. and to further develop Feraheme for additional indications and in additional countriesoutside of the U.S. In the second half of 2009, we48Table of Contentsbegan to derive revenues from product sales of Feraheme. We now expect to fund our future operations in part from the sale of Feraheme in addition tothe sale of our equity securities, cash generated by our investing activities, and payments from our strategic partners. In January 2010, we sold 3,600,000 shares of our common stock, $0.01 par value per share, in an underwritten public offering at a price to thepublic of $48.25 per common share, resulting in gross proceeds of approximately $173.7 million. Net proceeds to us after deducting fees, commissionsand other expenses related to the offering were approximately $165.6 million. The shares were issued pursuant to a shelf registration statement onForm S-3 which became effective upon filing.Results of OperationsYear Ended December 31, 2009 Compared to Year Ended December 31, 2008Revenues Total revenues were $17.2 million and $1.9 million for the years ended December 31, 2009 and 2008, respectively, representing an increase ofapproximately $15.3 million, or greater than 100%. The increase in revenues was primarily due to product sales of Feraheme following its FDAapproval and commercial launch in mid-2009. The following table sets forth customers who represented 10% or more of our revenues for the years ended December 31, 2009 and 2008. Noother company accounted for more than 10% of our total revenues in either year. Our revenues for the years ended December 31, 2009 and 2008 consisted of the following (in thousands):Net Product Sales Net product sales for the years ended December 31, 2009 and 2008 consisted of the following (in thousands):49 Years Ended December 31, 2009 2008 AmerisourceBergen Drug Corporation 46% — Metro Medical Supply, Inc. 28% — Bayer Healthcare Pharmaceuticals <10% 53%Guerbet S.A. <10% 24%Covidien, Ltd. <10% 17% Years Ended December 31, 2009 2008 $ Change % Change Product sales, net $16,482 $751 $15,731 >100%License fees 516 959 (443) -46%Royalties 180 228 (48) -21% Total $17,178 $1,938 $15,240 >100% Years Ended December 31, 2009 2008 $ Change % Change Feraheme $15,774 $— $15,774 N/A GastroMARK 708 398 310 78%Feridex I.V. — 333 (333) -100%Other — 20 (20) -100% Total $16,482 $751 $15,731 >100% Table of Contents The $15.7 million increase in net product sales was primarily due to the FDA approval of Feraheme on June 30, 2009 and its subsequent U.S.commercial launch. Our product sales may fluctuate from period to period as a result of factors such as wholesaler demand forecasts and buyingdecisions as well as end user demand, which can create uneven purchasing patterns by our customers. Our product sales may also fluctuate as the resultof changes or adjustments to our reserves or changes in government or customer rebates. We recognize net product sales in accordance with current accounting guidance related to the recognition, presentation and disclosure of revenue infinancial statements, which outlines the basic criteria that must be met to recognize revenue and provides guidance for disclosure of revenue in financialstatements. We recognize revenue when:•persuasive evidence of an arrangement exists; •delivery of product has occurred or services have been rendered; •the sales price charged is fixed or determinable; and •collection is reasonably assured. We record product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and other rebates, distributor,wholesaler and group purchasing organization, or GPO, fees, and product returns as a reduction of revenue in our consolidated statement of operationsat the time product sales are recorded. Calculating these gross-to-net sales adjustments involves estimates and judgments based primarily on actualFeraheme sales data and forecasted customer buying patterns blended with historical experience of products similar to Feraheme sold by others. Inaddition, we also monitor our distribution channel to determine whether additional allowances or accruals are required based on inventory in our saleschannel. There were no product sales allowances or accruals for the year ended December 31, 2008. For further details related to our revenuerecognition and related sales allowances policy refer to our critical accounting policies included in Part II, Item 7 "Management's Discussion andAnalysis of Financial Condition and Results of Operations" of this Annual Report on Form 10-K. An analysis of our product sales allowances andaccruals for the year ended December 31, 2009 is as follows (in thousands): An analysis of the amount of, and change in, reserves for 2009 is as follows (in thousands):50 December 31, 2009 Product sales allowances and accruals: Discounts and chargebacks $804 Government and other rebates 4,329 Returns 463 Total product sales allowances and accruals $5,596 Total net product sales $16,482 Total gross product sales $22,078 Total product sales allowances and accruals as a percent of total gross product sales 25% Discounts Rebatesand Fees Returns Total Balance at December 31, 2008 $— $— $— $— Current provisions relating to sales in current year 804 4,329 463 5,596 Other provisions relating to deferred revenue — 1,119 — 1,119 Adjustments relating to prior years — — — — Payments/returns relating to sales in current year (305) (254) — (559) Payments/returns relating to sales in prior years — — — — Other adjustments — — — — Balance at December 31, 2009 $499 $5,194 $463 $6,156 Table of Contents Product sales allowances and accruals are comprised of both direct and indirect fees, discounts and rebates. Direct fees, discounts and rebates arecontractual 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 dialysisorganizations, physicians, clinics, hospitals, and GPOs that typically do not purchase products directly from us but rather from wholesalers andspecialty distributors. In accordance with guidance related to accounting for fees and consideration given by a vendor to a customer (including a resellerof a vendor's products), these fees, discounts and rebates are presumed to be a reduction of the selling price of Feraheme. Product sales allowances andaccruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and regulations) related to the purchase and/orutilization of the product by these entities. Allowances and accruals are generally recorded in the same period that the related revenue is recognized andare estimated using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates, contract performanceby the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of other similar products toFeraheme, specific known market events and trends such as competitive pricing and new product introductions and current and forecasted customerbuying patterns and inventory levels, including the shelf life of our products. As part of this evaluation, we also review changes to federal legislation,changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Reserve estimates are evaluated quarterly and mayrequire adjustments to better align our estimates with actual results. Although allowances and accruals are recorded at the time of product sale, certainrebates are typically paid out, on average, up to six months or longer after the sale. If actual future results vary from our estimates, we may need toadjust our previous estimates, which would affect our earnings in the period of the adjustment. Because we only recently launched Feraheme in the U.S. there are a number of factors that make it particularly difficult to predict the magnitude offuture Feraheme sales, including the magnitude and timing of adoption of Feraheme by physicians, dialysis clinics, hospitals and other healthcarepayors and providers, the inventory levels maintained by Feraheme wholesalers, distributors and other customers, the frequency of re-orders byexisting customers, and the pricing of products that compete with Feraheme and other actions taken by our competitors. Accordingly, our Feraheme netproduct revenues in previous quarters may not be indicative of future Feraheme net product revenues. As a result of these and other factors, futureFeraheme sales could vary significantly from quarter to quarter.Product Returns Consistent with industry practice, we generally offer our distributors and wholesaler customers a limited right to return product purchased directlyfrom us which is principally based upon the product's expiration date. We currently estimate product returns based upon historical trends in thepharmaceutical industry and trends for products similar to Feraheme sold by others. We track actual returns by individual production lots. Returns onlots eligible for credits under our returned goods policy are monitored and compared with historical return trends and rates.Deferred Revenue—Launch Incentive Program During the third quarter of 2009 certain dialysis organizations purchased Feraheme from us under our Launch Incentive Program. Thesepurchases were made under agreements which provided these customers with an opportunity to purchase Feraheme through September 30, 2009 atdiscounted pricing and further provided for extended payment terms and expanded rights of return. As a result, in accordance with current accountingguidance which requires that we defer recognition of revenues until we can reasonably estimate returns related to those shipments, we have deferred therecognition of revenues associated with these purchases until our customers report to us that such inventory has been utilized in their operations. Anypurchases returned to us will not be recorded as revenue. Accordingly,51Table of Contentsas of December 31, 2009, we recorded $10.2 million in deferred revenues, representing all product purchased under the Launch Incentive Programwhich remained held by the dialysis organizations at December 31, 2009, net of any applicable discounts and estimated rebates, which are included inour commercial rebate accruals as of December 31, 2009. In addition, we have deferred the related cost of product sales of approximately $0.3 millionand recorded such amount as finished goods inventory held by others as of December 31, 2009. We expect that utilization of the remaining deferredproduct revenues from the Launch Incentive Program, which were initially recorded during the third quarter of 2009, will increase going forward aseach Launch Incentive Program customer has begun to use Feraheme. However, with respect to inventory that remained held by others at December 31,2009, we are unable to reasonably estimate the amount of inventory that may be returned under this program, and therefore we cannot provide anyassurance that amounts reported as deferred revenue and associated with this program will be utilized by our customers and thereby recorded by us asproduct revenues in our future consolidated statements of operations.License Fee Revenues Our license fee revenues of $0.5 million and $1.0 million for the years ended December 31, 2009 and 2008, respectively, consisted of deferredlicense fee revenues that were being amortized in connection with our agreements with Bayer Healthcare Pharmaceuticals, or Bayer, which wereterminated in November 2008. In 1995, we entered into a License and Marketing Agreement and a Supply Agreement, or the Bayer Agreements, granting Bayer a product licenseand exclusive marketing rights to Feridex I.V. in the U.S. and Canada. In connection with our decision to cease manufacturing Feridex I.V., the BayerAgreements were terminated in November 2008 by mutual agreement. Prior to the termination of the Bayer Agreements, we accounted for the revenuesassociated with the Bayer Agreements on a straight line basis over their 15 year contract term. Pursuant to the termination agreement, Bayer continued tosell any remaining Feridex I.V. inventory in its possession through April 1, 2009. As a result of the termination of these agreements, during the yearended December 31, 2009 we recognized the remaining $0.5 million of deferred revenues under the Bayer Agreements. No further significantobligation exists by either party. In May 2008, we entered into a Collaboration and Exclusive License Agreement with 3SBio with respect to the development andcommercialization of Feraheme as an IV iron replacement therapeutic agent in China. In consideration of the grant of the license, we received an up-front payment of $1 million, the recognition of which has been deferred and is being recognized under the proportional performance methodology as wesupply Feraheme to 3SBio over the thirteen year initial term of the agreement. We do not expect license revenues under our agreement with 3SBio to besignificant in 2010.Costs and ExpensesCost of Product Sales We incurred costs of $1.0 million and $0.3 million associated with product sales, or 6% and 39% of net product sales, during the years endedDecember 31, 2009 and 2008, respectively. Our cost of product sales for the year ended December 31, 2009 was comprised primarily of manufacturingcosts associated with Feraheme. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval,certain of the costs of Feraheme sold during the year ended December 31, 2009 were expensed prior to the June 2009 FDA approval, and therefore arenot included in the cost of product sales during this period. We continue to hold Feraheme inventory that has been previously expensed, and once suchinventory has been fully depleted, we expect our cost of product sales as a percentage of net product sales will increase, reflecting the full manufacturingcost of our inventory. We cannot predict when such previously expensed materials will be exhausted, as this52Table of Contentswill be dependent on the timing and magnitude Feraheme sales in the U.S. We also anticipate that costs of product sales will increase as sales volumeincreases. In addition, as of December 31, 2009, we deferred approximately $0.3 million of costs associated with product sales made under our LaunchIncentive Program. These costs have been recorded as finished goods inventory held by others on our consolidated balance sheet as of December 31,2009. We will recognize the cost of product sold under the Launch Incentive Program as, and to the extent that, inventory is utilized by our customers.Research and Development Expenses Research and development expenses include external expenses, such as costs of clinical trials, contract research and development expenses, certainmanufacturing research and development costs, consulting and professional fees and expenses, and internal expenses, such as compensation ofemployees engaged in research and development activities, the manufacture of product needed to support research and development efforts, related costsof facilities, and other general costs related to research and development. To the extent that external costs are not attributable to a specific project oractivity, they are included in other external costs. Prior to the June 30, 2009 regulatory approval of Feraheme, costs associated with manufacturingprocess development and the manufacture of drug product were recorded as research and development expenses. Subsequent to FDA approval, costsassociated with the manufacture of Feraheme to be made commercially available in the U.S. are capitalized. Research and development expenses for the years ended December 31, 2009 and 2008 consisted of the following (in thousands): Total research and development expenses incurred in the year ended December 31, 2009 amounted to $36.3 million, an increase of $4.6 million, or14%, from the year ended December 31, 2008. The $4.6 million increase was primarily due to costs incurred in the first half of 2009 in connection withour efforts to address the manufacturing observations noted by the FDA during a 2008 inspection of our Cambridge, Massachusetts manufacturingfacility, costs associated with our regulatory plans outside of the U.S., costs associated with increased full-time equivalent headcount and increasedspending on our clinical development programs for PAD and IDA. The increase in total research and development expenses was partially offset bycosts associated with the manufacture of Feraheme, which were expensed in 2008 as research and development costs but, as a result of the June 2009FDA approval of Feraheme, were capitalized into inventory in the second half of 2009 and by a reduction in costs associated with our then intendedFeraheme clinical development program in patients with AUB.53 Years EndedDecember 31, 2009 2008 $ Change % Change External Research and Development Expenses Feraheme to treat IDA regardless of the underlying cause $797 $— $797 N/A Feraheme to treat IDA in CKD patients 346 — 346 N/A Feraheme as a therapeutic agent in AUB patients 1,131 2,383 (1,252) -53% Feraheme as a therapeutic agent, general 4,331 1,601 2,730 >100% Feraheme as an imaging agent in PAD patients 2,524 1,643 881 54% Feraheme manufacturing and materials 2,929 4,591 (1,662) -36% Other external costs 1,133 1,025 108 11% Total $13,191 $11,243 $1,948 17% Internal Research and Development Expenses Compensation, payroll taxes, benefits and other expenses 18,636 16,713 1,923 12% Equity-based compensation expense 4,446 3,760 686 18% Total $23,082 $20,473 $2,609 13% Total Research and Development Expenses $36,273 $31,716 $4,557 14% Table of Contents Our external research and development expenses increased by $1.9 million, or 17%, for the year ended December 31, 2009 as compared to theyear ended December 31, 2008. The increase in our external expenses was due primarily to costs incurred in the first half of 2009 in connection withour efforts to address the manufacturing observations noted by the FDA during a 2008 inspection of our Cambridge, Massachusetts manufacturingfacility. In addition, during 2009 we began preparations for our Phase III clinical development program for Feraheme to treat IDA regardless of theunderlying cause and progressed our Phase II study of Feraheme as a diagnostic agent for vascular-enhanced MRI for the assessment of PAD. Theseincreased external research and development expenses were partially offset by the capitalization to inventory of certain external Feraheme manufacturingand materials costs as well as reduced costs in 2009 related to the development of second source manufacturing. In addition, during 2008, we incurredcosts related to our then intended Ferahemeclinical development program in patients with AUB. However, during the first quarter of 2009 followingdiscussions with the FDA, we decided to pursue a broad Phase III clinical development program for the treatment of IDA in a wide range of patientpopulations and disease states rather than pursue individual indications, such as AUB. As a result, we did not begin enrollment in our previouslyplanned Phase III studies of Feraheme in women with AUB. Subsequent to the first quarter of 2009, we did not incur any costs associated with theAUB clinical development program and do not expect to incur any significant additional future costs associated with the AUB clinical developmentprogram. During 2009, we began to incur costs associated with our broader IDA clinical development program and plan to initiate our Phase IIIprogram in mid-2010. Our internal research and development expenses increased by $2.6 million, or 13%, for the year ended December 31, 2009 as compared to the yearended December 31, 2008. The increase in internal costs was due primarily to higher compensation and benefits costs as a result of additional researchand development personnel hired as we expanded our development infrastructure and scaled-up our manufacturing capabilities in preparation for theU.S. commercial launch of Feraheme, partially offset by the mid-year commencement of the capitalization to inventory of internal costs associated withthe manufacture of Feraheme, including certain manufacturing personnel-related compensation, payroll taxes, benefits and other expenses. AtDecember 31, 2009, we had 55 full-time equivalents, or FTEs, in research and development as compared to 86 FTEs at December 31, 2008, a decreaseof 36% due primarily to the reallocation of manufacturing personnel out of research and development following FDA approval of Feraheme in June2009. The $0.7 million increase in equity-based compensation expense was primarily attributable to increased equity awards to both new and existingemployees. We expect research and development expenses in 2010 to be significantly higher than our research and development expenses in 2009 primarily asa result of the advancement and the initiation of our clinical development programs and other research and development related functions and activities insupport of Feraheme. Factors which will impact 2010 research and development expenses include the timing of initiation and pace of enrollment of ourpediatric studies of Feraheme and our trial of Feraheme to support our MAA filing with the EMEA, and the design, timing and pace of enrollment ofour other clinical trials of Feraheme, including our planned development program for Feraheme in a broad range of patients with IDA. We do not track our internal costs by project since our research and development personnel work on a number of projects concurrently and muchof our fixed costs benefit multiple projects or our operations in general. We track our external costs on a major project by major project basis, in mostcases through the later of the completion of the last trial in the project or the last submission of a regulatory filing to the FDA or applicable foreignregulatory body. We currently anticipate commencing the following two major research and development projects during 2010:•Feraheme to treat IDA regardless of the underlying cause. This project currently includes a Phase III clinical study evaluating Ferahemetreatment compared to treatment with placebo, a54Table of Contentssecond Phase III clinical study evaluating Feraheme treatment compared to treatment with another IV iron, and an extension study.•Feraheme to treat IDA in CKD patients. This project includes: (1) a clinical study evaluating Feraheme treatment compared to treatmentwith another IV iron which will support our planned CKD MAA; (2) two pediatric studies to be conducted as part of our Phase IVPediatric Research Equity Act requirement to support pediatric CKD labeling of Feraheme; and (3) two additional pediatric studies inaccordance with our approved Pediatric Investigation Plan to support our planned CKD MAA. During the year ended December 31, 2009, we incurred aggregate external research and development expenses of approximately $0.8 millionrelated to our preparation for our research and development project for Feraheme to treat IDA regardless of the underlying cause. We currently estimatethat the external costs associated with the efforts needed to complete the development project of Feraheme to treat IDA regardless of the underlyingcause will be in the range of approximately $70 to $80 million over the next several years. During the year ended December 31, 2009, we incurred aggregate external research and development expenses of approximately $0.3 millionrelated to our preparation for our research and development project for Feraheme to treat IDA in CKD patients. We currently estimate that the externalcosts associated with the efforts needed to complete the development project of Feraheme to treat IDA in CKD patients will be in the range ofapproximately $30 to $40 million over the next several years. Conducting clinical trials involves a number of uncertainties, many of which are out of our control. Our estimates of external costs associated withour research and development projects could therefore vary from our current estimations for a variety of reasons including but not limited to thefollowing: significant delays in our clinical trials due to slow enrollment, unexpected results from our clinical sites that affect our ability to complete thestudies in a timely manner, inadequate performance or errors by third-party service providers, any deficiencies in the design or oversight of these studiesby us, the need to conduct additional clinical trials or a delay in the submission of any applicable regulatory filing.Selling, General and Administrative Expenses Our selling, general and administrative expenses include costs related to our commercial personnel, including our 80-person specialized sales force,medical education professionals, and other commercial support personnel, administrative personnel costs, external and facilities costs required tosupport the marketing and sale of Feraheme and other costs associated with our corporate-related activities. Selling, general and administrative expenses for the years ended December 31, 2009 and 2008 consisted of the following (in thousands): The $28.3 million, or 57%, increase in selling, general and administrative expenses for the year ended December 31, 2009 as compared to the yearended December 31, 2008 was due primarily to increased costs associated with the expansion of our commercial operations function and our generaladministrative infrastructure to support our growth as a commercial entity, including compensation and55 Years EndedDecember 31, 2009 2008 $ Change % Change Compensation, payroll taxes and benefits $33,447 $17,292 $16,155 93%Professional and consulting fees and other expenses 33,450 27,967 5,483 20%Equity-based compensation expense 10,932 4,277 6,655 >100% Total $77,829 $49,536 $28,293 57% Table of Contentsbenefits costs related to increased headcount and increased advertising and promotion costs associated with the July 2009 U.S. commercial launch ofFeraheme. At December 31, 2009, we had 178 employees in our selling, general and administrative departments as compared to 170 employees atDecember 31, 2008, a 5% increase. The $16.2 million increase in compensation and benefits costs reflected costs associated with a full scaleorganization in 2009 as compared to our 2008 compensation and benefits costs, which reflected significantly lower costs associated with, among otherthings, a lower average headcount. Of the $6.7 million increase in equity-based compensation expense, $4.3 million was due primarily to grants ofequity awards to both new and existing employees. In addition, during 2008 we reversed approximately $2.4 million of previously recorded expenseassociated with performance-based stock options granted to certain of our executive officers in 2007 in which the underlying performance conditionwas not met. We expect selling, general and administrative expenses to continue to increase in 2010 as we continue to expand our U.S. commercialization effortsrelated to Feraheme, execute our marketing and promotional programs, and maintain our commercial and administrative infrastructure to support thecommercialization of Feraheme.Other Income (Expense) Other income (expense) for the years ended December 31, 2009 and 2008 consisted of the following (in thousands): Other income (expense) for the year ended December 31, 2009 decreased by $4.4 million, or 57%, compared to the year ended December 31,2008. The $4.4 million decrease was primarily attributable to a $6.0 million decrease in interest and dividend income as the result of a lower averageamount of invested funds and lower interest rates in the year ended December 31, 2009 as compared to the year ended December 31, 2008, partiallyoffset by the recognition of $1.3 million in realized losses during 2008 that did not recur during 2009. In November 2008, we elected to participate in a rights offering by UBS AG, or UBS, one of our securities brokers, which provided us with theright to sell to UBS $9.3 million in par value of our auction rate securities, or ARS, at par value, at any time during a two-year sale period beginningJune 30, 2010, or the Settlement Rights. As a result of the lack of either quoted market prices or other observable market data, we estimate the value ofour ARS and Settlement Rights using discounted cash flow analyses using Level 3 inputs as defined by the accounting guidance related to fair valuemeasurements. We elected the fair value option with respect to the Settlement Rights in accordance with current accounting guidance related to the fairvalue option for financial assets and financial liabilities and as of December 31, 2009, we have recorded an asset equal to our estimated fair value of theSettlement Rights of approximately $0.8 million in our consolidated balance sheet. This represents a decrease of approximately $0.8 million to theestimated fair value of our Settlement Rights from the estimated fair value at December 31, 2008, which we have recorded in other income (expense) inour consolidated statement of operations. In addition, with the opportunity provided by the Settlement Rights, we have designated the ARS subject tothe Settlement Rights with a par value of $9.3 million and an estimated fair value of $8.5 million as of December 31, 2009 as trading securities.Accordingly,56 Years EndedDecember 31, 2009 2008 $ Change % Change Interest and dividend income, net $3,154 $9,139 $(5,985) -65%Gains (losses) on investments, net 942 (3,024) 3,966 <(100)%Fair value adjustment of settlement rights (778) 1,566 (2,344) <(100)% Total $3,318 $7,681 $(4,363) -57% Table of Contentsas of December 31, 2009, we have adjusted our estimated value of these trading securities by approximately $0.9 million from the estimated value atDecember 31, 2008, which we have recorded as a gain on investments in other income (expense) in our consolidated statement of operations. We are required to assess the fair value of both the Settlement Rights and our ARS subject to Settlement Rights and record changes each perioduntil the Settlement Rights are exercised or our ARS subject to Settlement Rights are redeemed. Although the Settlement Rights represent the right tosell the securities back to UBS at par, we are required to periodically assess the ability of UBS to meet that obligation in assessing the fair value of theSettlement Rights. We expect interest and dividend income to increase in 2010 as a result of our anticipated investment of cash received from our January 2010 sale of3,600,000 shares of our common stock at a public offering price of $48.25 per share and which resulted in net proceeds to us of approximately$165.6 million.Income Tax Benefit We recognized an income tax benefit of $1.3 million and $0.3 million during the years ended December 31, 2009 and 2008, respectively. During2009, we recognized a $1.1 million tax benefit, which was the result of our recognition of a corresponding $1.1 million income tax expense associatedwith the increase in the value of certain securities that we carried at fair market value during the year ended December 31, 2009. This income taxexpense was recorded in other comprehensive income. There were no similar income tax benefits or provisions for the year ended December 31, 2008.In addition, during 2009 and 2008, we recognized $0.2 million and $0.3 million in income tax benefit, respectively, associated with U.S. research anddevelopment tax credits against which we had previously provided a full valuation allowance, but which became refundable as a result of legislationpassed in each year.Net Loss For the reasons stated above, we incurred a net loss of $93.4 million, or $5.46 per basic and diluted share, for the year ended December 31, 2009as compared to a net loss of $71.6 million, or $4.22 per basic and diluted share, for the year ended December 31, 2008.Year Ended December 31, 2008 Compared to Year Ended December 31, 2007Revenues Total revenues were $1.9 million and $2.6 million for the years ended December 31, 2008 and 2007, respectively. The decrease in revenues wasprimarily the result of a decrease in product sales and license fee revenues, as discussed below. The following table sets forth customers who represented 10% or more of our revenues for the years ended December 31, 2008 and 2007. Noother company accounted for more than 10% of our total revenues in either year.57 Years Ended December 31, 2008 2007 Bayer 53% 43%Guerbet 24% 26%Covidien 17% 15%Cytogen — 14%Table of Contents Our revenues for the years ended December 31, 2008 and 2007 consisted of the following (in thousands):License Fee Revenues All of our license fee revenues for the year ended December 31, 2008 consisted of deferred license fee revenues that were being amortized inconnection with our agreements with Bayer, which were terminated in November 2008. Our license fee revenues for the year ended December 31, 2007included deferred license fee revenues that were being amortized in connection with our agreements with Bayer as well as with a License and MarketingAgreement signed with Cytogen Corporation, or Cytogen, which terminated in February 2007. In 1995, we entered into the Bayer Agreements granting Bayer a product license and exclusive marketing rights to Feridex I.V. in the U.S. andCanada. In connection with our decision to cease manufacturing Feridex I.V., the Bayer Agreements were terminated in November 2008 by mutualagreement. Prior to the termination of the Bayer Agreements, we accounted for the revenues associated with the Bayer Agreements on a straight linebasis over their 15 year contract term. Pursuant to the termination agreement, Bayer continued to sell any remaining Feridex I.V. inventory in itspossession through April 1, 2009, at which time we also completed the recognition of any remaining deferred revenues. In 2000, we entered into a License and Marketing Agreement with Cytogen in which, among other things, we granted Cytogen exclusive U.S.marketing rights to Combidex®, a molecular imaging agent which we are not actively pursuing development of in the U.S. At the time of signing thatagreement, we received shares of common stock of Cytogen with a market value of approximately $13.5 million as a non-refundable licensing fee. Thisfee was being recognized as revenue over the development period of the products subject to the License and Marketing Agreement based upon costsincurred and expected remaining expenditures related to the agreement. The entire amount of the license fee was recorded as deferred revenues uponsigning the License and Marketing Agreement. In February 2007, as part of the settlement of a lawsuit with Cytogen, we paid Cytogen $4.0 million incash. In addition, the License and Marketing Agreement was terminated and the remainder of the deferred revenues associated with this agreement,$0.4 million, was recognized in February 2007 as there were no additional performance obligations under the License and Marketing Agreement due toits termination.58 Years EndedDecember 31, 2008 2007 $ Change % Change Revenues: Product sales, net $751 $1,208 $(457) -38% License fees 959 1,096 (137) -13% Royalties 228 248 (20) -8% Total $1,938 $2,552 $(614) -24% Table of Contents Total license fee revenues for the years ended December 31, 2008 and 2007 were recognized as follows (in thousands):Product Sale Revenues Product sale revenues for the years ended December 31, 2008 and 2007 consisted of the following (in thousands): The $0.5 million decrease in product sale revenues during the year ended December 31, 2008 as compared to the year ended December 31, 2007primarily resulted from a decrease in sales of GastroMARK to our marketing partners and a decrease in sales of bulk Combidex to one of our foreignmarketing partners for research and development purposes. Product sales of GastroMARK may fluctuate from period to period. Fluctuations in ourGastroMARK product sales are primarily attributable to unpredictable annual product demand by end users and the batch sizes in which our productsare manufactured and shipped, which create uneven purchasing patterns by our marketing partners.Costs and ExpensesCost of Product Sales We incurred costs of $0.3 million associated with product sales during both of the years ended December 31, 2008 and 2007. These costsrepresented approximately 39% and 26% of product sales during the years ended December 31, 2008 and 2007, respectively. The increase in cost ofsales as a percentage of product sales during 2008 was partially due to the write-off of $0.2 million of inventory associated with our decision to ceasethe manufacture and commercialization of Feridex I.V. in November 2008. The cost of product sales and therefore our gross margins are dependent onthe mix of customers, prices we charge for our products, product mix, changes in unit volume and production efficiencies, none of which had a materialimpact during 2008 or 2007.59 Years EndedDecember 31, 2008 2007 $ Change % Change License fee revenues recognized in connection with the Cytogenagreement $— $358 $(358) -100%License fee revenues recognized in connection with the Bayer Agreements 959 738 221 30% Total $959 $1,096 $(137) -13% Years EndedDecember 31, 2008 2007 $ Change % Change GastroMARK $398 $705 $(307) -44%Feridex I.V. 333 368 (35) -10%Other 20 135 (115) -85% Total $751 $1,208 $(457) -38% Table of ContentsResearch and Development Expenses Research and development expenses include external expenses, such as costs of clinical trials, contract research and development expenses,commercial manufacturing preparation and related materials costs, consulting and professional fees and expenses, and internal expenses, such ascompensation of employees engaged in research and development activities, the manufacture of product needed to support research and developmentefforts, related costs of facilities, and other general costs related to research and development. To the extent that external costs are not attributable to aspecific major project or activity, they are included in other external costs. Manufacturing costs are expensed as incurred until a product has received thenecessary initial regulatory approval. Research and development expenses for the years ended December 31, 2008 and 2007 consisted of the following (in thousands): Total research and development expenses incurred in the year ended December 31, 2008 amounted to $31.7 million, an increase of $7.5 million, or31%, from the year ended December 31, 2007. The $7.5 million increase was primarily attributable to costs associated with increased headcount,increased production materials and supply costs, costs associated with our preparation for commercial scale manufacturing of Feraheme, costsassociated with the commencement of spending on our AUB and PAD clinical trials and increased equity-based compensation expense, partially offsetby a decrease in expenditures related to our December 2007 New Drug Application, or NDA, submission for Feraheme, which were not present duringthe year ended December 31, 2008. Our external research and development expenses decreased by $1.2 million, or 9%, for the year ended December 31, 2008 as compared to the yearended December 31, 2007. The decrease in our external expenses was due primarily to the decrease in expenditures associated with the developmentprogram and regulatory submission, including FDA filing fees of $1.2 million incurred during 2007 for Feraheme as an IV iron replacementtherapeutic agent in CKD patients as we completed our Phase III clinical trials and prepared for the submission of our NDA in 2007. These decreasedcosts were partially offset by increased costs associated with the commencement of spending on our then planned clinical trials of Feraheme for AUBand our clinical trial for PAD and an increase in materials procurement, second-source manufacturing qualification, and other costs associated with our60 Years EndedDecember 31, 2008 2007 $ Change % Change External Research and Development Expenses Feraheme as an IV iron replacement therapeutic agent in CKDpatients $1,601 $10,043 $(8,442) -84% Feraheme as an IV iron replacement therapeutic agent in AUBpatients 2,383 — 2,383 N/A Feraheme as an imaging agent in PAD patients 1,643 — 1,643 N/A Feraheme manufacturing and materials 4,591 — 4,591 N/A Other external costs 1,025 2,373 (1,348) -57% Total $11,243 $12,416 $(1,173) -9% Internal Research and Development Expenses Compensation, payroll taxes, benefits and other expenses 16,713 9,884 6,829 69% Equity-based compensation expense 3,760 1,936 1,824 94% Total $20,473 $11,820 $8,653 73% Total Research and Development Expenses $31,716 $24,236 $7,480 31% Table of Contentspreparation for commercial scale manufacturing of Feraheme as an IV iron replacement therapeutic agent in CKD patients. Our internal research and development expenses increased by $8.7 million, or 73%, for the year ended December 31, 2008 as compared to the yearended December 31, 2007. The increase in internal costs was due primarily to higher compensation and benefits costs as a result of hiring additionalresearch and development personnel as we continued to expand our development infrastructure and scaled-up our manufacturing capabilities for theplanned commercialization of Feraheme. At December 31, 2008, we had 86 employees in research and development as compared to 50 employees atDecember 31, 2007, an increase of 72%. The $1.8 million increase in equity-based compensation expense was primarily attributable to increased equityawards to both new and existing employees.Selling, General and Administrative Expenses Selling, general and administrative expenses for the years ended December 31, 2008 and 2007 consisted of the following (in thousands): The $29.1 million, or greater than 100%, increase in selling, general and administrative expenses for the year ended December 31, 2008 ascompared to the year ended December 31, 2007 was due primarily to increased costs associated with the expansion of our commercial operationsfunction, including compensation and benefits costs related to increased headcount, consulting costs related to preparing for the U.S. commercial launchof Feraheme, and the expansion of our general and administrative infrastructure. At December 31, 2008, we had 170 employees in our selling, generaland administrative departments as compared to 31 employees at December 31, 2007, a greater than four-fold increase. The $2.0 million decrease in equity-based compensation expense was primarily attributable to the reversal of expense associated with performance-based stock options granted to certain of our executive officers in 2007, the vesting of which was contingent upon FDA approval of Feraheme byDecember 31, 2008. Our NDA for Feraheme was not approved by the FDA at December 31, 2008 and as a result, the performance conditionsunderlying the 110,000 performance-based stock options issued in 2007 were not met. Accordingly, during 2008 we reversed approximately$2.4 million of compensation cost recorded during 2007 from selling, general and administrative expenses associated with these performance-basedgrants. This reversal of equity-based compensation expense was partially offset by additional 2008 expense associated with increased equity awards fornew and existing employees as well as $0.3 million in incremental expense related to market condition based equity awards granted to our ChiefExecutive Officer during the year ended December 31, 2008.61 Years EndedDecember 31, 2008 2007 $ Change % Change Compensation, payroll taxes and benefits $17,292 $4,914 $12,378 >100%Professional and consulting fees and other expenses 27,967 9,236 18,731 >100%Equity-based compensation expense 4,277 6,246 (1,969) -32% Total $49,536 $20,396 $29,140 >100% Table of ContentsOther Income (Expense) Other income (expense) for the years ended December 31, 2008 and 2007 consisted of the following (in thousands): The $0.8 million, or 10%, decrease in other income (expense) for the year ended December 31, 2008 as compared to the year ended December 31,2007 was primarily attributable to a $3.4 million decrease in interest and dividend income as the result of a lower average amount of invested funds andlower interest rates in the year ended December 31, 2008 as compared to the year ended December 31, 2007. In addition, we also recognized$3.0 million of net losses in connection with impairment charges related to certain securities held by us. Of the total $3.0 million impairment charge,$1.3 million was required in connection with the sale of certain securities and losses on securities whose decline in value we deemed to be other-than-temporarily impaired. The remaining $1.7 million was required as a result of the mark to market and resulting realization of losses on certain ARSredesignated as trading securities under current guidance related to accounting for investments in debt and equity securities. No such losses wererecognized in the year ended December 31, 2007. The decrease in other income (expense) was partially offset by our recognition of a $1.6 million gainassociated with the Settlement Rights we received from UBS during the year ended December 31, 2008. In addition, we recorded a $4.0 millionsettlement with Cytogen in the year ended December 31, 2007 that did not recur in 2008.Income Tax Benefit During the year ended December 31, 2008, we recognized a tax benefit of $0.3 million associated with U.S. research and development tax creditsagainst which we had previously provided a full valuation allowance, but which became refundable as a result of legislation passed in July 2008.Net Loss For the reasons stated above, we incurred a net loss of $71.6 million, or $4.22 per basic and diluted share, for the year ended December 31, 2008as compared to a net loss of $33.9 million, or $2.15 per basic and diluted share, for the year ended December 31, 2007.Liquidity and Capital ResourcesGeneral We finance our operations primarily from the sale of Feraheme, the sale of our common stock, cash generated from our investing activities, andpayments from our strategic partners. Our long-term capital requirements will depend on many factors, including, but not limited to, the following:•Our ability to successfully commercialize Feraheme in the U.S. as an IV iron replacement therapeutic agent; •The magnitude of Feraheme sales and the timing of the receipt of cash from such sales;62 Years EndedDecember 31, 2008 2007 $ Change % Change Interest and dividend income, net $9,139 $12,506 $(3,367) -27%Gains (losses) on investments, net (3,024) — (3,024) N/A Fair value adjustment of settlement rights 1,566 — 1,566 N/A Litigation settlement — (4,000) 4,000 -100% Total $7,681 $8,506 $(825) -10% Table of Contents•Costs associated with the U.S. commercialization of Feraheme, including costs associated with maintaining our commercialinfrastructure and executing our promotional and marketing strategy for Feraheme; •Costs associated with our development of additional indications for Feraheme in the U.S.; •Costs associated with our pursuit of approval for Feraheme as an IV iron replacement therapeutic agent outside of the U.S.; •Costs associated with commercial-scale manufacturing of Feraheme, including costs associated with maintaining commercial inventoryand qualifying additional manufacturing capacities and second source suppliers; •Costs associated with potential business development and in-licensing activities; •Our ability to liquidate our investments in ARS, in a timely manner and without significant loss; •The impact of the current volatility of the credit and capital markets upon the investments in our portfolio; •Our ability to establish additional development and marketing arrangements on favorable terms or to enter into alternative strategicrelationships, if necessary; and •Our ability to raise additional capital on terms and within a timeframe acceptable to us, if necessary. As of December 31, 2009, our investments consisted of corporate debt securities, U.S. treasury and government agency securities, and ARS. Weplace our cash and investments in instruments that meet high credit quality standards, as specified in our investment policy. Our investment policy alsolimits the amount of our credit exposure to any one issue or issuer and seeks to manage these assets to achieve our goals of preserving principal,maintaining adequate liquidity at all times, and maximizing returns. Cash and cash equivalents, which consist principally of cash held in commercial bank accounts, money market funds and U.S. Treasury Billshaving an original maturity of less than three months, and investments at December 31, 2009 and December 31, 2008 consisted of the following (inthousands): The decrease in cash and cash equivalents and investments as of December 31, 2009 as compared to December 31, 2008 is primarily the result ofcash used in operations partially offset by cash received from Feraheme sales, the net impact of unrealized and realized gains and losses on ourinvestments, and interest income. As of December 31, 2009, we believe that our cash, cash equivalents, and short-term investments, combined with the cash we received from ourJanuary 2010 public offering, the cash we currently expect to receive from sales of Feraheme and earnings on our investments, will be sufficient tosatisfy our future cash flow needs for at least the next twelve months, including projected operating expenses related to our ongoing development andcommercialization programs for Feraheme. At December 31, 2009, we held a total of $57.5 million in fair market value of ARS, reflecting an impairment of approximately $7.9 millioncompared to our cost basis of these securities of63 December 31, 2009 2008 $ Change % Change Cash and cash equivalents $50,126 $64,182 $(14,056) -22%Short-term investments 29,578 94,914 (65,336) -69%Long-term investments 49,013 54,335 (5,322) -10% Total cash, cash equivalents and investments $128,717 $213,431 $(84,714) -40% Table of Contents$65.4 million. Of the $7.9 million impairment, approximately $7.1 million was considered a temporary impairment and was reported as an unrealizedloss at December 31, 2009. The remaining $0.8 million represents a trading loss associated with our UBS ARS, which are described below andrecognized in our consolidated statements of operations. The substantial majority of our ARS portfolio was rated AAA as of December 31, 2009 by atleast one of the major securities rating agencies and were primarily collateralized by student loans substantially guaranteed by the U.S. governmentunder the Federal Family Education Loan Program. Prior to February 2008, these ARS typically reset through an auction process every 7 or 28 days,which generally allowed existing investors to either roll over their holdings and continue to own their securities or liquidate their holdings by sellingtheir securities at par value. In February 2008, our ARS began to experience failed auctions and have continued to experience failed auctions. In theevent that we need to access our investments in these securities, we will not be able to do so until a future auction is successful, the issuer calls thesecurity pursuant to a mandatory tender or redemption prior to maturity, a buyer is found outside the auction process, or the securities mature. For all ofour ARS, the underlying maturity date is in excess of one year and the majority have final maturity dates of 30 to 40 years in the future. We believe wewill ultimately be able to liquidate our investments without significant loss prior to the maturity dates noted above primarily due to the collateral securingmost of our ARS. However, it could take until final maturity of our ARS to realize the investments' par value. We are uncertain when the currentliquidity issues relating to ARS will improve, if at all, however, we do not anticipate that the current lack of liquidity with respect to our ARS willmaterially affect our ability to operate our business in the ordinary course over the next twelve months. In November 2008, we elected to participate in a rights offering by UBS, one of our brokers, which provided us with the right to sell to UBS$9.3 million in par value of our ARS portfolio, at par value at any time during a two-year sale period beginning June 30, 2010. By electing to participatein the rights offering, we granted UBS the right, exercisable at any time prior to June 30, 2010 or during the two-year sale period, to purchase or causethe sale of our ARS at par value, or the Call Right. UBS has stated that it will only exercise the Call Right for the purpose of restructurings, dispositionsor other solutions that will provide its clients with par value for their ARS. UBS has agreed to pay its clients the par value of their ARS within one dayof settlement of any Call Right transaction. Notwithstanding the Call Right, we are permitted to sell ARS to parties other than UBS, which wouldextinguish the Settlement Rights. Although the Settlement Rights represent the right to sell the securities back to UBS at par, we will be required toperiodically assess the economic ability of UBS to meet that obligation in assessing the fair value of the Settlement Rights. The ongoing distress in the global financial markets has had an adverse impact on financial market activities world-wide, resulting in, among otherthings, extreme volatility in security prices, severely diminished liquidity and credit availability, ratings downgrades of certain investments and decliningvaluations of others. Although we invest our excess cash in investment grade securities, there can be no assurance that changing circumstances will notaffect our future financial position, results of operations or liquidity.Year Ended December 31, 2009Cash flows from operating activities During the year ended December 31, 2009, our use of $90.7 million of cash in operations was due principally to our net loss of approximately$93.4 million adjusted for the following:•Additional costs of $9.1 million capitalized to inventory as of December 31, 2009; •An increase of $14.9 million in accounts receivable, excluding sales deferred under our Launch Incentive Program;64Table of Contents•An increase of $13.2 million in accounts payable and accrued expenses, including an increase of $5.7 million of reserves for commercialdiscounts and rebates; •Non-cash operating items of $16.6 million including equity-based compensation expense, depreciation and amortization, income taxbenefit, and other non-cash items; and •Changes in other operating assets and liabilities of ($3.1) million, which reflect timing differences between the receipt and payment ofcash associated with certain transactions and when such transactions are recognized in our results of operations. Our net loss for the year ended December 31, 2009 was primarily the result of pre- and post-approval commercialization costs, includingadvertising and promotion costs associated with our July 2009 U.S. launch of Feraheme, costs incurred to address the manufacturing observationsnoted by the FDA during the 2008 inspection of our manufacturing facility, compensation and other expenses associated with additional employeeshired for research and development and commercial operating activities, and general and administrative costs, partially offset by revenues ofapproximately $17.2 million and interest income of $3.2 million. We anticipate our net cash used in operating activities will decrease in 2010 from 2009 as a result of the cash we expect to receive from Ferahemesales partially offset by increased costs associated with the development of new indications and geographies for Feraheme and costs related to the U.S.commercialization of Feraheme.Cash flows from investing activities Cash provided by investing activities was $71.5 million in 2009 and was primarily attributable to net proceeds from sales and maturities of ourinvestments. We anticipate cash flows used in investing activities will increase in 2010 as compared to 2009, primarily as the result of our anticipated investmentof the cash we received from our January 2010 sale of 3,600,000 shares of our common stock at a public offering price of $48.25 per share and whichresulted in net proceeds to us of approximately $165.6 million.Cash flows from financing activities Cash provided by financing activities was $5.2 million in 2009 and was primarily attributable to the proceeds from the exercise of stock options aswell as proceeds from the issuance of common stock under our Employee Stock Purchase Plan. We expect our cash flows from financing activities willincrease in 2010 primarily as the result of our anticipated investment of the cash we received from our January 2010 public offering, as discussedabove.Year Ended December 31, 2008Cash flows from operating activities During the year ended December 31, 2008, our use of cash in operations of $52.3 million was due principally to our net loss of approximately$71.6 million, partially offset by the impact of $7.8 million of changes in certain assets and liabilities, approximately $10.0 million in equity-basedcompensation and other non-cash expenses, and $1.5 million of net losses on investments and Settlement Rights. Our net loss included compensation-related expenses associated with the hiring of additional employees for research and development and commercial operating activities, payments foractivities in support of the commercialization of Feraheme as an IV iron replacement therapeutic agent, and costs associated with clinical trials inindications other than CKD.65Table of ContentsCash flows from investing activities Cash used in investing activities was $87.2 million in 2008 and was primarily attributable to net proceeds from sales and maturities of ourinvestments.Cash flows from financing activities Cash provided by financing activities was $1.2 million in 2008 and was primarily attributable to the proceeds from the exercise of stock options.Contractual Obligations We currently have no long-term debt obligations, capital lease obligations, long-term purchase obligations or other long-term liabilities. Futurelease obligations and purchase commitments, as of December 31, 2009, are summarized in the chart below (in thousands).Operating and Facility Lease Obligations We have entered into certain operating leases, including leases of certain automobiles and certain laboratory and office equipment which expirethrough 2011. We lease approximately 110 automobiles for our field-based employees. This lease requires an initial minimum lease term of 12 monthsper automobile. We expect our monthly expense related to this operating lease to be approximately $60,000, which is included above. We areresponsible for certain disposal costs in the event of termination of the lease. In May 2008, we entered into a lease agreement for certain real property located at 100 Hayden Avenue, Lexington, Massachusetts for use as ourprincipal executive offices. The term of the lease began on May 22, 2008 and will continue until August 31, 2016 with two successive five yearextension terms at our option. The aggregate size of rentable floor area for the offices is 55,924 square feet, and the rent for the initial term commencedin February 2009. The lease requires us to pay rent as follows (in thousands):66 Payment due by period Total Less than1 year 1-3 years 3-5 years More than5 years Operating lease obligations, excluding facility lease $197 $125 $70 $2 $— Facility lease obligations 14,059 1,985 4,077 4,259 3,738 Purchase commitments 2,425 2,425 — — — Total $16,681 $4,535 $4,147 $4,261 $3,738 Period Minimum LeasePayments Year Ended December 31, 2010 $1,903 Year Ended December 31, 2011 1,959 Year Ended December 31, 2012 2,015 Year Ended December 31, 2013 2,071 Year Ended December 31, 2014 2,127 Thereafter 3,738 Total $13,813 Table of Contents During any extension term, the base rent will be an amount agreed upon by us and the landlord. In addition to base rent, we are also required topay a proportionate share of the landlord's annual operating costs.Purchase Commitments During 2009 we entered into various agreements with third-parties for which we had remaining purchase commitments of approximately$2.4 million as of December 31, 2009. These agreements principally related to certain outsourced commercial activities such as our field nursing staff,our information technology infrastructure, and other operational activities.Severance Arrangements We have entered into employment agreements with each of our executive officers, which provide for payments to such executives in the event thatthe executive is terminated other than for cause, as defined in the applicable employment agreement.Indemnification Agreements In the course of operating our business, we have entered into a number of indemnification arrangements under which we may be required to makepayments to or on behalf of certain third parties including our directors, officers and certain employees. For further discussion of how this may affectour business, refer to Note M of the Notes to Financial Statements included in Part II, Item 8 "Financial Statements and Supplementary Data" of thisAnnual Report on Form 10-K.Off-Balance Sheet Arrangements As of December 31, 2009, we did not have any off-balance sheet arrangements as defined in Regulation S-K, Item 303(a)(4)(ii).Critical Accounting Policies The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requiresmanagement to make certain estimates and assumptions that affect the reported amount of assets, liabilities, revenues and expenses, and the relateddisclosure of contingent assets and liabilities. The most significant estimates and assumptions are used in, but are not limited to, revenue recognition andrelated sales allowances, assessing investments for potential other-than-temporary impairment and determining values of investments, reserves fordoubtful accounts, accrued expenses, income taxes and equity-based compensation expense. Actual results could differ materially from those estimates.In making these estimates and assumptions, management employs critical accounting policies. Our critical accounting policies include revenuerecognition and related sales allowances, valuation of investments and equity-based compensation. Revenue recognition and related sales allowances. We recognize net product sales in accordance with current accounting guidance related to therecognition, presentation and disclosure of revenue in financial statements, which outlines the basic criteria that must be met to recognize revenue andprovides guidance for disclosure of revenue in financial statements. We recognize revenue when:•persuasive evidence of an arrangement exists; •delivery of product has occurred or services have been rendered; •the sales price charged is fixed or determinable; and •collection is reasonably assured.67Table of Contents We record product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and other rebates, distributor,wholesaler and GPO fees, and product returns as a reduction of revenue in our consolidated statement of operations at the time product sales arerecorded. Calculating these gross-to-net sales adjustments involves estimates and judgments based primarily on actual Feraheme sales data andforecasted customer buying patterns blended with historical experience of products similar to Feraheme sold by others. In addition, we also monitor ourdistribution channel to determine whether additional allowances or accruals are required based on inventory in our sales channel. Product sales allowances and accruals are comprised of both direct and indirect fees, discounts and rebates. Direct fees, discounts and rebates arecontractual 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 dialysisorganizations, physicians, clinics, hospitals, and GPOs that typically do not purchase products directly from us but rather from wholesalers andspecialty distributors. In accordance with guidance related to accounting for fees and consideration given by a vendor to a customer (including a resellerof a vendor's products), these fees, discounts and rebates are presumed to be a reduction of the selling price of Feraheme. Product sales allowances andaccruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and regulations) related to the purchase and/orutilization of the product by these entities. Allowances and accruals are generally recorded in the same period that the related revenue is recognized andare estimated using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates, contract performanceby the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of other similar products toFeraheme, specific known market events and trends such as competitive pricing and new product introductions and current and forecasted customerbuying patterns and inventory levels, including the shelf life of our products. As part of this evaluation, we also review changes to federal legislation,changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Reserve estimates are evaluated quarterly and mayrequire adjustments to better align our estimates with actual results. Although allowances and accruals are recorded at the time of product sale, certainrebates are typically paid out, on average, up to six months or longer after the sale. If actual future results vary from our estimates, we may need toadjust our previous estimates, which would affect our earnings in the period of the adjustment.Classification of Product Sales Allowance and Accruals Allowances against receivable balances primarily relate to prompt payment discounts, provider chargebacks and certain government agencychargebacks and are recorded at the time of sale, resulting in a reduction in product sales revenue or deferred revenue and the reporting of product salesreceivables net of allowances. Accruals related to Medicaid and provider volume rebates, wholesaler and distributor fees, GPO fees, other discounts tohealthcare providers and product returns are recorded at the time of sale, resulting in a reduction in product sales revenue and the recording of anincrease in accrued expenses.Discounts We typically offer a 2% prompt payment discount to our customers as an incentive to remit payment in accordance with the stated terms of theinvoice. Because we anticipate that those customers who are offered this discount will take advantage of the discount, we accrue 100% of the promptpayment discount, based on the gross amount of each invoice, at the time of sale. We adjust the accrual quarterly to reflect actual experience.68Table of ContentsChargebacks Chargeback reserves represent our estimated obligations resulting from the difference between the prices at which we sell Feraheme to wholesalersand the sales price ultimately paid to wholesalers under fixed price contracts by third-party payors, including governmental agencies. We determine ourchargeback estimates based on actual Feraheme sales data and forecasted customer buying patterns blended with historical experience of productssimilar to Feraheme sold by others, supplemented with other market research data related to demand patterns for iron replacement therapies which havebeen marketed for the past several years. Actual chargeback amounts are determined at the time of resale to the qualified healthcare provider, and wegenerally issue credits for such amounts within several weeks of receiving notification from the wholesaler. Estimated chargeback amounts are recordedat the time of sale, and we adjust the accrual quarterly to reflect actual experience.Governmental and Other Rebates Governmental and other rebate reserves relate to our reimbursement arrangements with state Medicaid programs or performance rebate agreementswith certain classes of trade. We determine our estimates for Medicaid rebates based on market research data related to utilization rates by various end-users and actual Feraheme sales data and forecasted customer buying patterns blended with historical experience of products similar to Feraheme soldby others. In estimating these reserves, we provide for a Medicaid rebate associated with both those expected instances where Medicaid will act as theprimary insurer as well as in those instances where we expect Medicaid will act as the secondary insurer. For rebates associated with reaching definedperformance goals, we determine our estimates using actual Feraheme sales data and forecasted customer buying patterns blended with historicalexperience of products similar to Feraheme sold by others. Rebate amounts generally are invoiced quarterly and paid in arrears, and we expect to paysuch amounts within several weeks of notification by the Medicaid or provider entity. We adjust the accrual quarterly to reflect actual experience.Distributor/Wholesaler and Group Purchasing Organization Fees Fees under our arrangements with distributors and wholesalers are usually based upon units of Feraheme purchased during the prior month orquarter and are usually paid by us within several weeks of our receipt of an invoice from the wholesaler or distributor, as the case may be. Fees underour arrangements with certain GPOs are usually based upon member purchases during the prior quarter and are generally billed by the GPO within30 days after period end. Current accounting standards related to consideration given by a vendor to a customer, including a reseller of a vendor'sproducts, specify that cash consideration given by a vendor to a customer is presumed to be a reduction of the selling price of the vendor's products orservices and therefore should be characterized as a reduction of revenue. Consideration should be characterized as a cost incurred if we receive, or willreceive, an identifiable benefit (goods or services) in exchange for the consideration and we can reasonably estimate the fair value of the benefitreceived. Because the fees we pay to wholesalers do not meet the foregoing conditions to be characterized as a cost, we have characterized these fees asa reduction of revenue. We generally pay such amounts within several weeks of our receipt of an invoice from the distributor, wholesaler, or GPO.Accordingly, we accrue 100% of the fee due, based on the gross amount of each invoice to the customer, at the time of sale. We adjust the accrualquarterly to reflect actual experience.Product Returns Consistent with industry practice, we generally offer our distributors and wholesaler customers a limited right to return product purchased directlyfrom us which is principally based upon the product's expiration date. We currently estimate product returns based upon historical trends in thepharmaceutical industry and trends for products similar to Feraheme sold by others. We track actual69Table of Contentsreturns by individual production lots. Returns on lots eligible for credits under our returned goods policy are monitored and compared with historicalreturn trends and rates. In addition to the factors discussed above, we consider several additional factors in our estimation process, including our internal sales forecastsand inventory levels in the distribution channel. We expect that wholesalers will not stock significant inventory due to the product's cost and expense tostore. When considering the level of inventory in the distribution channel, we determine whether an adjustment to the sales return reserve is appropriate.For example, if levels of inventory in the distribution channel increase and we believe sales returns will be larger than expected, we would adjust thesales return reserve, taking into account historical experience, our returned goods policy and the shelf life of our product, which, once packaged, iscurrently 24 months. If necessary, our estimated rate of returns may be adjusted for historical return patterns as they become available and for known or expectedchanges in the marketplace. To date, returns and adjustments to our estimated rate of returns have been minimal. If we were to reduce our productreturns estimate in the future, doing so would result in increased product sales at the time the return estimate is reduced. If circumstances change orconditions become more competitive in the iron replacement therapy market, we may increase our product returns estimate, which would result in anincremental reduction of product sales at the time the returns estimate is changed. For example, a 1.0% increase in our returns as a percentage of grosssales for the year ended December 31, 2009 would have resulted in approximately a $0.2 million decrease in net product sales. Valuation of investments. The fair value of our investments is generally determined from quoted market prices received from pricing servicesbased upon market transactions. We also have investments in ARS, which consist entirely of municipal debt securities backed by student loans andwhich, prior to 2008, we recorded at cost, which approximated fair market value due to their variable interest rates. Prior to February 2008, these ARStypically reset through an auction process every 7 or 28 days, which generally allowed existing investors to either roll over their holdings and continueto own their securities or liquidate their holdings by selling their securities at par value. In February 2008, our ARS began to experience failed auctionsand have continued to experience failed auctions. As a result, we no longer had evidence that the par value of these investments approximated their fairvalue and were required to seek other alternatives to determine the fair value of these securities, which are not based on observable market transactions.As a result, we began estimating the fair values of these securities utilizing a discounted cash flow analysis as opposed to valuing them at par value. Ourvaluation analysis considers, among other items, assumptions that market participants would use in their estimates of fair value, such as the collateralunderlying the security, the creditworthiness of the issuer and any associated guarantees, credit ratings of the security by the major securities ratingagencies, the ability or inability to sell the investment in an active market, the timing of expected future cash flows, and the expectation of the next timethe security may have a successful auction or when call features may be exercised by the issuer. We believe there are several significant assumptionsthat are utilized in our valuation analysis, the two most critical of which are the discount rate and the average expected term. In November 2008, weelected to participate in a rights offering by UBS, one of our brokers, which provided us with the right to sell to UBS $9.3 million in par value of ourARS portfolio, at par value, at any time during a two-year sale period beginning June 30, 2010, or the Settlement Rights. We estimate the fair value ofthese Settlement Rights utilizing a discounted cash flow analysis. Certain key assumptions used in this valuation are the estimated value of these rightsat the future date of settlement, the expected term until that date of settlement, and the risk that UBS will not be able to perform under the agreement. Holding all other factors constant, if we were to increase the discount rate utilized in our valuation analysis by 50 basis points, or one-half of apercentage point, this change would have had the effect of reducing the fair value of our entire ARS portfolio by approximately $1.2 million as ofDecember 31, 2009. Similarly, holding all other factors constant, if we were to increase the average expected term70Table of Contentsutilized in our fair value calculation by one year, this change would have had the effect of reducing the fair value of our ARS by approximately$1.5 million as of December 31, 2009. We also consider credit ratings with respect to our investments provided by investment ratings agencies. As ofDecember 31, 2009, all of our investments conformed to the requirements of our investment policy, which requires that, when purchased, all of ourinvestments meet high credit quality standards as defined by credit ratings of the major investment ratings agencies. These ratings are subject to change. In order to assess whether our investments in debt securities which experience a decline in fair value below amortized cost basis are other-than-temporarily impaired, we evaluate whether (i) we have the intent to sell the security or (ii) it is more likely than not that we will be required to sell thesecurity prior to recovery of its amortized cost basis. If either of these conditions is met, we recognize the difference between the amortized cost of thesecurity and its fair value at the impairment measurement date in our consolidated statement of operations. If neither of these conditions is met, we mustperform additional analyses to evaluate whether there could be a credit loss associated with the security. Factors we consider in making this judgmentinclude, but are not limited to:•the extent to which market value is less than the cost basis; •the length of time that the market value has been less than the cost basis; •whether the unrealized loss is event-driven, credit-driven or a result of changes in market interest rates or risk premium; •the investment's rating and whether the investment is investment-grade and/or has been downgraded since its purchase; •whether the issuer is current on all payments in accordance with the contractual terms of the investment and is expected to meet all of itsobligations under the terms of the investment; •any underlying collateral and the extent to which the recoverability of the carrying value of our investment may be affected by changes insuch collateral; •unfavorable changes in expected cash flows; and •other subjective factors. If we determine from this analysis that we do not expect to receive cash flows sufficient to recover the entire amortized cost of the security, a creditloss exists, and the impairment is considered other-than-temporary and recognized in our consolidated statement of operations. Our assessment ofwhether unrealized losses are other-than-temporary requires significant judgment. Equity-Based Compensation. Under the fair value recognition guidance of equity-based compensation accounting rules, equity-basedcompensation cost is generally required to be measured at the grant date (based upon an estimate of the fair value of the compensation granted) andrecorded to expense over the requisite service period, which generally is the vesting period. Because equity-based compensation expense is based onawards ultimately expected to vest, we must make certain judgments about whether employees and directors will complete the requisite service period.Accordingly, we have reduced the compensation expense being recognized for estimated forfeitures. Under the current accounting guidance, forfeituresare estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures areestimated based upon historical experience. If factors change and we employ different assumptions in future periods, the compensation expense that werecord in the future may differ significantly from what we have recorded in the current period. We estimate the fair value of equity-based compensation involving stock options based on the Black-Scholes option pricing model. We estimate thefair value of our restricted stock units whose vesting is contingent upon market conditions using the Monte-Carlo simulation model. These models71Table of Contentsrequire the input of several factors such as the expected option term, the expected risk-free interest rate over the expected option term, the expectedvolatility of our stock price over the expected option term, and the expected dividend yield over the expected option term and are subject to variousassumptions. The fair value of awards whose fair values are calculated using the Black-Scholes option pricing model are generally being amortized on astraight line basis over the requisite service period and is recognized based on the proportionate amount of the requisite service period that has beenrendered during each reporting period. The fair value of awards with market conditions are being amortized based upon the estimated derived serviceperiod. We believe our valuation methodologies are appropriate for estimating the fair value of equity awards we grant to employees and directors. Ourequity award valuations are estimates and thus may not be reflective of actual future results or amounts ultimately realized by recipients of these grants.These amounts, and the amounts applicable to future quarters, are also subject to future quarterly adjustments based upon a variety of factors, whichinclude, but are not limited to, changes in estimated forfeiture rates and the issuance of new equity-based awards. The fair value of restricted stock unitsgranted to employees and directors is determined based upon the quoted closing market price per share on the date of grant, adjusted for assumedforfeitures. As with any accounting policy that applies judgments and estimates, actual results could significantly differ from those estimates whichcould result in a material and/or adverse impact to our financial results.Impact of Recently Issued and Proposed Accounting Pronouncements In January 2010, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2010-6, ImprovingDisclosures About Fair Value Measurements, or ASU 2010-6, which also amends Accounting Standards Codification, or ASC 820. ASU 2010-6requires additional disclosure related to transfers in and out of Levels 1 and 2 and the activity in Level 3. This guidance requires a reporting entity todisclose separately the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and describe the reasons for thetransfers. In addition, this guidance requires a reporting entity to present separately information about purchases, sales issuances, and settlements in thereconciliation for fair value measurements using significant unobservable inputs (Level 3). This accounting standard is effective for interim and annualreporting periods beginning after December 31, 2009 other than for disclosures about purchases, sales, issuances and settlements in the roll forward ofactivity in Level 3 fair value measurements. Those disclosures will be effective for fiscal years beginning after December 31, 2010 and for interimperiods within those fiscal years. We are currently evaluating the potential impact of this standard on our consolidated financial statements. In October 2009, the FASB issued ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, or ASU 2009-13. ASU 2009-13 amendsexisting revenue recognition accounting pronouncements that are currently within the scope of FASB ASC Subtopic 605-25 (previously includedwithin Emerging Issues Task Force, or EITF, No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21). The consensus to EITFIssue No. 08-1, Revenue Arrangements with Multiple Deliverables, or EITF 08-1, provides accounting principles and application guidance on whethermultiple deliverables exist, how the arrangement should be separated, and the consideration allocated. This guidance eliminates the requirement toestablish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management's estimate ofthe selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. EITF 00-21 previouslyrequired that the fair value of the undelivered item be the price of the item either sold in a separate transaction between unrelated third parties or the pricecharged for each item when the item is sold separately by the vendor. This was difficult to determine when the product was not individually soldbecause of its unique features. Under EITF 00-21, if the fair value of all of the elements in the arrangement was not determinable, then revenue wasdeferred until all of the items were delivered or fair value was determined. This new approach is effective72Table of Contentsprospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. We are currentlyevaluating the potential impact of this standard on our consolidated financial statements. In December 2009, the FASB issued ASU No. 2009-16, Accounting for Transfers of Financial Assets, or ASU 2009-16. ASU 2009-16 relates tothe accounting and disclosure requirements related to the servicing and transfer of financial assets. ASU 2009-16 enhances information reported tousers of financial statements by providing greater transparency about transfers of financial assets and an entity's continuing involvement in transferredfinancial assets, including securitization transactions, where entities have continuing exposure to the risks related to transferred financial assets. Iteliminates the concept of a "qualifying special-purpose entity," changes the requirements for de-recognizing financial assets, and requires additionaldisclosures. This amendment is effective for fiscal years beginning after November 15, 2009. We do not expect the adoption of this amendment to havea significant impact on our consolidated financial statements. In December 2009, the FASB issued ASU No. 2009-17, Improvements to Financial Reporting by Enterprises Involved with Variable InterestEntities, or ASU 2009-17. ASU 2009-17 relates to the accounting and disclosure requirements related to the consolidation of variable interest entitiesand changes how a reporting entity determines when an entity that is insufficiently capitalized or is not controlled through voting (or similar rights)should be consolidated. The determination of whether a reporting entity is required to consolidate another entity is based on, among other things, theother entity's purpose and design and the reporting entity's ability to direct the activities of the other entity that most significantly impact the other entity'seconomic performance. The reporting entity will be required to provide additional disclosures about its involvement and will be required to disclose howits involvement with a variable interest entity affects the reporting entity's financial statements. This amendment is effective for fiscal years beginningafter November 15, 2009. Early application is not permitted. We do not expect the adoption of this amendment to have a significant impact on ourconsolidated financial statements.ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK: As of December 31, 2009, our short- and long-term investments totaled $78.6 million and were invested in corporate debt securities, U.S. treasuryand government agency securities, and ARS. These investments are subject to interest rate risk and will fall in value if market interest rates increase.However, even if market interest rates for comparable investments were to increase immediately and uniformly by 50 basis points, or one-half of apercentage point, from levels at December 31, 2009 and 2008, this would have resulted in a hypothetical decline in fair value of our investments,excluding ARS, which are described below, of approximately $0.1 million and $0.4 million, respectively. At December 31, 2009, we held a total of $57.5 million in fair market value of ARS, reflecting an impairment of approximately $7.9 millioncompared to the par value of these securities of $65.4 million. For further discussion on the analysis of the sensitivity of assumptions utilized in thevaluation of our ARS, refer to our critical accounting policy on the valuation of investments included in Part II, Item 7 "Management's Discussion andAnalysis of Financial Condition and Results of Operations" of this Annual Report on Form 10-K.73Table of ContentsITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA: Our Consolidated Financial Statements, Report of Management, and related Report of Independent Registered Public Accounting Firm arepresented in the following pages. The reports and financial statements included in this Part II, Item 8 are as follows: Management's Annual Report on Internal Control over Financial ReportingReport of Independent Registered Public Accounting FirmFinancial Statements:Consolidated Balance Sheets—as of December 31, 2009 and 2008Consolidated Statements of Operations—for the years ended December 31, 2009, 2008 and 2007Consolidated Statements of Comprehensive Loss—for the years ended December 31, 2009, 2008 and 2007Consolidated Statements of Stockholders' Equity—for the years ended December 31, 2009, 2008 and 2007Consolidated Statements of Cash Flows—for the years ended December 31, 2009, 2008 and 2007Notes to Consolidated Financial Statements74Table of ContentsINDEX TO CONSOLIDATED FINANCIAL STATEMENTS75Management's Annual Report on Internal Control over Financial Reporting 76Report of Independent Registered Public Accounting Firm 77Consolidated Balance Sheets—as of December 31, 2009 and 2008 78Consolidated Statements of Operations—for the years ended December 31, 2009, 2008 and 2007 79Consolidated Statements of Comprehensive Loss—for the years ended December 31, 2009, 2008 and 2007 80Consolidated Statements of Stockholders' Equity—for the years ended December 31, 2009, 2008 and 2007 81Consolidated Statements of Cash Flows—for the years ended December 31, 2009, 2008 and 2007 82Notes to Consolidated Financial Statements 83Table of ContentsMANAGEMENT'S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING Management is responsible for establishing and maintaining adequate internal controls over financial reporting, as such term is defined inRule 13a-15(f) under the Securities and Exchange Act of 1934, as amended, or the Exchange Act. All internal controls over financial reporting, nomatter how well designed, have inherent limitations. As a result of these inherent limitations, internal control over financial reporting may not prevent ordetect misstatements. Therefore, even those internal controls determined to be effective can provide only reasonable assurance with respect to reliabilityof financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, weconducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—IntegratedFramework issued by the Committee of Sponsoring Organizations of the Treadway Commission, together with related pronouncements issued by boththe Public Company Accounting Oversight Board and the U.S. Securities and Exchange Commission. Based on our evaluation under the framework inInternal Control—Integrated Framework, management concluded our internal control over financial reporting was effective as of December 31, 2009. Our internal control over financial reporting as of December 31, 2009 has been audited by PricewaterhouseCoopers LLP, an independentregistered public accounting firm, as stated in their report, which is included herein, which expresses an unqualified opinion on the effectiveness of ourinternal control over financial reporting as of December 31, 2009.76Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of AMAG Pharmaceuticals, Inc.: In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations, comprehensive loss,stockholders' equity, and cash flows present fairly, in all material respects, the financial position of AMAG Pharmaceuticals, Inc. and its subsidiaries atDecember 31, 2009 and 2008, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2009in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in allmaterial respects, effective internal control over financial reporting as of December 31, 2009, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company's managementis responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the effectivenessof internal control over financial reporting, included in the accompanying Management's Annual Report on Internal Control over Financial Reporting.Our responsibility is to express opinions on these financial statements and on the Company's internal control over financial reporting based on ourintegrated audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Thosestandards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of materialmisstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statementsincluded examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principlesused and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control overfinancial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists,and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performingsuch other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions. A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financialreporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company'sinternal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail,accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions arerecorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts andexpenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) providereasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have amaterial effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of anyevaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that thedegree of compliance with the policies or procedures may deteriorate./s/ PricewaterhouseCoopers LLPBoston, MassachusettsFebruary 26, 201077Table of ContentsAMAG Pharmaceuticals, Inc. Consolidated Balance Sheets (in thousands, except share and per share data) The accompanying notes are an integral part of these consolidated financial statements.78 As of December 31, 2009 2008 ASSETS Current assets: Cash and cash equivalents $50,126 $64,182 Short-term investments 29,578 94,914 Settlement rights 788 — Accounts receivable, net 27,350 408 Inventories 9,415 96 Prepaid and other current assets 5,472 4,710 Total current assets 122,729 164,310 Property, plant and equipment, net 12,417 11,223 Settlement rights — 1,566 Long-term investments 49,013 54,335 Restricted cash 460 521 Total assets $184,619 $231,955 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $5,432 $2,305 Accrued expenses 21,931 11,571 Deferred revenues 10,198 516 Total current liabilities 37,561 14,392 Long-term liabilities: Deferred revenues 1,000 1,000 Other long-term liabilities 3,081 3,149 Total liabilities 41,642 18,541 Commitments and contingencies (Notes M & N) Stockholders' equity: Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued — — Common stock, par value $0.01 per share, 58,750,000 shares authorized; 17,362,710 and17,018,159 shares issued and outstanding at December 31, 2009 and December 31,2008, respectively 174 170 Additional paid-in capital 432,414 411,538 Accumulated other comprehensive loss (7,925) (9,959)Accumulated deficit (281,686) (188,335) Total stockholders' equity 142,977 213,414 Total liabilities and stockholders' equity $184,619 $231,955 Table of ContentsAMAG Pharmaceuticals, Inc. Consolidated Statements of Operations (in thousands, except per share data) The accompanying notes are an integral part of these consolidated financial statements.79 Years Ended December 31, 2009 2008 2007 Revenues: Product sales, net $16,482 $751 $1,208 License fees 516 959 1,096 Royalties 180 228 248 Total revenues 17,178 1,938 2,552 Costs and expenses: Cost of product sales 1,013 292 320 Research and development expenses 36,273 31,716 24,236 Selling, general and administrative expenses 77,829 49,536 20,396 Total costs and expenses 115,115 81,544 44,952 Other income (expense): Interest and dividend income, net 3,154 9,139 12,506 Gains (losses) on investments, net 942 (3,024) — Fair value adjustment of settlement rights (778) 1,566 — Litigation Settlement — — (4,000) Total other income (expense) 3,318 7,681 8,506 Net loss before income taxes (94,619) (71,925) (33,894)Income tax benefit 1,268 278 — Net loss $(93,351)$(71,647)$(33,894) Net loss per share: Basic and diluted $(5.46)$(4.22)$(2.15)Weighted average shares outstanding used to compute net loss per share: Basic and diluted 17,109 16,993 15,777 Table of ContentsAMAG Pharmaceuticals, Inc. Consolidated Statements of Comprehensive Loss (in thousands) The accompanying notes are an integral part of these consolidated financial statements.80 Years Ended December 31, 2009 2008 2007 Net loss $(93,351)$(71,647)$(33,894) Other comprehensive income (loss): Unrealized gains (losses) on securities: Holding gains (losses) arising during period, net of tax 2,029 (13,110) 127 Reclassification adjustment for losses and gains, net, included in net loss 5 3,024 — Net unrealized gains (losses) 2,034 (10,086) 127 Total comprehensive loss $(91,317)$(81,733)$(33,767) Table of ContentsAMAG Pharmaceuticals, Inc. Consolidated Statements of Stockholders' Equity (in thousands) AccumulatedOtherComprehensiveIncome(Loss) Common Stock AdditionalPaid-inCapital AccumulatedDeficit TotalStockholders'Equity Shares Amount Balance atDecember 31,2006 14,066 $141 $234,930 $(82,794)$— $152,277 Net sharesissued inconnectionwith theexercise ofstock optionsand restrictedstock units 372 3 4,520 — — 4,523 Shares issuedin connectionwith afinancing, netof financingcosts of$0.2 million 2,500 25 154,454 — — 154,479 Shares issuedin connectionwithemployeestockpurchase plan 8 — 260 — — 260 Non-cashequity-basedcompensation — — 8,182 — — 8,182 Unrealizedgains onsecurities, net — — — — 127 127 Net loss — — — (33,894) — (33,894) Balance atDecember 31,2007 16,946 169 402,346 (116,688) 127 285,954 Net sharesissued inconnectionwith theexercise ofstock optionsand restrictedstock units 59 1 762 — — 763 The accompanying notes are an integral part of these consolidated financial statements.81Shares issuedin connectionwithemployeestockpurchase plan 13 — 393 — — 393 Non-cashequity-basedcompensation — — 8,037 — — 8,037 Unrealizedlosses onsecurities, net — — — — (10,086) (10,086)Net loss — — — (71,647) — (71,647) Balance atDecember 31,2008 17,018 170 411,538 (188,335) (9,959) 213,414 Net sharesissued inconnectionwith theexercise ofstock optionsand restrictedstock units 304 3 4,044 — — 4,047 Shares issuedin connectionwithemployeestockpurchase plan 41 1 1,155 — — 1,156 Non-cashequity-basedcompensation — — 15,677 — — 15,677 Unrealizedgains onsecurities, netof tax of$1,089 — — — — 2,034 2,034 Net loss — — — (93,351) — (93,351) Balance atDecember 31,2009 17,363 $174 $432,414 $(281,686)$(7,925)$142,977 Table of ContentsAMAG Pharmaceuticals, Inc. Consolidated Statements of Cash Flows (in thousands) Years Ended December 31, 2009 2008 2007 Net loss $(93,351)$(71,647)$(33,894)Cash flows from operating activities: Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 1,913 1,497 798 Non-cash equity-based compensation expense 15,421 8,037 8,182 Non-cash income tax benefit (1,089) — — Amortization of premium/discount on purchased securities 490 482 (1,023) Fair value adjustment on settlement rights 778 (1,566) — Gains (losses) on investments, net (942) 3,024 — Changes in operating assets and liabilities: Accounts receivable (26,942) (185) 126 Inventories (9,063) 288 (40) Prepaid and other current assets (762) (1,910) (1,701) Accounts payable and accrued expenses 13,215 6,596 (121) Deferred revenues 9,682 42 (1,096) Other long-term liabilities (68) 3,006 49 Total adjustments 2,633 19,311 5,174 Net cash used in operating activities (90,718) (52,336) (28,720) Cash flows from investing activities: Proceeds from sales or maturities of available-for-sale investments 74,543 233,194 455,608 Proceeds from maturities of held-to-maturity investments — — 132,795 Purchase of available-for-sale investments (310) (137,438) (693,463) Purchase of held-to-maturity investments — — (110,787) Capital expenditures (2,835) (8,178) (884) Change in restricted cash 61 (426) (61) Net cash provided by (used in) investing activities 71,459 87,152 (216,792) Cash flows from financing activities: Proceeds from the exercise of stock options 4,047 763 4,523 Proceeds from the issuance of common stock under ESPP 1,156 393 260 Proceeds from the issuance of common stock, net of underwriting discountand other expenses — — 154,479 Net cash provided by financing activities 5,203 1,156 159,262 Net (decrease) increase in cash and cash equivalents (14,056) 35,972 (86,250)Cash and cash equivalents at beginning of the year 64,182 28,210 114,460 Cash and cash equivalents at end of the year $50,126 $64,182 $28,210 Supplemental data: Non-cash investing and financing activities: Accrued construction in process $272 $— $— Investments reclassified to trading, at fair value $— $7,650 $— Non-cash stock option exercises $— $— $683 The accompanying notes are an integral part of these consolidated financial statements.82Table of ContentsNotes to Consolidated Financial Statements A. Organization and Business AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company that utilizes our proprietarytechnology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid inthe diagnosis of cancer and cardiovascular disease. We currently manufacture and sell two approved products, Feraheme® (ferumoxytol) Injection forintravenous, or IV, use and GastroMARK®. On June 30, 2009, Feraheme was approved for marketing in the U.S. by the U.S. Food and Drug Administration, or the FDA, for use as an IViron replacement therapy for the treatment of iron deficiency anemia, or IDA, in adult patients with chronic kidney disease, or CKD. We market and sellFeraheme through our own commercial organization and began shipping Feraheme to our customers in July 2009. GastroMARK, our oral contrast agent used for delineating the bowel in magnetic resonance imaging, or MRI, is approved and marketed in theU.S., Europe and other countries through our marketing partners. Feridex I.V.®, our liver contrast agent, has been marketed and sold in the U.S., Europe and other countries for a number of years through ourmarketing partners. In November 2008, we ceased manufacturing Feridex I.V. Accordingly, we have terminated all of our agreements with ourmarketing partners for Feridex I.V. throughout the world and do not intend to continue commercializing Feridex I.V. We are subject to risks common to companies in the pharmaceutical industry including, but not limited to, our sole dependence on the success ofFeraheme, development by us or our competitors of new technological and product innovations, uncertainty regarding market acceptance of ourproducts, uncertainties related to insurance coverage, coding and third-party reimbursement for our products, our limited experience commercializingand distributing a pharmaceutical product, our potential inability to operate our manufacturing facility in compliance with current good manufacturingpractices, or cGMP, our potential inability to obtain raw materials and manufacture sufficient quantities of our products, the potential fluctuation of ouroperating results, potential differences between actual future results and the estimates or assumptions used by us in preparation of our consolidatedfinancial statements, the volatility of our stock price, our potential inability to become profitable in the future, our potential inability to obtain additionalfinancing, if necessary, on acceptable terms, the current credit and financial market conditions, our potential inadvertent failure to comply with reportingand payment obligations under government pricing programs, our potential inadvertent failure to comply with the regulations of the FDA and othergovernment agencies, uncertainty of the regulatory approval process for our other Feraheme indications or outside of the U.S., uncertainty of the resultsof clinical trials, our ability to manage growth, our ability to enter into favorable collaborations and in-licensing arrangements, our dependence on keypersonnel, and uncertainties related to the protection of proprietary technology, product liability, and potential legislative and regulatory changes. Throughout this Annual Report on Form 10-K, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as "theCompany," "we," "us," or "our."B. Summary of Significant Accounting PoliciesUse of Estimates and Assumptions The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of Americarequires management to make certain estimates83Table of Contentsand assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and the related disclosure of contingent assets andliabilities. The most significant estimates and assumptions are used in, but not limited to, revenue recognition and related sales allowances, assessinginvestments for potential other-than-temporary impairment and determining values of investments, reserves for doubtful accounts, accrued expenses,income taxes and equity-based compensation expense. Actual results could differ materially from those estimates.Principles of Consolidation The accompanying consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries, AMAG SecuritiesCorporation and AMAG Europe Limited. AMAG Europe Limited was incorporated in October 2009 in London, England. AMAG SecuritiesCorporation is a Massachusetts corporation that was formed in August 2007. All significant intercompany account balances and transactions betweenthe companies have been eliminated.Cash and Cash Equivalents Cash and cash equivalents consist principally of cash held in commercial bank accounts, money market funds and U.S. Treasury securities havingan original maturity of less than three months. At December 31, 2009 and 2008, substantially all of our cash and cash equivalents were held in eithercommercial banks or money market accounts.Investments We account for and classify our investments as either "available-for-sale," "trading," or "held-to-maturity," in accordance with current guidancerelated to the accounting and classification of certain investments in debt and equity securities. The determination of the appropriate classification by usis based on a variety of factors, including management's intent at the time of purchase. As of December 31, 2009 and 2008, all of our investments wereclassified as either available-for-sale or trading securities. Available-for-sale securities are those securities which we view as available for use in current operations, if needed. We generally classify ouravailable-for-sale securities as short-term investments, even though the stated maturity date may be one year or more beyond the current balance sheetdate. However, due to our belief that the market for auction rate securities, or ARS, may take in excess of twelve months to fully recover, we haveclassified our ARS that are not subject to Settlement Rights as long-term investments. Available-for-sale investments are stated at fair value with theirunrealized gains and losses included as a separate component of stockholders' equity entitled "Accumulated other comprehensive loss," until such gainsand losses are realized or until an unrealized loss is considered other-than-temporary. Trading securities are securities bought and held principally for the purpose of selling them at a later date and are carried at fair value withunrealized gains and losses reported in other income (expense) in our consolidated statements of operations. In November 2008, we elected toparticipate in a rights offering, by UBS AG, or UBS, one of our securities brokers, which provided us with rights to sell to UBS $9.3 million in parvalue of our ARS portfolio, at par value, at any time during a two-year sale period beginning June 30, 2010, or the Settlement Rights. With theopportunity provided by the Settlement Rights, we have designated these ARS as trading securities as we are likely to sell these investments to UBS. Effective April 1, 2009, we adopted a newly issued accounting standard which amended the existing guidance on the recognition and presentationof other-than-temporary impairments on debt and equity securities. This accounting standard establishes a new method of recognizing and reportingother-than-temporary impairments of debt securities and provides additional disclosure requirements84Table of Contentsrelated to debt and equity securities. Prior to our adoption of this new accounting standard, our assessment of the impairment of our investmentsincluded an evaluation of whether a decline in fair value below amortized cost basis was other-than-temporary considering various factors such as theduration of the period that, and extent to which, the fair value was less than cost basis, the financial health of and business outlook for the issuer,including industry and sector performance, operational and financing cash flow factors, overall market conditions and trends, underlying collateral,credit ratings with respect to our investments provided by investments ratings agencies, as well as whether we had the intent and ability to hold aninvestment for a sufficient period of time to recover its value. Under the new accounting standard, for debt securities with a decline in fair value belowamortized cost basis, an other-than-temporary impairment exists if (i) we have the intent to sell the security or (ii) it is more likely than not that we willbe required to sell the security prior to recovery of its amortized cost basis. If either of these conditions is met, we recognize the difference between theamortized cost of the security and its fair value at the impairment measurement date in our consolidated statement of operations. If neither of theseconditions is met, we must perform additional analyses, including evaluation of the security, issuer and environmental factors noted above, to evaluatewhether the unrealized loss is associated with the creditworthiness of the security or is associated with other factors, such as interest rates or marketfactors. If we determine from this analysis that we do not expect to receive cash flows sufficient to recover the entire amortized cost of the security, acredit loss exists, and the impairment is considered other-than-temporary and this amount is recognized in our consolidated statement of operations.There were no impairments previously recognized on securities we owned at March 31, 2009 which would not have been recognized under the newaccounting standard and therefore there was no cumulative effect adjustment to accumulated deficit and other comprehensive loss as a result of adoptingthe accounting standard.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 (anexit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on themeasurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservableinputs. The current accounting guidance also establishes a hierarchy used to categorize how fair value is measured and which is based on three levels ofinputs, of which the first two are considered observable and the last 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, quotedprices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the fullterm 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. We hold certain assets that are required to be measured at fair value on a recurring basis, including our cash equivalents, short- and long-terminvestments and our Settlement Rights. The85Table of Contentsfollowing tables represent the fair value hierarchy for those assets that we measure at fair value on a recurring basis as of December 31, 2009 andDecember 31, 2008 (in thousands): With the exception of our ARS and Settlement Rights, which are valued using Level 3 inputs, as discussed below, the fair value of our non-moneymarket fund investments is primarily determined from independent pricing services which use Level 2 inputs for the determination of fair value.Independent pricing services normally derive security prices from recently reported trades for identical or similar securities, making adjustments basedupon other significant observable market transactions at fair value. At each reporting period, we perform quantitative and qualitative analyses on pricesreceived from third parties to determine whether prices are reasonable estimates of fair value. After completing our analyses, we did not adjust oroverride any fair value measurements provided by our pricing services as of December 31, 2009. We also analyze when the volume and level of activity for an asset or liability have significantly decreased and when circumstances indicate that atransaction may not be considered orderly. In order to determine whether the volume and level of activity for an asset or liability have significantlydecreased, we assess current activity with normal market activity for the asset or liability. We rely on many factors such as trading volume, tradingfrequency, the levels at which market participants indicate their willingness to buy and sell our securities, as reported by market participants, and currentmarket conditions. Using professional judgment and experience, we evaluate and weigh the relevance and significance of all applicable factors todetermine if there has been a significant decrease in the volume and level of activity for an asset or group of similar assets. Similarly, in order to identifytransactions that are not orderly, we take into consideration the activity in the market which can influence the determination and occurrence of an orderlytransaction. Also, we inquire as to whether there may have been restrictions on the marketing of the security to a single or limited number ofparticipants. Where86 Fair Value Measurements at December 31, 2009 Using: Total Quoted Prices inActive Markets forIdentical Assets(Level 1) Significant OtherObservable Inputs(Level 2) SignificantUnobservableInputs(Level 3) Money market funds $46,451 $46,451 $— $— Corporate debt securities 9,804 — 9,804 — U.S. treasury andgovernment agencysecurities 11,247 — 11,247 — Auction rate securities 57,540 — — 57,540 Settlement rights 788 — — 788 $125,830 $46,451 $21,051 $58,328 Fair Value Measurements at December 31, 2008 Using: Total Quoted Prices inActive Markets forIdentical Assets(Level 1) Significant OtherObservable Inputs(Level 2) SignificantUnobservable Inputs(Level 3) Money market funds $60,403 $60,403 $— $— Corporate debt securities 54,320 — 54,320 — U.S. treasury andgovernment agencysecurities 37,094 — 37,094 — Commercial paper 3,500 — 3,500 — Auction rate securities 54,335 — — 54,335 Settlement rights 1,566 — — 1,566 $211,218 $60,403 $94,914 $55,901 Table of Contentspossible, we assess the financial condition of the seller to determine whether observed transactions may have been forced. If the trading price for asecurity held by us is significantly out of line when compared to the trading prices of similar recent transactions, we consider whether this disparity is anindicator of a disorderly trade. Using professional judgment and experience, we evaluate and weigh the relevance and significance of all applicablefactors to determine if the evidence suggests that a transaction or group of similar transactions is not orderly. Based upon these procedures, wedetermined that market activity for our assets appeared normal and that transactions did not appear disorderly as of December 31, 2009. In November 2008, we elected the fair value option with respect to our Settlement Rights in accordance with accounting guidance related to the fairvalue option for financial assets and financial liabilities. We are required to assess the fair value of both the Settlement Rights and our ARS subject toSettlement Rights and record changes each period until the Settlement Rights are exercised and our ARS subject to Settlement Rights are redeemed.Although the Settlement Rights represent the right to sell the securities back to UBS at par, we are required to periodically assess the ability of UBS tomeet that obligation in assessing the fair value of the Settlement Rights. The following table presents assets measured at fair value on a recurring basis using significant unobservable inputs (Level 3) as of December 31,2009 and 2008 (in thousands): Gains and losses (realized and unrealized) included in earnings in the table above are reported in other income (expense) in our consolidatedstatement of operations.Inventories Inventories are stated at the lower of cost or market (net realizable value), with approximate cost being determined on a first-in, first-out basis. Prior to approval from the FDA or other regulatory agencies, we expense costs relating to the production of inventory in the period incurred untilsuch time as we receive approval. Upon approval from the FDA, or other regulatory agencies, we then begin to capitalize the subsequent inventorycosts related to the product. Prior to the FDA approval of Feraheme for commercial sale in June 2009, all production costs related to Feraheme wereexpensed to research and development. Subsequent to receiving FDA approval, costs related to the production of Feraheme are capitalized to inventory,including the costs of converting previously existing raw materials to inventory and vialing, labeling, and packaging inventory manufactured prior toapproval whose costs had already been recorded as research and development expense. Until we sell the inventory for which a portion of the costs werepreviously expensed, the carrying value of our inventories and our cost of product sales will reflect only incremental costs incurred subsequent to theapproval date. We continue to expense costs associated with clinical trial material as research and development expense.87 December 31, 2009 December 31, 2008 Balance at beginning of period $55,901 $— Transfers to Level 3 — 80,725 Total gains (losses) (realized or unrealized): Included in earnings 99 (109) Included in other comprehensive income (loss) 3,378 (10,515)Purchases (settlements), net (1,050) (14,200) Balance at end of period $58,328 $55,901 The amount of total gains (losses) for the period included in earningsattributable to the change in unrealized gains (losses) relating to assets stillheld at end of period $— $(109) Table of ContentsProperty, Plant and Equipment Property, plant and equipment are recorded at cost and depreciated when placed into service using the straight line method, based on the followingestimated useful lives: buildings—40 years; building improvements—over the shorter of the remaining useful life of the building or the life of theimprovement; laboratory and production equipment—5 years; and furniture and fixtures—5 years. The furniture, fixtures, and leasehold improvementsassociated with our facility lease are being depreciated over the shorter of their useful lives or the remaining life of the original lease (excluding optionallease renewal terms). Costs for capital assets not yet placed in service are capitalized on our balance sheet, and the cost of maintenance and repairs is expensed asincurred. Upon sale or other disposition of property and equipment, the cost and related depreciation are removed from the accounts and any resultinggain or loss is charged to our consolidated statement of operations. Currently, our long-lived assets consist entirely of property and equipment. Long-lived assets to be held and used are evaluated for impairment whenever events or changes in circumstances indicate that the carrying value of the assetmay not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the assetand its eventual disposition. In the event such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets arewritten down to their estimated fair values.Patents We expense all patent-related costs as incurred.Research and Development Expenses Research and development expenses include external expenses, such as costs of clinical trials, contract research and development expenses, certainmanufacturing research and development costs, consulting and professional fees and expenses, and internal expenses, such as compensation ofemployees engaged in research and development activities, the manufacture of product needed to support research and development efforts, related costsof facilities, and other general costs related to research and development. Manufacturing costs are expensed as incurred until a product has received thenecessary initial regulatory approval.Advertising Costs Advertising costs are expensed as incurred and are included in selling, general and administrative expenses in our consolidated statement ofoperations. Advertising costs, including promotional expenses and costs related to trade shows were $7.5 million, $3.8 million and $1.1 million for theyears ended December 31, 2009, 2008 and 2007, respectively.88Table of ContentsRevenue RecognitionNet Product Sales We recognize net product sales in accordance with current accounting guidance related to the recognition, presentation and disclosure of revenue infinancial statements, which outlines the basic criteria that must be met to recognize revenue. We recognize revenue when:•persuasive evidence of an arrangement exists; •delivery of product has occurred or services have been rendered; •the sales price charged is fixed or determinable; and •collection is reasonably assured. We record product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and other rebates, distributor,wholesaler and group purchasing organization, or GPO, fees, and product returns as a reduction of revenue in our consolidated statement of operationsat the time product sales are recorded. Calculating these gross-to-net sales adjustments involves estimates and judgments based primarily on actualFeraheme sales data and forecasted customer buying patterns blended with historical experience of products similar to Feraheme sold by others.Because we only recently launched Feraheme in the U.S. there are a number of factors that make it particularly difficult to predict the magnitude offuture Feraheme sales, including the magnitude and timing of adoption of Feraheme by physicians, dialysis clinics, hospitals and other healthcarepayors and providers, the inventory levels maintained by Feraheme wholesalers, distributors and other customers, the frequency of re-orders byexisting customers, and the pricing of products that compete with Feraheme and other actions taken by our competitors. In addition, we also monitorour distribution channel to determine whether additional allowances or accruals are required based on inventory in our sales channel. There were noproduct sales allowances or accruals for the year ended December 31, 2008. An analysis of our product sales allowances and accruals for the yearended December 31, 2009 is as follows (in thousands): Product sales allowances and accruals are comprised of both direct and indirect fees, discounts and rebates. Direct fees, discounts and rebates arecontractual 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 dialysisorganizations, physicians, clinics, hospitals, and GPOs that typically do not purchase products directly from us but rather from wholesalers andspecialty distributors. In accordance with guidance related to accounting for fees and consideration given by a vendor to a customer (including a resellerof a vendor's products), these fees, discounts and rebates are presumed to be a reduction of the selling price of Feraheme. Product sales allowances andaccruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and89 December 31, 2009 Product sales allowances and accruals: Discounts and chargebacks $804 Government and other rebates 4,329 Returns 463 Total product sales allowances and accruals $5,596 Total net product sales $16,482 Total gross product sales $22,078 Total product sales allowances and accruals as a percent of total gross product sales 25%Table of Contentsregulations) related to the purchase and/or utilization of the product by these entities. Allowances and accruals are generally recorded in the same periodthat the related revenue is recognized and are estimated using either historical, actual and/or other data, including estimated patient usage, applicablecontractual rebate rates, contract performance by the benefit providers, other current contractual and statutory requirements, historical market data basedupon experience of other similar products to Feraheme, specific known market events and trends such as competitive pricing and new productintroductions and current and forecasted customer buying patterns and inventory levels, including the shelf life of our products. As part of thisevaluation, we also review changes to federal legislation, changes to rebate contracts, changes in the level of discounts, and changes in product salestrends. Reserve estimates are evaluated quarterly and may require adjustments to better align our estimates with actual results. Although allowances andaccruals 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. If actualfuture results vary from our estimates, we may need to adjust our previous estimates, which would affect our earnings in the period of the adjustment.Classification of Product Sales Allowances and Accruals Allowances against receivable balances primarily relate to prompt payment discounts, provider chargebacks and certain government agencychargebacks and are recorded at the time of sale, resulting in a reduction in product sales revenue or deferred revenue and the reporting of product salesreceivables net of allowances. Accruals related to Medicaid and provider volume rebates, wholesaler and distributor fees, GPO fees, other discounts tohealthcare providers and product returns are recorded at the time of sale, resulting in a reduction in product sales revenue and the recording of anincrease in accrued expenses.Discounts We typically offer a 2% prompt payment discount to our customers as an incentive to remit payment in accordance with the stated terms of theinvoice. Because we anticipate that those customers who are offered this discount will take advantage of the discount, we accrue 100% of the promptpayment discount, based on the gross amount of each invoice, at the time of sale. We adjust the accrual quarterly to reflect actual experience.Chargebacks Chargeback reserves represent our estimated obligations resulting from the difference between the prices at which we sell Feraheme to wholesalersand the sales price ultimately paid to wholesalers under fixed price contracts by third-party payors, including governmental agencies. We determine ourchargeback estimates based on actual Feraheme sales data and forecasted customer buying patterns blended with historical experience of productssimilar to Feraheme sold by others, supplemented with other market research data related to demand patterns for iron replacement therapies which havebeen marketed for the past several years. Actual chargeback amounts are determined at the time of resale to the qualified healthcare provider, and wegenerally issue credits for such amounts within several weeks of receiving notification from the wholesaler. Estimated chargeback amounts are recordedat the time of sale, and we adjust the accrual quarterly to reflect actual experience.Governmental and Other Rebates Governmental and other rebate reserves relate to our reimbursement arrangements with state Medicaid programs or performance rebate agreementswith certain classes of trade. We determine our estimates for Medicaid rebates based on market research data related to utilization rates by various end-users and actual Feraheme sales data and forecasted customer buying patterns blended with historical experience of products similar to Feraheme soldby others. For rebates associated with90Table of Contentsreaching defined performance goals, we determine our estimates using actual Feraheme sales data and forecasted customer buying patterns blended withhistorical experience of products similar to Feraheme sold by others. Rebate amounts generally are invoiced quarterly and are paid in arrears, and weexpect to pay such amounts within several weeks of notification by the Medicaid or provider entity. We adjust the accrual quarterly to reflect actualexperience.Distributor/Wholesaler and Group Purchasing Organization Fees Fees under our arrangements with distributors and wholesalers are usually based upon units of Feraheme purchased during the prior month orquarter and are usually paid by us within several weeks of our receipt of an invoice from the wholesaler or distributor, as the case may be. Fees underour arrangements with certain GPOs are usually based upon member purchases during the prior quarter and are generally billed by the GPO within30 days after period end. Current accounting standards related to consideration given by a vendor to a customer, including a reseller of a vendor'sproducts, specify that cash consideration given by a vendor to a customer is presumed to be a reduction of the selling price of the vendor's products orservices and therefore should be characterized as a reduction of revenue. Consideration should be characterized as a cost incurred if we receive, or willreceive, an identifiable benefit (goods or services) in exchange for the consideration and we can reasonably estimate the fair value of the benefitreceived. Because the fees we pay to wholesalers do not meet the foregoing conditions to be characterized as a cost, we have characterized these fees asa reduction of revenue. We generally pay such amounts within several weeks of our receipt of an invoice from the distributor, wholesaler, or GPO.Accordingly, we accrue 100% of the fee due, based on the gross amount of each invoice to the customer, at the time of sale. We adjust the accrualquarterly to reflect actual experience.Product Returns Consistent with industry practice, we generally offer our distributors and wholesaler customers a limited right to return product purchased directlyfrom us which is principally based upon the product's expiration date. We currently estimate product returns based upon historical trends in thepharmaceutical industry and trends for products similar to Feraheme sold by others. We track actual returns by individual production lots. Returns onlots eligible for credits under our returned goods policy are monitored and compared with historical return trends and rates. In addition to the factors discussed above, we consider several additional factors in our estimation process, including our internal sales forecastsand inventory levels in the distribution channel. We expect that wholesalers will not stock significant inventory due to the product's cost and expense tostore. When considering the level of inventory in the distribution channel, we determine whether an adjustment to the sales return reserve is appropriate.For example, if levels of inventory in the distribution channel increase and we believe sales returns will be larger than expected, we would adjust thesales return reserve, taking into account historical experience, our returned goods policy and the shelf life of our product, which, once packaged, iscurrently 24 months. If necessary, our estimated rate of returns may be adjusted for historical return patterns as they become available and for known or expectedchanges in the marketplace. To date, returns and adjustments to our estimated rate of returns have been minimal. If we were to reduce our productreturns estimate in the future, doing so would result in increased product sales at the time the return estimate is reduced. If circumstances change orconditions become more competitive in the iron replacement therapy market, we may increase our product returns estimate, which would result in anincremental reduction of product sales at the time the returns estimate is changed.91Table of ContentsDeferred Revenue—Launch Incentive Program During the third quarter of 2009, certain dialysis organizations purchased Feraheme from us under our Launch Incentive Program. Thesepurchases were made under agreements which provided these customers with an opportunity to purchase Feraheme through September 30, 2009 atdiscounted pricing and further provided for extended payment terms and expanded rights of return. As a result, in accordance with current accountingguidance which requires that we defer recognition of revenues until we can reasonably estimate returns related to those shipments, we have deferred therecognition of revenues associated with these purchases until our customers report to us that such inventory has been utilized in their operations. Anypurchases returned to us will not be recorded as revenue. Accordingly, as of December 31, 2009, we recorded $10.2 million in deferred revenues,representing all product purchased under the Launch Incentive Program which remained held by the dialysis organizations at December 31, 2009, net ofany applicable discounts and estimated rebates, which are included in our commercial rebate accruals as of December 31, 2009. In addition, we havedeferred the related cost of product sales of approximately $0.3 million and recorded such amount as finished goods inventory held by others as ofDecember 31, 2009. Because we are unable to reasonably estimate the amount of inventory that may be returned under this program, if any, we cannotprovide any assurance that amounts reported as deferred revenue and associated with this program will be utilized by our customers and therebyrecorded by us as product revenues in our future consolidated statements of operations.License Fee Revenues The terms of product development agreements entered into between us and our collaborative partners may include non-refundable license fees,payments based on the achievement of certain milestones and royalties on any product sales derived from those collaborations. We recognize license feeand research and development revenue under collaborative arrangements over the term of the applicable agreements through the application of aproportional performance model where revenue is recognized equal to the lesser of the amount due under the agreements or the amount based on theproportional performance to date. In cases where project costs or other performance metrics are estimable, we recognize nonrefundable payments andfees for the licensing of technology or intellectual property rights over the related performance period or when there are no remaining performanceobligations. In cases where project costs or other performance metrics are not estimable but there is an established contract period, revenues arerecognized on a straight line basis over the term of the relevant agreement. Nonrefundable payments and fees are recorded as deferred revenue uponreceipt and may require deferral of revenue recognition to future periods.Royalty Revenues We receive royalty revenues under license and marketing agreements with several companies that sell products that we developed. The licenseagreements provide for the payment of royalties to us based on sales of the licensed product. As we do not have the ability to reliably estimate ourroyalties in any given period, we recognize royalty revenue when cash payments are received.Multiple Element Arrangements We evaluate revenue from arrangements that have multiple elements to determine whether the components of the arrangement represent separateunits of accounting as defined in the accounting guidance related to revenue arrangements with multiple deliverables which provides that an element of acontract can be accounted for separately if the delivered elements have stand-alone value and the fair value of any undelivered elements is determinable.If an element is considered to have standalone value but the fair value of any of the undelivered items cannot be determined, all elements of the92Table of Contentsarrangement are recognized as revenue over the period of performance for such undelivered items or services.Shipping and Handling Costs During 2009, we began to utilize a third party logistics provider, which is a subsidiary of one of our distribution customers, to provide us withvarious shipping and handling services related to sales of Feraheme. Current accounting standards related to consideration given by a vendor to acustomer, including a reseller of a vendor's products, specify that cash consideration given by a vendor to a customer is presumed to be a reduction ofthe selling price of the vendor's products or services and therefore should be characterized as a reduction of revenue. However, that presumption isovercome and the consideration should be characterized as a cost incurred if both of the following conditions are met:•we receive, or will receive, an identifiable benefit (goods or services) in exchange for the consideration; and •we can reasonably estimate the fair value of the benefit received. Since both of the above conditions were met with respect to the costs we incurred for shipping and handling services, we have recorded$0.1 million as a selling, general and administrative expense during the year ended December 31, 2009.Equity-Based Compensation Under the fair value recognition guidance of equity-based compensation accounting rules, equity-based compensation cost is generally required tobe measured at the grant date (based upon an estimate of the fair value of the compensation granted) and recorded to expense over the requisite serviceperiod, which generally is the vesting period. Because equity-based compensation expense is based on awards ultimately expected to vest, we mustmake certain judgments about whether employees and directors will complete the requisite service period. Accordingly, we have reduced thecompensation expense being recognized for estimated forfeitures. Under the current accounting guidance, forfeitures are estimated at the time of grantand revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based upon historicalexperience. If factors change and we employ different assumptions in future periods, the compensation expense that we record in the future may differsignificantly from what we have recorded in the current period. We estimate the fair value of equity-based compensation involving stock options based on the Black-Scholes option pricing model. We estimate thefair value of our restricted stock units whose vesting is contingent upon market conditions using the Monte-Carlo simulation model. These modelsrequire the input of several factors such as the expected option term, the expected risk-free interest rate over the expected option term, the expectedvolatility of our stock price over the expected option term, and the expected dividend yield over the expected option term and are subject to variousassumptions. The fair value of awards whose fair values are calculated using the Black-Scholes option pricing model are generally being amortized on astraight line basis over the requisite service period and is recognized based on the proportionate amount of the requisite service period that has beenrendered during each reporting period. The fair value of awards with market conditions are being amortized based upon the estimated derived serviceperiod. We believe our valuation methodologies are appropriate for estimating the fair value of equity awards we grant to employees and directors. Ourequity award valuations are estimates and thus may not be reflective of actual future results or amounts ultimately realized by recipients of these grants.These amounts, and the amounts applicable to future quarters, are also subject to future quarterly adjustments based upon a variety of factors, whichinclude, but are not limited to, changes in estimated forfeiture rates and the issuance of new equity-based93Table of Contentsawards. The fair value of restricted stock units granted to employees and directors is determined based upon the quoted closing market price per shareon the date of grant, adjusted for assumed forfeitures. As with any accounting policy that applies judgments and estimates, actual results couldsignificantly differ from those estimates which could result in a material and/or adverse impact to our financial results. Equity-based compensation to certain non-employees is accounted for in accordance with current accounting guidance related to the accounting forequity instruments that are issued to other than employees for acquiring, or in conjunction with selling, goods or services.Income Taxes Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assetsand liabilities using future enacted rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of ourdeferred tax assets will not be realized.Concentrations and Significant Customer Information Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash equivalents, investments, accountsreceivable and Settlement Rights. As of December 31, 2009, our cash equivalents, investments and Settlement Rights amounted to approximately$125.8 million. We currently invest our excess cash primarily in institutional and U.S. government and agency money market funds and investments incorporate debt securities, U.S. treasury and government agency securities, and ARS. Our operations are located solely within the U.S. We are focused principally on developing, manufacturing, and commercializing an IV ironreplacement therapeutic agent and novel imaging agents. 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 revenues for the years ended December 31, 2009, 2008 and 2007. Noother company accounted for more than 10% of our total revenues in any period presented below. All of the revenue attributable to Cytogen Corporation and a large portion of the revenue attributable to Bayer Healthcare Pharmaceuticals, orBayer, in the relevant periods presented was the result of previously deferred revenue related to up-front license fees that were either amortized intorevenue on a straight line basis or amortized over the period of the estimated performance obligation. Revenues from customers outside of the U.S., principally in Europe, amounted to 2%, 29%, and 28%, of our total revenues for the years endedDecember 31, 2009, 2008 and 2007, respectively. Certain raw materials used in our products are procured from a single source. We sometimes obtain raw materials from one vendor only, evenwhere multiple sources are available, to maintain quality control and enhance working relationships with suppliers.94 For the Years EndedDecember 31, 2009 2008 2007 AmerisourceBergen Drug Corporation 46% — — Metro Medical Supply, Inc. 28% — — Bayer Healthcare Pharmaceuticals <10% 53% 43%Guerbet S.A. <10% 24% 26%Covidien, Ltd. <10% 17% 15%Cytogen Corporation — — 14%Table of ContentsComprehensive Income (Loss) The current accounting guidance related to comprehensive income (loss) requires us to display comprehensive loss and its components as part ofour consolidated financial statements. Our comprehensive loss consists of net loss and other comprehensive income (loss). Other comprehensiveincome (loss) includes changes in equity that are excluded from net loss, which for all periods presented related to unrealized holding gains and losseson available-for-sale investments.Net Loss per Share We compute basic net loss per share by dividing net loss by the weighted average number of common shares outstanding during the relevantperiod. The following table sets forth the potential common shares issuable upon the exercise of outstanding options and restricted stock units (prior toconsideration of the treasury stock method), the total of which was excluded from our computation of diluted net loss per share because such optionsand restricted stock units were anti-dilutive due to a net loss in the relevant periods (in thousands): The components of basic and diluted net loss per share were as follows (in thousands, except per share data): In January 2010, we increased our shares outstanding by selling 3,600,000 shares of our common stock, $0.01 par value per share, in anunderwritten public offering.Reclassifications Certain amounts in prior periods have been reclassified in order to conform to the current period presentation.C. Investments At December 31, 2009 and December 31, 2008, our total aggregate short-and long-term investments totaled $78.6 million and $149.2 million,respectively, and consisted of securities classified as trading and available-for-sale in accordance with accounting standards which provide guidancerelated to accounting and classification of certain investments in debt and equity securities.95 Years Ended December 31, 2009 2008 2007 Options to purchase shares of common stock 2,416 1,991 1,327 Shares of common stock issuable upon the vesting of restricted stock units 216 219 36 Total 2,632 2,210 1,363 Years Ended December 31, 2009 2008 2007 Net loss $(93,351)$(71,647)$(33,894)Weighted average common shares outstanding 17,109 16,993 15,777 Net loss per share: Basic and diluted $(5.46)$(4.22)$(2.15)Table of Contents The following is a summary of our available-for-sale and trading securities at December 31, 2009 and 2008 (in thousands): December 31, 2009 AmortizedCost GrossUnrealizedGains GrossUnrealizedLosses EstimatedFairValue Short-term investments: Corporate debt securities Due in one year or less $8,580 $61 $— $8,641 Due in one to three years 1,117 46 — 1,163 U.S. treasury and government agency securities Due in one year or less 8,532 136 — 8,668 Due in one to three years 2,521 58 — 2,579 Auction rate securities—trading Due in one year or less — — — — Due after five years 8,527 — — 8,527 Total short-term investments $29,277 $301 $— $29,578 Long-term investments: Auction rate securities—available for sale Due in one year or less $— $— $— $— Due after five years 56,150 — (7,137) 49,013 Total long-term investments $56,150 $— $(7,137)$49,013 Total short and long-term investments $85,427 $301 $(7,137)$78,591 December 31, 2008 AmortizedCost GrossUnrealizedGains GrossUnrealizedLosses EstimatedFairValue Short-term investments: Corporate debt securities Due in one year or less $42,845 $106 $(263)$42,688 Due in one to three years 11,647 58 (73) 11,632 U.S. treasury and government agency securities Due in one year or less 18,184 235 — 18,419 Due in one to three years 18,183 492 — 18,675 Commercial paper Due in one year or less 3,499 1 — 3,500 Due in one to three years — — — — Total short-term investments $94,358 $892 $(336)$94,914 Long-term investments: Auction rate securities—available for sale Due in one year or less $— $— $— $— Due after five years 57,200 — (10,515) 46,685 Auction rate securities—trading Due in one year or less — — — — Due after five years 7,650 — — 7,650 Total long-term investments $64,850 $— $(10,515)$54,335 96Total short and long-term investments $159,208 $892 $(10,851)$149,249 Table of ContentsAuction Rate Securities and UBS Settlement Rights At December 31, 2009, we held a total of $57.5 million in fair market value of ARS, reflecting an impairment of approximately $7.9 millioncompared to the par value of these securities of $65.4 million. Of the $7.9 million impairment, approximately $7.1 million was considered a temporaryimpairment and was reported as an unrealized loss at December 31, 2009. The remaining $0.8 million represents a trading loss associated with our UBSARS, the recording of which is described below. Of our total ARS, $49.0 million in fair market value are not subject to Settlement Rights and areclassified as available-for-sale. The remaining $8.5 million are subject to Settlement Rights and are classified as trading securities. At December 31,2009, all of our ARS were municipal bonds with an auction reset feature. The substantial majority of our ARS portfolio was rated AAA as ofDecember 31, 2009 by at least one of the major securities rating agencies and were primarily collateralized by student loans substantially guaranteed bythe U.S. government under the Federal Family Education Loan Program. We had traditionally recorded these investments at cost, which approximatedfair market value due to their variable interest rates. Prior to February 2008, these ARS typically reset through an auction process every 7 or 28 days,which generally allowed existing investors to either roll over their holdings and continue to own their securities or liquidate their holdings by sellingtheir securities at par value. In February 2008, our ARS began to experience failed auctions and have continued to experience failed auctions. As a resultof the lack of observable ARS market activity, we changed our valuation methodology for these securities to a discounted cash flow analysis asopposed to valuing them at par value. Our valuation analysis considers, among other items, assumptions that market participants would use in theirestimates of fair value, such as the collateral underlying the security, the creditworthiness of the issuer and any associated guarantees, credit ratings ofthe security by the major securities rating agencies, the ability or inability to sell the investment in an active market, the timing of expected future cashflows, and the expectation of the next time the security will have a successful auction or when call features may be exercised by the issuer. Based uponthis methodology, we have estimated the fair value of our ARS subject to Settlement Rights to be $8.5 million at December 31, 2009 and, accordingly,we recorded realized gains of approximately $0.9 million during the year ended December 31, 2009. In addition, based upon this methodology, we haveestimated the fair value of our remaining ARS not subject to Settlement Rights to be $49.0 million at December 31, 2009, and have recorded a$7.1 million unrealized loss to accumulated other comprehensive loss as of December 31, 2009. As discussed in greater detail below, for all available-for-sale debt securities with unrealized losses, management performs an analysis to assess whether we intend to sell or whether we would more likelythan not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be requiredto do so, the security's decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is recorded in our condensedconsolidated statement of operations as an impairment loss. Regardless of our intent to sell a security, we perform additional analyses on all securitieswith unrealized losses to evaluate whether there could be a credit loss associated with the security. We did not recognize any credit losses related to oursecurities during the year ended December 31, 2009. We believe that the temporary impairment related to our ARS not subject to Settlement Rights isprimarily attributable to the liquidity of these investments, coupled with the ongoing turmoil in the credit and capital markets. As of December 31, 2009,all of our ARS continue to pay interest according to their stated terms. In November 2008, we elected to participate in a rights offering by UBS which provided us with the right to sell to UBS $9.3 million in par valueof our ARS portfolio, at par value, at any time during a two-year sale period beginning June 30, 2010. By electing to participate in the rights offering,we granted UBS the right, exercisable at any time prior to June 30, 2010 or during the two-year sale period, to purchase or cause the sale of our ARS atpar value, or the Call Right. UBS has stated that it will only exercise the Call Right for the purpose of restructurings, dispositions or other solutions thatwill provide its clients with par value for their ARS. UBS has agreed to pay its clients the par value of their ARS within one day of settlement of anyCall Right transaction. Notwithstanding the Call Right,97Table of Contentswe are permitted to sell the ARS to parties other than UBS, which would extinguish the Settlement Rights. In accordance with current accounting guidance related to the fair value option for financial assets and financial liabilities, we have recorded anasset equal to the estimated fair value of the Settlement Rights of approximately $0.8 million in our consolidated balance sheet at December 31, 2009.This represents a decrease of approximately $0.8 million to the estimated fair value of our Settlement Rights from the estimated fair value atDecember 31, 2008, which we have recorded in other income (expense) in our consolidated statement operations. We estimate the fair value of theseSettlement Rights utilizing a discounted cash flow analysis. Certain key assumptions used in this valuation include the estimated value of these rights atthe future date of settlement, the expected term until the date of settlement, and the risk that UBS will not be able to perform under the agreement. Withthe opportunity provided by the Settlement Rights, we have designated the UBS ARS with a par value of $9.3 million and an estimated fair value of$8.5 million as of December 31, 2009, as trading securities as we are likely to sell these investments to UBS. Accordingly, as of December 31, 2009,we have recognized gains of approximately $0.9 million to other income (expense) in our consolidated statement of operations during the year endedDecember 31, 2009. We are required to assess the fair value of both the Settlement Rights and our ARS subject to Settlement Rights and record changeseach period until the Settlement Rights are exercised or our ARS subject to Settlement Rights are redeemed. Although the Settlement Rights representthe right to sell the securities back to UBS at par, we are required to periodically assess the ability of UBS to meet its obligations in assessing the fairvalue of the Settlement Rights. Due to our belief that the market for ARS may take in excess of twelve months to fully recover, we have classified our portfolio of ARS notsubject to Settlement Rights as long-term investments in our consolidated balance sheet at December 31, 2009. As discussed in greater detail below, webelieve that the temporary impairment related to our ARS not subject to Settlement Rights is primarily attributable to the liquidity of these investments,coupled with the ongoing turmoil in the credit and capital markets, and we have no reason to believe that any of the underlying issuers of our ARS arepresently at risk of default. Any future fluctuation in fair value related to our ARS not subject to Settlement Rights that we deem to be temporary,including any recoveries of previous write-downs, would be recorded to accumulated other comprehensive loss. If we determine that any futureunrealized loss is other-than-temporary, we will record a charge to our consolidated statement of operations. In the event that we need to access ourinvestments in these securities, we will not be able to do so until a future auction is successful, the issuer calls the security pursuant to a mandatorytender or redemption prior to maturity, a buyer is found outside the auction process, or the securities mature. For all of our ARS, the underlyingmaturity date is in excess of one year, and the majority have final maturity dates of 30 to 40 years in the future. We believe we will ultimately be able toliquidate our investments without significant loss prior to the maturity dates noted above primarily due to the collateral securing most of our ARS.However, it could take until final maturity of the ARS to realize our investments' par value. In addition, as part of our determination of the fair value ofour investments, we consider credit ratings provided by independent investment rating agencies as of the valuation date. These ratings are subject tochange, and we may be required to adjust our future valuation of these ARS which may adversely affect the value of these investments.Impairments and Unrealized Gains and Losses on Investments The following is a summary of the fair value of our investments with unrealized losses that are deemed to be temporarily impaired and theirrespective gross unrealized losses aggregated by98Table of Contentsinvestment category and length of time that individual securities have been in a continuous unrealized loss position at December 31, 2009 and 2008 (inthousands): As noted above, for available-for-sale debt securities with unrealized losses, we perform an analysis to assess whether we intend to sell or whetherwe would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell asecurity, or may be required to do so, the security's decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized lossis recorded in our consolidated statement of operations as an impairment loss. Regardless of our intent to sell a security, we perform additional analyseson all securities with unrealized losses to evaluate whether there could be a credit loss associated with the security. Our assessment of whether unrealized losses are other-than-temporary requires significant judgment. Factors we consider in making this judgmentinclude, but are not limited to:•the extent to which market value is less than the cost basis; •the length of time that the market value has been less than the cost basis; •whether the unrealized loss is event-driven, credit-driven or a result of changes in market interest rates or risk premium; •the investment's rating and whether the investment is investment-grade and/or has been downgraded since its purchase; •whether the issuer is current on all payments in accordance with the contractual terms of the investment and is expected to meet all of itsobligations under the terms of the investment; •our intent not to sell an impaired investment before its recovery occurs; •whether it is more likely than not that we will be required to sell the investment before recovery occurs; •any underlying collateral and the extent to which the recoverability of the carrying value of our investment may be affected by changes insuch collateral; •unfavorable changes in expected cash flows; and • December 31, 2009 Less than 12 Months 12 Monthsor Greater Total FairValue UnrealizedLosses FairValue UnrealizedLosses FairValue UnrealizedLosses Auction ratesecurities $— $— $49,013 $(7,137)$49,013 $(7,137) $— $— $49,013 $(7,137)$49,013 $(7,137) December 31, 2008 Less than 12 Months 12 Monthsor Greater Total FairValue UnrealizedLosses FairValue UnrealizedLosses FairValue UnrealizedLosses Corporate debtsecurities $33,996 $(295)$963 $(41)$34,959 $(336)Auction ratesecurities 46,685 (10,515) — — 46,685 (10,515) $80,681 $(10,810)$963 $(41)$81,644 $(10,851) •other subjective factors.99Table of Contents Based upon our evaluation, we did not consider the unrealized losses on our available-for-sale investments at December 31, 2009 and 2008 to beother-than-temporarily impaired. Accordingly, no impairment losses were recognized in our consolidated statements of operations related to available-for-sale securities during the years ended December 31, 2009 or 2008. Future events may occur, or additional information may become available, which may cause us to identify credit losses where we do not expect toreceive cash flows sufficient to recover the amortized cost basis of a security and which may necessitate the recording of future realized losses onsecurities in our portfolio. Significant losses in the estimated fair values of our investments could have a material adverse effect on our earnings in futureperiods.Realized Gains and Losses Gains and losses are determined on the specific identification method and, accordingly, during 2009 we recorded gains of $0.2 million to ourconsolidated statements of operations principally related to our estimated valuation of ARS subject to Settlement Rights.D. Accounts Receivable Our accounts receivable were $27.4 million and $0.4 million at December 31, 2009 and 2008, respectively. At December 31, 2009, our accountsreceivable primarily represented amounts due from wholesalers and distributors to whom we sell Feraheme directly and customers who participated inthe Launch Incentive Program. Our accounts receivable at December 31, 2008 primarily represented amounts due from our GastroMARK and FeridexI.V. customers. Accounts receivable are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance fordoubtful accounts. Reserves for other sales related allowances such as rebates, distribution and other fees, and product returns are included in accruedexpenses in our condensed consolidated balance sheet. Included within our accounts receivable balance at December 31, 2009 are $12.1 million in receivables, which represent amounts due from dialysisorganizations to whom we shipped Feraheme under the 2009 Launch Incentive Program. These shipments were made under agreements whichprovided these customers with an opportunity to purchase Feraheme through September 30, 2009 at discounted pricing and further provided forextended payment terms and expanded rights of return. As a result, we have recorded deferred revenues of $10.2 million net of any applicable discountsand estimated rebates as of December 31, 2009 in accordance with current revenue recognition standards. To date, we have not experienced significant bad debts. As part of our credit management policy, we perform ongoing credit evaluations of ourcustomers and as a result have not required collateral from any customer. As a result, we have not established an allowance for doubtful accounts ateither December 31, 2009 or 2008. If the financial condition of our customers was to deteriorate and result in an impairment of their ability to makepayments owed to us, an allowance for doubtful accounts may be required which could have a material effect on earnings in the period of any suchadjustment.100Table of ContentsCustomers with amounts that represented greater than 10% of our accounts receivable balance at December 31, 2009 and 2008 were as follows:E. Inventories Our major classes of inventories were as follows at December 31, 2009 and 2008 (in thousands): Finished goods inventory held by others primarily relates to inventories held by dialysis organizations to which we have shipped Feraheme underthe Launch Incentive Program. Agreements entered into under this program provided certain customers with extended payment terms and expandedrights of return. As a result, in accordance with current accounting and reporting standards related to revenue recognition, we have deferred both therecognition of revenues and the costs of the inventory sold under this program and presented inventories held by others as a separate component of ouroverall inventory as of December 31, 2009. On a quarterly basis, we analyze our inventory levels to determine whether we have any obsolete, expired, or excess inventory. If any inventory isexpected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined byinternal sales forecasts, or fails to meet commercial sale specifications, the inventory is written-down through a charge to cost of goods sold. Thedetermination of whether inventory costs will be realizable requires estimates by management. A critical input in this determination is future expectedinventory requirements, based on internal sales forecasts. Once packaged, Feraheme currently has a shelf-life of 24 months, and as a result ofcomparison to internal sales forecasts, we expect to fully realize the carrying value of our current Feraheme inventory. If actual market conditions areless favorable than those projected by management, additional inventory write-downs may be required. Charges for inventory write-downs are notreversed if it is later determined that the product is saleable. Equity-based compensation of $0.3 million was capitalized into inventory for the year ended December 31, 2009. There was no equity-basedcompensation capitalized into inventory for the year ended December 31, 2008.101 As of December 31, 2009 2008 AmerisourceBergen Drug Corporation 29% — Metro Medical Supply, Inc. 20% — Dialysis Clinics, Inc. 15% — Liberty Dialysis, LLC 10% — Satellite Healthcare, Inc.* 10% — Covidien, Ltd. — 72%Bayer Healthcare Pharmaceuticals — 17%Taejoon Pharmaceutical Co., Ltd — 11%*During 2009, we entered into an agreement with Satellite Healthcare, Inc., or Satellite, a dialysis organization,under which Satellite purchased $2.8 million of Feraheme pursuant to our Launch Incentive Program. Our ChiefExecutive Officer is a member of the Board of Directors of Satellite. As of December 31, 2009, we hadoutstanding receivables from Satellite of $2.8 million which, in accordance with their terms, were paid to us inJanuary 2010. December 31, 2009 December 31, 2008 Raw materials $1,584 $9 Work in process 1,169 57 Finished goods 6,326 30 Finished goods held by others 336 — Total inventories $9,415 $96 Table of ContentsF. Property, Plant and Equipment Property, plant and equipment consisted of the following at December 31, 2009 and 2008, respectively (in thousands):G. Current and Long-Term LiabilitiesAccrued Expenses Accrued expenses consisted of the following at December 31, 2009 and 2008 (in thousands):Deferred Revenues At December 31, 2009 and 2008, our short-term deferred revenue of $10.2 million and $0.5 million, respectively, related to our sales of Ferahemeunder the Launch Incentive Program and our collaborative agreement with Bayer, respectively. Our long-term deferred revenue of $1.0 million at bothDecember 31, 2009 and 2008, related entirely to our collaborative agreement with 3SBio Inc., or 3SBio. In consideration of the grant of the license to3SBio in 2008, we received an up-front payment of $1 million, the recognition of which has been deferred and is being recognized under theproportional performance methodology as we supply Feraheme to 3SBio over the thirteen year initial term of the agreement.Other Long-Term Liabilities Other long-term liabilities at both December 31, 2009 and 2008 consist solely of deferred rent related to the lease of our principal executive officesin Lexington, Massachusetts.H. Income Taxes For the years ended December 31, 2009 and 2008, we recognized current federal income tax benefits of $1.3 million and $0.3 million, respectively.During 2009, we recognized a $1.1 million tax benefit, which was the result of our recognition of a corresponding $1.1 million income tax expense102 As of December 31, 2009 2008 Land $360 $360 Buildings and improvements 10,356 9,986 Laboratory and production equipment 6,839 5,994 Furniture and fixtures 4,345 3,474 Construction in process 1,294 298 23,194 20,112 Less- accumulated depreciation (10,777) (8,889) Property, plant and equipment, net $12,417 $11,223 December 31, 2009 December 31, 2008 Clinical, manufacturing and regulatoryconsulting fees and expenses $2,134 $1,338 Commercial consulting fees and expenses 3,471 2,752 Salaries, bonuses, and other compensation 8,767 4,989 Professional, license, and other fees andexpenses 1,902 2,492 Commercial rebates, fees and returns 5,657 — Totals $21,931 $11,571 Table of Contentsassociated with the increase in the value of certain securities that we carried at fair market value during the year ended December 31, 2009. This incometax expense was recorded in other comprehensive income. There were no similar income tax benefits or provisions for the years ended December 31,2008 or 2007. In addition, during 2009 and 2008, we recognized $0.2 million and $0.3 million in tax benefits, respectively, associated with U.S.research and development tax credits against which we had previously provided a full valuation allowance, but which became refundable as a result oflegislation passed in each year. The reconciliation of the statutory U.S. federal income tax rate to our effective income tax rate is as follows: Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assetsand liabilities using future enacted rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of thedeferred tax assets will not be realized. The components of our deferred tax assets and liabilities are as follows (in thousands): Due to the uncertainty surrounding the realization of favorable tax attributes in future tax returns, we have recorded a full valuation allowanceagainst our otherwise recognizable net deferred tax assets. The valuation allowance increased by approximately $28.7 million and $32.2 million for theyears ended December 31, 2009 and 2008, respectively, primarily due to an increase in our net operating loss, or NOL, carryforwards, capitalizedresearch and development expense, and equity-based compensation expense. At December 31, 2009, we had federal and state NOL carryforwards of approximately $162.5 million and $110.8 million, respectively, and federalcapital loss carryforwards of $1.3 million to offset future taxable income. We also had an additional $24.4 million and $21.8 million of federal and stateNOLs, respectively, not reflected above which were attributable to deductions from the exercise of103 Years Ended December 31, 2009 2008 2007 Statutory U.S. federal tax rate (34.0)% (34.0)% (34.0)%State taxes, net of federal benefit (2.3)% (5.9)% (6.3)%Permanent items, net 2.1% 2.1% 2.1%Tax credits (1.0)% (2.1)% (1.4)%Valuation allowance 33.9% 39.5% 39.6% Total tax (benefit) expense (1.3)% (0.4)% 0.0% December 31, 2009 2008 Assets Net operating loss carryforwards $61,674 $45,754 Tax credit carryforwards 9,501 8,558 Equity award expense 6,565 3,895 Capitalized research & development 26,225 19,123 Other 9,483 7,188 Liabilities Depreciation (528) (253) 112,920 84,265 Valuation allowance (112,920) (84,265) Net deferred taxes $— $— Table of Contentsequity awards. The benefit from these deductions will be recorded as a credit to additional paid-in capital if and when realized through a reduction oftaxes paid in cash. Our federal NOLs will begin to expire in 2011 and our significant state NOLs expire at various dates through 2015. Our capital losscarryforwards will expire in 2014. In addition, we have federal and state tax credits of approximately $6.9 million and $3.9 million, respectively, tooffset future tax liabilities. Our tax credits will expire periodically through 2030 if not utilized. Utilization of our NOLs and research and development, or R&D, credit carryforwards may be subject to a substantial annual limitation due toownership change limitations that have occurred previously or that could occur in the future in accordance with Section 382 of the Internal RevenueCode of 1986, or Section 382, as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D creditcarryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general an ownership change as defined bySection 382 results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than50 percentage points over a three-year period. Since our formation, we have raised capital through the issuance of capital stock on several occasions.These financings, combined with the purchasing shareholders' subsequent disposition of those shares, may have resulted in a change of control asdefined by Section 382 or could result in a change of control in the future upon subsequent disposition. During 2009, we conducted an analysis underSection 382 to determine if historical changes in ownership through December 31, 2008 would limit or otherwise restrict our ability to utilize theseNOL and R&D credit carryforwards. As a result of this analysis, we do not believe there are any significant limitations on our ability to utilize thesecarryforwards. However, changes in ownership after December 31, 2008 could affect the limitation in future years, including but not limited to our saleof 3,600,000 shares of common stock in January 2010 in connection with an underwritten public offering. If, subsequent to the date of this analysis, wehave experienced a change of control as defined by Section 382, utilization of our NOL or R&D credit carryforwards would be subject to annuallimitation under Section 382, which is determined by first multiplying the value of our stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the NOL orR&D credit carryforwards before utilization. We adopted accounting guidance for uncertainty in income taxes which prescribes a recognition threshold and measurement attribute for thefinancial statement recognition and measurement of a tax position taken or expected to be taken in a tax return and provides guidance on derecognition,classification, interest and penalties, accounting in interim periods, disclosure and transition. At the adoption date of January 1, 2007 and also atDecember 31, 2009, 2008 and 2007, we had no unrecognized tax benefits. We have not, as yet, conducted a study of our R&D credit carryforwards.This study may result in an adjustment to our R&D credit carryforwards; however, until a study is completed and any adjustment is known, no amountsare being presented as an uncertain tax position. A full valuation allowance has been provided against the Company's R&D credits and, if an adjustmentis required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balancesheet or statement of operations if an adjustment were required. We would recognize both accrued interest and penalties related to unrecognized benefits in income tax expense. We have not recorded any interestor penalties on any unrecognized benefits since inception. The statute of limitations for assessment by the Internal Revenue Service, or the IRS, and state tax authorities is closed for tax years prior toSeptember 30, 2006, although carryforward attributes that were generated prior to tax year 2006 may still be adjusted upon examination by the IRS orstate tax authorities if they either have been or will be used in a future period. We file income tax returns in the U.S. federal and various statejurisdictions. There are currently no federal or state audits in progress.104Table of ContentsI. Equity-Based Compensation We maintain several equity compensation plans, including our Amended and Restated 2007 Equity Incentive Plan, or the 2007 Plan, our Amendedand Restated 2000 Stock Plan, or the 2000 Plan, and our 2006 Employee Stock Purchase Plan, or 2006 ESPP.2007 Plan Our 2007 Plan was originally approved by our stockholders in November 2007. In May 2009, our stockholders approved a proposal to amendand restate our 2007 Plan to, among other things, increase the number of shares of our common stock available for issuance thereunder by 600,000shares. The 2007 Plan provides for the grant of stock options, restricted stock units, restricted stock, stock, and other equity interests in our company toemployees, officers, directors, consultants, and advisors of our company and our subsidiaries. The terms and conditions of each such grant, including,but not limited to, the number of shares, the exercise price, term of the option/award and vesting requirements, are determined by our Board ofDirectors, or Board, or the Compensation Committee of our Board. Our Board may award stock options in the form of nonqualified stock options orincentive stock options, or ISOs. ISOs may be granted at an exercise price no less than fair market value of a share of our common stock on the date ofgrant, as determined by our Board or the Compensation Committee of our Board, subject to certain limitations. All stock options granted under the 2007Plan have a contractual term of no greater than ten years. Our Board establishes the vesting schedule for stock options and the method of payment forthe exercise price. In general, options granted vest at a rate of 25 percent on each of the first four anniversaries of the grant date. Our standard stockoption agreement allows for payment of the exercise price for vested stock options either through cash remittance of the exercise price to us in exchangefor newly issued shares, or through a non-cash exchange of previously issued shares held by the recipient equal in value to the exercise price inexchange for newly issued shares. The latter method results in no cash being received by us, but also results in a lower number of total sharessubsequently being outstanding (as compared to a cash exercise), as a direct result of previously issued shares being exchanged in return for theissuance of new shares. Shares returned to us in this manner are retired. We generally issue common stock from previously authorized but unissuedshares to satisfy option exercises and restricted stock awards. In addition, the amendment approved by our stockholders in May 2009 replaced a limitation on the number of shares in the aggregate which couldbe issued under the 2007 Plan with respect to restricted stock units, restricted stock, stock and similar equity interests in our company with a fungibleshare reserve whereby the number of shares available for issuance under the 2007 Plan will now be reduced by one share of our common stock issuedpursuant to an option or stock appreciation right and by 1.5 shares for each share of our common stock issued pursuant to a restricted stock unit awardor other similar equity-based award. As of December 31, 2009, we have granted options and restricted stock units covering 2,114,444 shares of common stock under our 2007 Plan, ofwhich 261,313 stock options and 6,000 restricted stock units have expired or terminated, and of which 11,580 options have been exercised and 1,250shares of common stock were issued pursuant to restricted stock units that became fully vested. The number of options and restricted stock unitsoutstanding under this plan as of December 31, 2009 was 1,632,051 and 202,250, respectively. The remaining number of shares available for futuregrants as of December 31, 2009 was 943,719, not including shares subject to outstanding awards under the 2000 Plan, which will be added to the totalnumber of shares available for issuance under the 2007 Plan to the extent that such awards expire or terminate for any reason prior to exercise. Alloutstanding options granted under our 2007 Plan have an exercise price equal to the closing price of our common stock on the grant date and a ten-yearterm.105Table of Contents2000 Plan Our 2000 Plan provided for the grant of options and other equity-based awards to our directors, officers, employees and consultants. The termsand conditions of each such grant, including, but not limited to, the number of shares, the exercise price, term of the option/award and vestingrequirements, were determined by our Board or the Compensation Committee of our Board. As of December 31, 2009, we have granted options andrestricted stock units covering 2,182,700 shares of common stock under the 2000 Plan, of which 377,800 stock options and 750 restricted stock unitshave expired or terminated, and of which 976,879 stock options have been exercised and 30,000 shares of common stock were issued pursuant torestricted stock units that became fully vested. The remaining number of shares underlying outstanding options and restricted stock units pursuant to the2000 Plan as of December 31, 2009 was 784,021 and 13,250, respectively. All outstanding options granted under the 2000 Plan have an exercise priceequal to the closing price of our common stock on the grant date. In November 2007, the 2000 Plan was succeeded by our 2007 Plan and, accordingly,no further grants may be made under this plan. Any shares that remained available for issuance under the 2000 Plan as of the date of adoption of the2007 Plan are included in the number of shares that may be issued under the 2007 Plan. Any shares subject to outstanding awards granted under the2000 Plan that expire or terminate for any reason prior to exercise will be added to the total number of shares available for issuance under the 2007 Plan.Equity-based compensation expense Equity-based compensation expense, net of amounts remaining capitalized into inventory, was as follows (in thousands): Equity-based compensation expense for the years ended December 31, 2009, 2008 and 2007 included approximately $0.7 million, ($2.1) millionand $2.4 million, respectively, in equity-based compensation expense associated with grants subject to market or performance conditions. Equity-basedcompensation of $0.3 million was capitalized into inventory for the year ended December 31, 2009. Capitalized equity-based compensation isrecognized into cost of product sales when the related product is sold. There were no equity-based compensation costs capitalized in 2008 or priorperiods. Due to the uncertainty surrounding the realization of the favorable tax attributes in future tax returns associated with operating losses we incurredin the past several years, we have not recognized any excess tax benefits from the exercise of options. Accordingly, there was no impact recorded incash flows from financing activities nor cash flows from operating activities as reported in the accompanying consolidated statements of cash flows.106 Years Ended December 31, 2009 2008 2007 Cost of product sales $43 $— $— Research and development 4,446 3,760 1,936 Selling, general and administrative 10,932 4,277 6,246 Total equity-based compensation expense $15,421 $8,037 $8,182 Table of Contents The following table summarizes the weighted average assumptions we utilized for purposes of valuing grants of options to our employees andnon-employee directors: Risk free interest rates utilized are based upon published U.S. Treasury yields at the date of the grant for the expected option term. For stockoptions issued prior to March 31, 2007, we relied exclusively on historical volatility of our own common stock price over the prior period equivalent toour expected option term. For issuances subsequent to March 31, 2007, we estimate our expected stock price volatility by basing it on a blend of thehistorical volatility of our own common stock price and the historical volatility of other similar companies over the prior period equivalent to ourexpected option term to better reflect expected future volatility. For stock options issued prior to March 31, 2007, we used the simplified method aspromulgated by accounting guidance for estimating the expected option term. For stock options issued subsequent to March 31, 2007, we use thecalculated historical term of stock options in computing the expected option term. The following table summarizes details regarding our stock option plans for the year ended December 31, 2009 (excluding restricted stock units,which are presented separately below): The weighted average grant date fair value of stock options granted during the years ended December 31, 2009, 2008 and 2007 were $18.32,$22.61, and $34.77, respectively. The total fair value of options that vested during the years ended December 31, 2009, 2008 and 2007 were$9.6 million, $7.6 million, and $4.2 million, respectively. The aggregate intrinsic value of options exercised in the years ended December 31, 2009,2008 and 2007, excluding purchases made pursuant to our 2003 Employee Stock Purchase Plan, or 2003 ESPP, and our 2006 ESPP, measured as ofthe exercise date, was approximately $9.2 million, $1.6 million, and $17.2 million, respectively. The intrinsic value of a stock option is the amount bywhich the fair market value of the underlying stock exceeds the exercise price of the common stock option.107 Years Ended December 31, 2009 2008 2007 Employees Non-EmployeeDirectors Employees Non-EmployeeDirectors Employees Non-EmployeeDirectors Risk freeinterestrate (%) 2.21 1.70 2.90 1.59 4.41 3.44 Expectedvolatility(%) 60 58 60 59 64 62 Expectedoptionterm(years) 5.40 4.13 5.10 4.70 5.29 5.50 Dividendyield none none none none none none December 31, 2009 Options Weighted AverageExercise Price WeightedAverageRemainingContractualTerm Aggregate IntrinsicValue ($ inmillions) Outstanding at beginning of year 1,991,486 $39.14 Granted 966,898 33.78 Exercised (291,814) 13.87 Expired and/or forfeited (250,498) 43.10 Outstanding at end of year 2,416,072 $39.64 8.1 years $9.9 Outstanding at end of year—vested andunvested expected to vest 2,266,877 $39.66 8.1 years $9.4 Exercisable at end of year 720,677 $40.48 6.7 years $4.2 Table of Contents In the year ended December 31, 2009, we issued an aggregate of 10,000 restricted stock units to employees pursuant to our 2007 Plan. In general,these grants vest ratably, on an annual basis, over a four year period. The estimated fair value of restricted stock units granted was determined at thegrant date based upon the quoted market price per share on the date of the grant. The estimated fair value of restricted stock unit awards issued during2009 was approximately $0.5 million. At December 31, 2009, the amount of unrecorded expense for all outstanding restricted stock units attributable tofuture periods was approximately $5.0 million, and with the exception of the restricted stock awards subject to market conditions, which we expect willvest over an initial derived service period of 2.8 years, is expected to be amortized primarily to expense on a straight line basis over a weighted averageamortization period of approximately 2.4 years. This estimate is subject to change based upon a variety of future events, which include, but are notlimited to, changes in estimated forfeiture rates, achievement of a market condition earlier than expected, and the issuance of new restricted stockawards. The following table summarizes details regarding restricted stock units granted under our equity incentive plans for the year ended December 31,2009: At December 31, 2009, the amount of unrecorded equity-based compensation expense attributable to future periods was approximately$34.7 million, of which $29.7 million was associated with stock options and $5.0 million was associated with restricted stock units. Such amounts willbe amortized, in varying amounts, primarily to research and development or selling, general and administrative expense, generally on a straight line basisover weighted average amortization periods of approximately 2.6 and 2.4 years, respectively. These future estimates are subject to change based upon avariety of future events, which include, but are not limited to, changes in estimated forfeiture rates, and the issuance of new options and other equity-based awards.Employee Stock Purchase Plan Our 2006 ESPP authorizes the issuance of up to 100,000 shares of our common stock to eligible employees. Under the terms of the 2006 ESPP,which began on June 1, 2007 and expires May 31, 2012, eligible employees may purchase shares (subject to certain plan and/or income tax limitations)in ten semi-annual offerings through payroll deductions of up to an annual maximum of 10% of the employee's total compensation, including base payor salary and any overtime, bonuses or commissions. Plan periods consist of six-month periods commencing June 1 and ending November 30 andcommencing December 1 and ending May 31. The purchase price per share is the lesser of 85% of the fair market value of our common stock on thefirst or last day of the plan period. As of December 31, 2009, 2008 and 2007, 56,642, 15,905 and 3,058 shares, respectively, have been issued underour 2006 ESPP.108 December 31, 2009 UnvestedRestrictedStock Units Weighted AverageGrant DateFair Value Outstanding at beginning of year 218,500 $39.62 Granted 10,000 53.10 Vested (12,000) 32.73 Forfeited (1,000) 45.15 Outstanding at end of year 215,500 $40.61 Outstanding at end of year and expected to vest 196,536 $40.61 Table of Contents The assumptions used for awards granted during 2009 under our 2006 ESPP were as follows: The weighted average fair value for purchase rights granted under our 2006 ESPP and our 2003 ESPP during the years ended December 31, 2009,2008 and 2007 was $15.65, $11.83, and $19.23, respectively, and was estimated using the Black-Scholes option-pricing model.Stock Options Granted to Consultants In August 2008, we entered a one-year consulting agreement with a non-employee director. Under the terms of this consulting agreement, thedirector provided consulting and advisory services related to the commercialization and launch of Feraheme. As compensation for these consultingservices, we granted this director, in the aggregate, options to purchase 2,000 shares of our common stock under our 2007 Plan, at an exercise price of$41.57. Such options were fully vested on August 6, 2009. This resulted in a non-cash charge of approximately $28,000 and $10,000 in the yearsended December 31, 2009 and 2008, respectively, with an offsetting credit to additional paid-in capital.J. Employee Savings Plan We provide a 401(k) Plan to our employees by which they may defer compensation for income tax purposes under Section 401(k) of the InternalRevenue Code. Each employee may elect to defer a percentage of his or her salary on a pre-tax basis up to a specified maximum percentage. Our 401(k)Plan provides, among other things, for a company contribution of 3% of each employee's combined base salary and certain other compensation for theplan year. Salary deferred by employees and contributions by us to the 401(k) Plan are not taxable to employees until withdrawn from the 401(k) Planand contributions are deductible by us when made. The amount of our matching contribution for the 401(k) Plan was $1.1 million, $0.6 million, and$0.2 million for the years ended December 31, 2009, 2008 and 2007, respectively.K. Stockholders' EquityPreferred Stock Our certificate of incorporation authorizes our Board to issue preferred stock from time to time in one or more series. The rights, preferences,restrictions, qualifications and limitations of such stock are determined by our Board. On September 4, 2009, our Board adopted a shareholder rightsplan, or Rights Plan. The terms of the Rights Plan provide for a dividend distribution of one Right for each outstanding share of our common stock, parvalue $0.01 per share, to shareholders of record as of September 17, 2009 and for one such Right to attach to each newly issued share of common stockthereafter. Each Right entitles shareholders to purchase one one-thousandth of a share of Series A Junior Participating Preferred Stock for eachoutstanding share of our common stock. The Rights issued pursuant to our Rights Plan become exercisable generally upon the earlier of 10 days after aperson or group, or an Acquiring Person, acquires 20% or more of our outstanding common stock or 10 business days after the announcement by aperson or group of an intention to acquire 20% of our outstanding common stock via tender offer or similar transaction. In that event, each holder of aRight, other than the Acquiring Person, would for a period of 60 days be entitled to purchase, at the exercise price of the Right, such number of sharesof our common stock having a current value of twice the109 Years Ended December 31, 2009 2008 2007 Risk free interest rate (%) 0.21 0.82 4.06 Expected volatility (%) 52 66 33 Expected option term (years) 0.5 0.5 0.5 Dividend yield none none none Table of Contentsexercise price of the Right. Once a person becomes an Acquiring Person, until such Acquiring Person acquires 50% or more of our common stock, ourBoard can exchange the Rights, in part or in whole, for our common stock at an exchange ratio of one share of common stock per Right. If we areacquired in a merger or other business combination transaction, each holder of a Right, other than the Acquiring Person, would then be entitled topurchase, at the exercise price of the Right, such number of shares of the acquiring company's common stock having a current value of twice theexercise price of the Right. The Board may redeem the Rights or terminate the Rights Plan at any time before a person or group becomes an AcquiringPerson. The Rights will expire on September 17, 2019 unless the Rights are earlier redeemed or exchanged by us.Common Stock Transactions In January 2010, we sold 3,600,000 shares of our common stock, $0.01 par value per share, in an underwritten public offering at a price to thepublic of $48.25 per common share, resulting in gross proceeds of approximately $173.7 million. Net proceeds to us after deducting fees, commissionsand other expenses related to the offering were approximately $165.6 million. The shares were issued pursuant to a shelf registration statement onForm S-3 which became effective upon filing.L. Business Segments We have determined that we conduct our operations in one business segment, the research, development and commercialization of products derivedfrom our proprietary technology for use in treating human diseases. Long-lived assets consist entirely of property and equipment and are located in theU.S. for all periods presented.M. Commitments and ContingenciesCommitmentsOperating and Facility Lease Obligations We have entered into certain operating leases, including leases of certain automobiles, and certain laboratory and office equipment which expirethrough 2014. Expense associated with these operating leases for the years ended December 31, 2009, 2008 and 2007, amounted to approximately$0.9 million, $0.5 million, and $0.1 million, respectively. Future minimum lease payments associated with all noncancellable automobile, equipment,service and lease agreements, excluding facility related leases are estimated to be approximately $0.1 million for 2010 and 2011, and less than$0.1 million per year from 2012 through 2014. We lease approximately 110 automobiles for our field-based employees. This lease requires an initialminimum lease term of 12 months per automobile. We expect our monthly expense related to this operating lease to be approximately $60,000. We areresponsible for certain disposal costs in the event of termination of the lease. In May 2008, we entered into a lease agreement for certain real property located at 100 Hayden Avenue, Lexington, Massachusetts for use as ourprincipal executive offices. The term of the lease began on May 22, 2008 and will continue until August 31, 2016 with two successive five yearextension terms at our option. In accordance with accounting guidance related to accounting for operating leases with scheduled rent increases, werecognize rent expense on this facility on a straight line basis over the initial term of the lease. In addition, as provided for under the lease, we receivedapproximately $2.2 million of tenant improvement reimbursements from the landlord. These reimbursements are being recorded as a deferred rentliability in our consolidated balance sheets and are amortized on a straight line basis as a reduction to rent expense over the term of the lease. We haverecorded all tenant improvements as leasehold improvements and are amortizing these improvements over the shorter of the estimated useful life of theimprovement or the remaining life of the initial lease term. Amortization of leasehold improvements is included in depreciation expense.110Table of Contents The lease requires us to pay rent as follows (in thousands): During any extension term, the base rent will be an amount agreed upon by us and the landlord. In addition to base rent, we are also required topay a proportionate share of the landlord's annual operating costs. Facility-related rent expense recorded for the years ended December 31, 2009, 2008 and 2007 was $1.6 million, $1.7 million, and $0.4 million,respectively. In addition, in connection with our facility lease, in May 2008 we delivered to the landlord a security deposit of approximately $0.5 million in theform of an irrevocable letter of credit. The cash securing this letter of credit is classified on our balance sheet as a long-term asset and is restricted in itsuse.Purchase Commitments During 2009 we entered into various agreements with third-parties for which we had remaining purchase commitments of approximately$2.4 million as of December 31, 2009. These agreements principally related to certain outsourced commercial activities such as our field nursing staff,our information technology infrastructure, and other operational activities.Indemnification Obligations As permitted under Delaware law, pursuant to our certificate of incorporation, by-laws and agreements with all of our current directors andexecutive officers, we are obligated to indemnify our officers and directors for certain events or occurrences while the officer or director is, or was,serving at our request in such capacity. The maximum potential amount of future payments we could be required to make under these indemnificationobligations is not capped. We have not incurred costs to defend lawsuits or settle claims related to these indemnification obligations. As a result, webelieve the estimated fair value of these indemnification obligations is immaterial. We are also a party to a number of agreements entered into in the ordinary course of business, which contain typical provisions and which obligateus to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect fromthe date of execution of the applicable agreement for a period equal to the applicable statute of limitations. Our aggregate maximum potential futureliability under such indemnification provisions is uncertain. Since our inception, we have not incurred any expenses as a result of such indemnificationprovisions. Accordingly, we have determined that the estimated aggregate fair value of our potential liabilities under such indemnification provisions isminimal, and we have not recorded any liability related to such indemnification.111Period Minimum LeasePayments Year Ended December 31, 2010 $1,903 Year Ended December 31, 2011 1,959 Year Ended December 31, 2012 2,015 Year Ended December 31, 2013 2,071 Year Ended December 31, 2014 2,127 Thereafter 3,738 Total $13,813 Table of ContentsSeverance Arrangements We have entered into employment agreements with certain executives, which provide for payments to such executives in the event that theexecutive is terminated other than for cause, as defined in the applicable employment agreement.Legal Proceedings We may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities, including claims ordisputes related to patents that have been issued or that are pending in the field of research on which we are focused. We are not aware of any materialclaims against us at December 31, 2009.N. Collaborative Agreements and Contracts Our commercial strategy has included the formation of alliances with other pharmaceutical companies to facilitate the sale and distribution of ourproducts. At present we are parties to the following collaborations:3SBio In 2008, we entered into a Collaboration and Exclusive License Agreement, or the 3SBio License Agreement, and a Supply Agreement, or the3SBio Supply Agreement, with 3SBio with respect to the development and commercialization of Feraheme as an IV iron replacement therapeutic agentin China. The 3SBio License Agreement grants 3SBio an exclusive license for an initial term of thirteen years to develop and commercialize Ferahemeas a therapeutic agent in China for an initial indication for the treatment of IDA in patients with CKD, and an option to expand into additional therapeuticindications. In consideration of the grant of the license, we received an up-front payment of $1 million, the recognition of which has been deferred andis being recognized under the proportional performance methodology as we supply Feraheme to 3SBio over the thirteen year initial term of theagreement. We are eligible to receive certain other specified milestone payments upon regulatory approval of Feraheme in China for CKD and otherindications. We are also entitled to receive tiered royalties of up to 25% based on sales of Feraheme by 3SBio in China. We retained all manufacturingrights for Feraheme. In addition, pursuant to the 3SBio Supply Agreement, 3SBio has agreed to purchase from us, and we have agreed to supply to3SBio, Feraheme at a predetermined supply price for clinical and commercial use in connection with 3SBio's development and commercializationobligations described above for so long as the 3SBio License Agreement is in effect. To date we have not provided 3SBio with any product under thisagreement.Bayer In 1995 we entered into a License and Marketing Agreement and a Supply Agreement, or the Bayer Agreements, with Bayer, granting Bayer aproduct license and exclusive marketing rights to Feridex I.V. in the U.S. and Canada. In connection with our decision to cease manufacturingFeridex I.V., the Bayer Agreements were terminated in November 2008 by mutual agreement. Pursuant to the termination agreement, Bayer couldcontinue to sell any remaining Feridex I.V. inventory in its possession through April 1, 2009 and other than royalties owed by Bayer to us on suchsales, no further obligation exists by either party. As a result of the termination of these agreements, during 2009 we recognized $0.5 million of deferredrevenues, which remained at December 31, 2008.Guerbet In 1989, we entered into a supply and distribution agreement with Guerbet S.A., or Guerbet, granting Guerbet an exclusive right to manufactureand sell GastroMARK in western Europe and Brazil112Table of Contents(under the tradename Lumirem®) and the option to acquire such rights to any future MRI contrast agents developed by us. This agreement wasamended in 2002 to expand Guerbet's exclusive rights to manufacture and sell GastroMARK in various other areas, including South America, theMiddle East, southeast Asia, and eastern Europe. In 2004, it was determined through binding arbitration that Guerbet failed to meet its contractualobligations with respect to the exercise of its option to acquire certain rights to Feraheme in imaging, and, accordingly, all such rights reverted back tous. Under the terms of this distribution agreement, Guerbet has agreed to pay us, as the purchase price for the active ingredient of the licensed products,royalties and a percentage of net sales of the licensed products. We are required to sell to Guerbet its requirements for the active ingredient used inGastroMARK. The agreement is perpetual but terminable upon certain specified events.Covidien In 1990, we entered into a manufacturing and distribution agreement with the predecessor of Covidien Ltd., or Covidien, granting it a productlicense and co-marketing rights to GastroMARK in the U.S., Canada and Mexico. Covidien currently has rights to GastroMARK in the U.S. only.Under the terms of the agreement, we receive royalties based on GastroMARK sales by Covidien as well as a percentage of sales for supplying theactive ingredient. The agreement is perpetual but terminable upon certain specified events.O. Subsequent Events In January 2010, we sold 3,600,000 shares of our common stock, $0.01 par value per share, in an underwritten public offering at a price to thepublic of $48.25 per common share, resulting in gross proceeds of approximately $173.7 million. Net proceeds to us after deducting fees, commissionsand other expenses related to the offering were approximately $165.6 million. The shares were issued pursuant to a shelf registration statement onForm S-3 which became effective upon filing.113Table of ContentsP. Consolidated Quarterly Financial Data—Unaudited The following tables provide consolidated quarterly financial data for the years ended December 31, 2009 and 2008 (in thousands, except per sharedata): Quarterly loss per share totals differ from annual loss per share totals due to rounding. (a) On June 30, 2009, Feraheme was approved for marketing in the U.S. by the FDA for use as an IV iron replacement therapy for the treatmentof IDA in adult patients with CKD. We began shipping Feraheme to our customers in July 2009. (b) In the fourth quarter of 2008 we reversed approximately $4.9 million of compensation expense related to certain performance-based stockoptions which included amounts recorded in 2007 as well as amounts recorded through the first three quarters of 2008. (c) Tax benefit which was the result of our recognition of a corresponding income tax expense recorded in other comprehensive income, March 31, 2009 June 30, 2009 September 30, 2009 December 31, 2009 Product sales, net(a) $393 $— $3,009 $13,080 License fees 516 — — — Royalties 47 55 12 66 Total revenues 956 55 3,021 13,146 Cost of productsales(a) 61 — 128 824 Operating expenses 28,822 27,382 25,460 32,438 Interest and dividendincome, net 1,256 783 503 612 Gains (losses) oninvestments, net 992 275 (319) (6) Fair value adjustmentof settlement rights (923) (185) 321 9 Income tax benefit 179 — — 1,089(c) Net loss $(26,423)$(26,454)$(22,062)$(18,412) Net loss per share—basic and diluted $(1.55)$(1.55)$(1.29)$(1.07) March 31, 2008 June 30, 2008 September 30, 2008 December 31, 2008 Product sales, net $392 $212 $24 $123 License fees 184 185 184 406 Royalties 36 89 52 51 Total revenues 612 486 260 580 Cost of product sales 44 31 3 214 Operating expenses 13,208 19,672 24,812 23,560(b) Interest and dividendincome, net 3,266 2,199 2,021 1,653 Gains (losses) oninvestments, net 73 11 (1,321) (1,787) Fair value adjustmentof settlement rights — — — 1,566 Income tax benefit — — 278 — Net loss $(9,301)$(17,007)$(23,577)$(21,762) Net loss per share—basic and diluted $(0.55)$(1.00)$(1.39)$(1.28)associated with the increase in the value of certain securities during the year ended December 31, 2009.114Table of ContentsQ. Valuation and Qualifying Accounts (in thousands)R. Recently Issued and Proposed Accounting Pronouncements In January 2010, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2010-6, ImprovingDisclosures About Fair Value Measurements, or ASU 2010-6, which also amends Accounting Standards Codification, or ASC, 820. ASU 2010-6requires additional disclosure related to transfers in and out of Levels 1 and 2 and the activity in Level 3. This guidance requires a reporting entity todisclose separately the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and describe the reasons for thetransfers. In addition, this guidance requires a reporting entity to present separately information about purchases, sales issuances, and settlements in thereconciliation for fair value measurements using significant unobservable inputs (Level 3). This accounting standard is effective for interim and annualreporting periods beginning after December 31, 2009 other than for disclosures about purchases, sales, issuances and settlements in the roll forward ofactivity in Level 3 fair value measurements. Those disclosures will be effective for fiscal years beginning after December 31, 2010 and for interimperiods within those fiscal years. We do not expect the adoption of this amendment to have a significant impact on our consolidated financial statements. In October 2009, the FASB issued ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, or ASU 2009-13. ASU 2009-13 amendsexisting revenue recognition accounting pronouncements that are currently within the scope of FASB ASC Subtopic 605-25 (previously includedwithin Emerging Issues Task Force, or EITF, No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21). The consensus to EITFIssue No. 08-1, Revenue Arrangements with Multiple Deliverables, or EITF 08-1, provides accounting principles and application guidance on whethermultiple deliverables exist, how the arrangement should be separated, and the consideration allocated. This guidance eliminates the requirement toestablish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management's estimate ofthe selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. EITF 00-21 previouslyrequired that the fair value of the undelivered item be the price of the item either sold in a separate transaction between unrelated third parties or the pricecharged for each item when the item is sold separately by the vendor. This was difficult to determine115 Balance atBeginningof Period Additions(a) OtherAdditions(b) DeductionsCharged toReserves Balance atEnd ofPeriod Year ended December 31, 2009: Accounts receivable allowances(c) $— $804 $— $(305)$499 Rebates, fees and returns reserves $— $4,792 $1,119 $(254)$5,657 Year ended December 31, 2008: Accounts receivable allowances(c) $— $— $— $— $— Rebates, fees and returns reserves $— $— $— $— $— Year ended December 31, 2007: Accounts receivable allowances(c) $— $— $— $— $— Rebates, fees and returns reserves $— $— $— $— $— (a)Additions to sales discounts, rebates, fees and returns reserves are recorded as a reduction of revenues. (b)Additions to rebate reserves related to deferred revenues are recorded as a reduction to deferred revenues. (c)We have not recorded an allowance for doubtful accounts in any of the years presented above.Table of Contentswhen the product was not individually sold because of its unique features. Under EITF 00-21, if the fair value of all of the elements in the arrangementwas not determinable, then revenue was deferred until all of the items were delivered or fair value was determined. This new approach is effectiveprospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. We are currentlyevaluating the potential impact of this standard on our consolidated financial statements. In December 2009, the FASB issued ASU No. 2009-16, Accounting for Transfers of Financial Assets, or ASU 2009-16. ASU 2009-16 relates tothe accounting and disclosure requirements related to the servicing and transfer of financial assets. ASU 2009-16 enhances information reported tousers of financial statements by providing greater transparency about transfers of financial assets and an entity's continuing involvement in transferredfinancial assets, including securitization transactions, where entities have continuing exposure to the risks related to transferred financial assets. Iteliminates the concept of a "qualifying special-purpose entity," changes the requirements for de-recognizing financial assets, and requires additionaldisclosures. This amendment is effective for fiscal years beginning after November 15, 2009. We do not expect the adoption of this amendment to havea significant impact on our consolidated financial statements. In December 2009, the FASB issued ASU No. 2009-17, Improvements to Financial Reporting by Enterprises Involved with Variable InterestEntities, or ASU 2009-17. ASU 2009-17 relates to the accounting and disclosure requirements related to the consolidation of variable interest entitiesand changes how a reporting entity determines when an entity that is insufficiently capitalized or is not controlled through voting (or similar rights)should be consolidated. The determination of whether a reporting entity is required to consolidate another entity is based on, among other things, theother entity's purpose and design and the reporting entity's ability to direct the activities of the other entity that most significantly impact the other entity'seconomic performance. The reporting entity will be required to provide additional disclosures about its involvement and will be required to disclose howits involvement with a variable interest entity affects the reporting entity's financial statements. This amendment is effective for fiscal years beginningafter November 15, 2009. Early application is not permitted. We do not expect the adoption of this amendment to have a significant impact on ourconsolidated financial statements.ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE: None.ITEM 9A. CONTROLS AND PROCEDURES: Managements' Evaluation of our Disclosure Controls and Procedures Our principal executive officer and principal financial officer, after evaluating the effectiveness of our "disclosure controls and procedures" (asdefined in the Exchange Act Rule 13a-15(e), or Rule 15d-15(e)), with the participation of our management, have each concluded that, as of the end ofthe period covered by this Annual Report on Form 10-K, our disclosure controls and procedures were effective and were designed to ensure thatinformation we are required to disclose in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, is accumulated andcommunicated to management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisionsregarding required disclosure, and is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. Itshould be noted that any system of controls is designed to provide reasonable, but not absolute, assurances that the system will achieve its stated goalsunder all reasonably foreseeable circumstances. Our principal executive officer and principal financial officer have each concluded that our disclosurecontrols and116Table of Contentsprocedures as of the end of the period covered by this report are effective at a level that provides such reasonable assurances.Management's Annual Report on Internal Control Over Financial Reporting The report of our management on both management's responsibility for financial statements and management's annual report on internal controlover financial reporting is contained in Part II, Item 8 "Financial Statements and Supplementary Data" of this Annual Report on Form 10-K for the yearended December 31, 2009.Changes in Internal Control Over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the fourth quarter of the year ended December 31, 2009that materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.ITEM 9B. OTHER INFORMATION: None.117Table of ContentsPART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE: The information required under this item is incorporated herein by reference to the proposal related to the election of our directors and the sectionentitled "Executive Officers and Compensation" in our definitive proxy statement pursuant to Regulation 14A, to be filed with the SEC not later than120 days after the close of our year ended December 31, 2009.ITEM 11. EXECUTIVE COMPENSATION: The information required under this item is incorporated herein by reference to the section entitled "Executive Officers and Compensation" in ourdefinitive proxy statement pursuant to Regulation 14A, to be filed with the SEC not later than 120 days after the close of our year ended December 31,2009.ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATEDSTOCKHOLDER MATTERS: The information required under this item is incorporated herein by reference to the section entitled "Security Ownership of Certain BeneficialOwners and Management" in our definitive proxy statement pursuant to Regulation 14A, to be filed with the SEC not later than 120 days after the closeof our year ended December 31, 2009.ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE: The information required under this item is incorporated herein by reference to the section entitled "Certain Relationships and RelatedTransactions" and to the proposal related to the election of our directors in our definitive proxy statement pursuant to Regulation 14A, to be filed withthe SEC not later than 120 days after the close of our year ended December 31, 2009.ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES: The information required under this item is incorporated herein by reference to the proposal related to the ratification of appointment of independentauditor in our definitive proxy statement pursuant to Regulation 14A, to be filed with the SEC not later than 120 days after the close of our year endedDecember 31, 2009.118Table of ContentsPART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES: (a)The following documents are filed as part of this Annual Report on Form 10-K: 1.Financial Statements.Management's Annual Report on Internal Control over Financial ReportingReport of Independent Registered Public Accounting FirmConsolidated Balance Sheets—as of December 31, 2009 and 2008Consolidated Statements of Operations—for the years ended December 31, 2009, 2008 and 2007Consolidated Statements of Comprehensive Loss—for the years ended December 31, 2009, 2008 and 2007Consolidated Statements of Stockholders' Equity—for the years ended December 31, 2009, 2008 and 2007Consolidated Statements of Cash Flows—for the years ended December 31, 2009, 2008 and 2007Notes to Consolidated Financial Statements2.Financial Statement Schedules. No financial statement schedules have been submitted because they are not required, notapplicable, or because the information required is included in the financial statements or the notes thereto. 3.Exhibit Index.119ExhibitNumber Description3.1, 4.1 Certificate of Incorporation of the Company, as amended (incorporated herein by reference to Exhibit 3.1 to the Company's QuarterlyReport on Form 10-Q for the quarter ended June 30, 2008, File No. 0-14732).3.2, 4.2 By-Laws of the Company, as amended (incorporated herein by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K filedNovember 28, 2008, File No. 0-14732).3.3, 4.3 Certificate of Designation of Series A Junior Participating Preferred Stock (incorporated herein by reference to Exhibit 3.1 and 4.1 to theCompany's Current Report on Form 8-K filed September 4, 2009, File No. 0-14732).4.4 Specimen certificate representing the Company's Common Stock (incorporated herein by reference to Exhibit 4.3 to the Quarterly Report onForm 10-Q for the quarter ended September 30, 2009, File No. 0-14732).4.5 Rights Agreement dated as of September 4, 2009 by and among AMAG Pharmaceuticals, Inc. and American Stock Transfer & TrustCompany, LLC (incorporated herein by reference to Exhibit 4.2 to the Company's Current Report on Form 8-K filed September 4, 2009,File No. 0-14732).4.6 Form of Right Certificate (incorporated herein by reference to Exhibit 4.3 to the Company's Current Report on Form 8-K filed September 4,2009, File No. 0-14732).10.1* Advanced Magnetics, Inc. Amended and Restated 2000 Stock Plan (incorporated herein by reference to Appendix A to the Company'sdefinitive proxy statement for the year ended September 30, 2005, File No. 0-14732).10.2+ Representative Form of Indemnification Agreement.Table of Contents120ExhibitNumber Description10.3* Specimen of Stock Option Grant in connection with 2000 Stock Plan (employees) (incorporated herein by reference to Exhibit 10.1 to theCompany's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, File No. 0-14732).10.4* Specimen of Stock Option Grant in connection with 2000 Stock Plan (non-employees) (incorporated herein by reference to Exhibit 10.2 tothe Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, File No. 0-14732).10.5* Form of Restricted Stock Unit Agreement in connection with the Company's Amended and Restated 2000 Stock Plan (incorporated hereinby reference to Exhibit 10.4 to the Company's Current Report on Form 8-K filed February 13, 2006, File No. 0-14732).10.6* Summary of the Company's Change of Control Policy applicable to executive officers (incorporated herein by reference to Exhibit 10.5 tothe Company's Current Report on Form 8-K filed February 13, 2006, File No. 0-14732).10.7* Advanced Magnetics, Inc. 2006 Employee Stock Purchase Plan (incorporated herein by reference to Exhibit 10.1 to the Company'sQuarterly Report on Form 10-Q for the quarter ended March 31, 2007, File No. 0-14732).10.8* Summary of the Company's Amended and Restated Non-Employee Director Compensation Policy (incorporated herein by reference toExhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, File No. 0-14732).10.14* Second Amended and Restated Employment Agreement dated as of December 15, 2009 between the Company and Brian J.G. Pereira,MD. (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed December 17, 2009, File No. 0-14732).10.15* Form of [Second] Amended and Restated Employment Agreement dated as of December 15, 2009 between the Company and eachexecutive officer of the Company (other than Dr. Pereira) (incorporated herein by reference to Exhibit 10.2 to the Company's CurrentReport on Form 8-K filed December 17, 2009, File No. 0-14732).10.16* AMAG Pharmaceuticals, Inc. Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.3 to theCompany's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, File No. 0-14732.10.17* Form of Option Agreement (ISO) in connection with the Company's 2007 Equity Incentive Plan (incorporated herein by reference toExhibit 10.2 to the Company's Current Report on Form 8-K filed November 30, 2007, File No. 0-14732).10.18* Form of Option Agreement (Nonqualified Option) in connection with the Company's 2007 Equity Incentive Plan (incorporated herein byreference to Exhibit 10.3 to the Company's Current Report on Form 8-K filed November 30, 2007, File No. 0-14732).10.19* Form of Restricted Stock Unit Agreement in connection with the Company's 2007 Equity Incentive Plan (incorporated herein by referenceto Exhibit 10.4 to the Company's Current Report on Form 8-K filed November 30, 2007, File No. 0-14732).10.20* Form of Option Agreement (Nonqualified Option) for Annual Director Grants in connection with the Company's Amended and Restated2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for thequarter ended March 31, 2009, File No. 0-14732).10.21 Lease Agreement, dated as of May 27, 2008, by and between AMAG Pharmaceuticals, Inc. and Mortimer B. Zuckerman and Edward H.Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 (incorporated herein by reference toExhibit 10.1 to the Company's Current Report on Form 8-K filed May 29, 2008, File No. 0-14732).Table of Contents121ExhibitNumber Description10.22 Collaboration and Exclusive License Agreement between the Company and 3SBio Inc., dated as of May 25, 2008 (incorporated herein byreference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, File No. 0-14732)(confidential treatment previously granted).10.23 Supply Agreement between the Company and 3SBio Inc., dated as of May 25, 2008 (incorporated herein by reference to Exhibit 10.1 to theCompany's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, File No. 0-14732) (confidential treatment previouslygranted).10.24 Commercial Outsourcing Services Agreement, dated October 2008, by and between the Company and Integrated CommercializationServices, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed June 30, 2009, FileNo. 0-14732). (confidential treatment previously granted).10.25 Commercial Packaging Services Agreement, dated May 29, 2009, by and between the Company and Catalent Pharma Solutions LLC.(incorporated herein by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K filed June 30, 2009, File No. 0-14732).(confidential treatment previously granted).21.1+ Subsidiaries of the Company.23.1+ Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.31.1+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of2002.31.2+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of2002.32.1++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.32.2++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.+Exhibits marked with a plus sign ("+") are filed herewith. ++Exhibits marked with a double plus sign ("++") are furnished herewith. *Exhibits marked with a single asterisk reference management contracts, compensatory plans or arrangements, filed in response to Item 15(a)(3)of the instructions to Form 10-K.The other exhibits listed have previously been filed with the SEC and are incorporated herein by reference, as indicated.(b)Exhibits. We hereby file or furnish as exhibits, as the case may be, to this Form 10-K those exhibits listed in Part IV, Item 15(a)(3) above. (c)Financial Statement Schedules. No financial statement schedules have been submitted because they are not required, not applicable, or becausethe information required is included in the financial statements or the notes thereto.Table of ContentsSIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signedon its behalf by the undersigned, thereunto duly authorized. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of theregistrant and in the capacities and on the dates indicated.122 AMAG PHARMACEUTICALS, INC. By: /s/ BRIAN J.G. PEREIRABrian J.G. Pereira,Chief Executive Officer,President and Director Date: February 26, 2010Name Title Date/s/ BRIAN J. G. PEREIRABrian J. G. Pereira, MD Chief Executive Officer and President(Principal Executive Officer) February 26, 2010/s/ DAVID A. ARKOWITZDavid A. Arkowitz Executive Vice President,Chief Financial Officer andChief Business Officer(Principal Financial and Accounting Officer) February 26, 2010/s/ JOSEPH V. BONVENTRE, MD, PHDJoseph V. Bonventre, MD, PhD Director February 26, 2010/s/ MICHAEL NARACHIMichael Narachi Director February 26, 2010/s/ ROBERT J. PEREZRobert J. Perez Director February 26, 2010/s/ LESLEY RUSSELL, MB. CH.B., MRCPLesley Russell, MB. Ch.B., MRCP Director February 26, 2010/s/ DAVEY S. SCOONDavey S. Scoon /s/ RON ZWANZIGERRon Zwanziger Director February 26, 2010Table of Contents123Exhibit Number Description 3.1, 4.1 Certificate of Incorporation of the Company, as amended (incorporated herein by reference to Exhibit 3.1 to the Company's QuarterlyReport on Form 10-Q for the quarter ended June 30, 2008, File No. 0-14732). 3.2, 4.2 By-Laws of the Company, as amended (incorporated herein by reference to Exhibit 3.1 to the Company's Current Report on Form 8-Kfiled November 28, 2008, File No. 0-14732). 3.3, 4.3 Certificate of Designation of Series A Junior Participating Preferred Stock (incorporated herein by reference to Exhibit 3.1 and 4.1 tothe Company's Current Report on Form 8-K filed September 4, 2009, File No. 0-14732). 4.4 Specimen certificate representing the Company's Common Stock (incorporated herein by reference to Exhibit 4.3 to the Current Reporton Form 8-K filed September 4, 2009, File No. 0-14732). 4.5 Rights Agreement dated as of September 4, 2009 by and among AMAG Pharmaceuticals, Inc. and American Stock Transfer & TrustCompany, LLC (incorporated herein by reference to Exhibit 4.2 to the Company's Current Report on Form 8-K filed September 4,2009, File No. 0-14732). 4.6 Form of Rights Certificate (incorporated herein by reference to Exhibit 4.3 to the Company's Current Report on Form 8-K filedSeptember 4, 2009, File No. 0-14732). 10.1* Advanced Magnetics, Inc. Amended and Restated 2000 Stock Plan (incorporated herein by reference to Appendix A to the Company'sdefinitive proxy statement for the year ended September 30, 2005, File No. 0-14732). 10.2+ Representative Form of Indemnification Agreement. 10.3* Specimen of Stock Option Grant in connection with 2000 Stock Plan (employees) (incorporated herein by reference to Exhibit 10.1 tothe Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, File No. 0-14732). 10.4* Specimen of Stock Option Grant in connection with 2000 Stock Plan (non-employees) (incorporated herein by reference toExhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, File No. 0-14732). 10.5* Form of Restricted Stock Unit Agreement in connection with the Company's Amended and Restated 2000 Stock Plan (incorporatedherein by reference to Exhibit 10.4 to the Company's Current Report on Form 8-K filed February 13, 2006, File No. 0-14732). 10.6* Summary of the Company's Change of Control Policy applicable to executive officers (incorporated herein by reference to Exhibit 10.5to the Company's Current Report on Form 8-K filed February 13, 2006, File No. 0-14732). 10.7* Advanced Magnetics, Inc. 2006 Employee Stock Purchase Plan (incorporated herein by reference to Exhibit 10.1 to the Company'sQuarterly Report on Form 10-Q for the quarter ended March 31, 2007, File No. 0-14732). 10.8* Summary of the Company's Amended and Restated Non-Employee Director Compensation Policy (incorporated herein by reference toExhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, File No. 0-14732). 10.14* Second Amended and Restated Employment Agreement dated as of December 15, 2009 between the Company and Brian J.G. Pereira,MD. (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed December 17, 2009, FileNo. 0-14732). 10.15* Form of [Second] Amended and Restated Employment Agreement dated as of December 15, 2009 between the Company and eachexecutive officer of the Company (other than Dr. Pereira) (incorporated herein by reference to Exhibit 10.2 to the Company's CurrentReport on Form 8-K filed December 17, 2009, File No. 0-14732). 10.16* AMAG Pharmaceuticals, Inc. Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.3 tothe Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, File No. 0-14732).Table of Contents124Exhibit Number Description 10.17* Form of Option Agreement (ISO) in connection with the Company's 2007 Equity Incentive Plan (incorporated herein by reference toExhibit 10.2 to the Company's Current Report on Form 8-K filed November 30, 2007, File No. 0-14732). 10.18* Form of Option Agreement (Nonqualified Option) in connection with the Company's 2007 Equity Incentive Plan (incorporated hereinby reference to Exhibit 10.3 to the Company's Current Report on Form 8-K filed November 30, 2007, File No. 0-14732). 10.19* Form of Restricted Stock Unit Agreement in connection with the Company's 2007 Equity Incentive Plan (incorporated herein byreference to Exhibit 10.4 to the Company's Current Report on Form 8-K filed November 30, 2007, File No. 0-14732). 10.20* Form of Option Agreement (Nonqualified Option) for Annual Director Grants in connection with the Company's Amended andRestated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, File No. 0-14732). 10.21 Lease Agreement, dated as of May 27, 2008, by and between AMAG Pharmaceuticals, Inc. and Mortimer B. Zuckerman and EdwardH. Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 (incorporated herein by reference toExhibit 10.1 to the Company's Current Report on Form 8-K filed May 29, 2008, File No. 0-14732). 10.22 Collaboration and Exclusive License Agreement between the Company and 3SBio Inc., dated as of May 25, 2008 (incorporated hereinby reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, File No. 0-14732)(confidential treatment previously granted). 10.23 Supply Agreement between the Company and 3SBio Inc., dated as of May 25, 2008 (incorporated herein by reference to Exhibit 10.1to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, File No. 0-14732) (confidential treatmentpreviously granted). 10.24 Commercial Outsourcing Services Agreement, dated October 2008, by and between the Company and Integrated CommercializationServices, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed June 30, 2009, FileNo. 0-14732). (confidential treatment previously granted). 10.25 Commercial Packaging Services Agreement, dated May 29, 2009, by and between the Company and Catalent Pharma Solutions LLC.(incorporated herein by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K filed June 30, 2009, File No. 0-14732). (confidential treatment previously granted). 21.1+ Subsidiaries of the Company. 23.1+ Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm. 31.1+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-OxleyAct of 2002. 31.2+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-OxleyAct of 2002. 32.1++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.+Exhibits marked with a plus sign ("+") are filed herewith. ++Exhibits marked with a double plus sign ("++") are furnished herewith. *Exhibits marked with a single asterisk reference management contracts, compensatory plans or arrangements, filed in response to Item 15(a)(3)of the instructions to Form 10-K. The other exhibits listed have previously been filed with the SEC and are incorporated herein by reference, as indicated.Exhibit 10.2 INDEMNIFICATION AGREEMENT This Indemnification Agreement (the “Agreement”) dated as of , 200 , by and between AMAG Pharmaceuticals, Inc., a DelawareCorporation (the “Company”); and , a director and/or officer of the Company (the “Indemnitee”): WITNESSETH: WHEREAS, the Indemnitee is presently serving as a director and/or officer of the Company, and the Company desires the Indemnitee to continue insuch capacity; WHEREAS, the Company and the Indemnitee recognize the substantial increase in corporate litigation in general as well as the adoption of recentlyimplemented corporate governance legislation, subjecting officers and directors to expensive litigation risks, including, in certain circumstances, expenses ofdefending a claim regardless of its merit; WHEREAS, the Company desires to attract and retain the services of highly qualified individuals, such as the Indemnitee, to serve as officers anddirectors of the Company and to indemnify its officers and directors so as to provide them with the maximum protection permitted by law; WHEREAS, in view of these considerations, the Company desires to provide, independent from the indemnification to which the Indemnitee isotherwise entitled by law and under the Company’s certificate of incorporation and by-laws (the “Charter Documents”), indemnification to the Indemnitee andadvances of expenses, all as set forth in this Agreement to the maximum extent permitted by law; NOW, THEREFORE, to induce the Indemnitee to continue to serve in the Indemnitee’s present capacity, to provide greater certainty as to theIndemnitee’s rights and obligations, and in consideration of the premises and the mutual agreements set forth in this Agreement, the Company and theIndemnitee agree as follows: 1. Continued Service. The Indemnitee agrees to continue to serve as a director and/or officer of the Company at the Company’s will (orunder separate agreement, if such agreement exists), in the capacity that the Indemnitee currently serves, for so long as the Indemnitee is duly elected orappointed and qualified in accordance with the Charter Documents or until the Indemnitee resigns in writing in accordance with applicable law or theIndemnitee’s employment agreement with the Company, if the same exists, expires without extension or renewal or is terminated; provided, however, that thisAgreement shall not create any obligation on the part of the Company to retain the Indemnitee in any such position or at any particular compensation. 2. Initial Indemnity. (a) Third Party Proceedings. The Company shall indemnify the Indemnitee, to the  fullest extent permitted by law, if the Indemnitee is a party or is threatened to be made a party to or is otherwise involved in (including, without limitation, as awitness) any threatened, pending or completed action, suit, arbitration, or other alternate dispute resolution mechanism, or investigation, inquiry,administrative hearing or any other actual, threatened or completed proceeding, whether civil, administrative, investigative or criminal including, withoutlimitation, any appeal therefrom (collectively, “Proceeding”) (other than an action by or in the right of the Company), by reason of (or arising in part out of)any event or occurrence related to the fact that the Indemnitee is or was or had agreed to become a director, officer, employee and/or agent of the Company, or isor was serving or had agreed to serve at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture,trust or other enterprise (collectively, “Corporate Status”), or by reason of any action alleged to have been taken or omitted in such capacity, against allExpenses (as defined below), judgments, fines, penalties and amounts paid in settlement (whether with or without court approval), including withoutlimitation all interest, assessments and other charges paid or payable in connection with or in respect of the foregoing, actually and reasonably incurred by theIndemnitee or on the Indemnitee’s behalf in connection with such Proceeding or any claim, issue or matter therein, provided the Indemnitee acted in good faithand in a manner the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action orproceeding, had no reasonable cause to believe the Indemnitee’s conduct was unlawful. The termination of any Proceeding by judgment, order, settlement(whether with or without court approval), conviction, or upon a plea of nolo contendre or its equivalent shall not, of itself, create a presumption that theIndemnitee did not satisfy the foregoing standard of conduct to the extent applicable thereto. As used herein, “Expenses” shall mean all reasonable attorneys’fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges,postage, delivery service fees, and all other disbursements or expenses of the types customarily incurred in connection with prosecuting, defending, preparingto prosecute or defend, investigating, being or preparing to be a witness in, or otherwise participating in a Proceeding, and any federal, state, local or foreigntaxes imposed on the Indemnitee as a result of the actual or deemed receipt of any payments under this Agreement. (b) Proceedings by or in the Right of the Company. The Company shall indemnify the Indemnitee, to the fullest extent permitted by law if, byreason of the Indemnitee’s Corporate Status, or by reason of any action alleged to have been taken or omitted on the part of the Indemnitee while serving in suchcapacity, the Indemnitee was or is a party or is threatened to be made a party to any threatened, pending or completed Proceeding brought in the name or rightof the Company to procure a judgment in its favor against all Expenses, and to the fullest extent permitted by law, amounts paid in settlement, includingwithout limitation all interest, assessments and other charges paid or payable in connection with or in respect of the foregoing, actually and reasonablyincurred by the Indemnitee in connection with such Proceeding or any claim, issue or matter therein, provided the Indemnitee acted in good faith and in amanner the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, except that no indemnification shall be made in respectof (i) any Proceeding, claim, issue or matter as to which the Indemnitee shall have been finally adjudicated by court order or judgment to be liable to theCompany, unless and only to the extent that the Delaware Court of Chancery or any other court in which such Proceeding was brought shall determine uponapplication that, 2 despite the adjudication of liability but in view of all the circumstances of the case, the Indemnitee is fairly and reasonably entitled to indemnity for suchreasonable Expenses which the Court of Chancery or such other court shall deem proper; and (ii) any Proceeding, claim, issue or matter in respect of whichsuch indemnification is expressly prohibited by applicable law. (c) Mandatory Payment of Expenses. Notwithstanding any other provision of this Agreement, to the extent that the Indemnitee has beensuccessful on the merits or otherwise, in defense of any Proceeding referred to in Sections 2(a) or 2(b) hereof or in defense of any claim, issue or matter therein,the Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by the Indemnitee in connection therewith. For purposes of thisSection 2 and without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemedto be a successful result as to such claim, issue or matter. If the Indemnitee is not wholly successful in defense of such Proceeding but is successful, on themerits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify the Indemnitee against allExpenses actually and reasonably incurred by the Indemnitee or on the Indemnitee’s behalf in connection with each successfully resolved claim, issue ormatter. (d) Determination of Indemnification. Any indemnification under Sections 2(a) or 2(b) hereof (unless ordered by a court) shall be made by theCompany upon a determination in accordance with Section 3 hereof or any applicable provision of the Charter Documents, other agreement, resolution orotherwise. Such determination shall be made (i) by the Board of Directors of the Company (the “Board”) by a majority vote of a quorum consisting ofdirectors who were not parties to such Proceeding, (ii) if such a quorum of disinterested directors is not available or so directs, by independent legal counsel(designated in the manner provided below in this subsection (d)) or (iii) by the stockholders of the Company (the “Stockholders”). Independent legal counselshall be designated by vote of a majority of the disinterested directors; provided, however, that if the Board is unable or fails to so designate, such designationshall be made by the Indemnitee subject to the approval of the Company (which approval shall not be unreasonably withheld). The Company agrees to paythe reasonable fees and expenses of such independent legal counsel and to indemnify fully such counsel against costs, charges and expenses (includingattorneys’ and others’ fees and expenses) actually and reasonably incurred by such counsel in connection with this Agreement or the opinion of such counselpursuant hereto. (e) Advancement of Expenses. All Expenses incurred by the Indemnitee in the Indemnitee’s capacity as a director or officer of the Company inconnection with any Proceeding referenced in Section 2(a) or 2(b) hereof (including, without limitation, retainers and prepaid, deposited or escrowed amounts),shall be paid by the Company, as incurred, in advance of the final disposition of such Proceeding in the manner prescribed by Section 3(b) hereof. (f) Company Amendments. The Company shall not adopt any amendment to the Certificate or By-Laws, the effect of which would be todeny, diminish or encumber the Indemnitee’s rights to indemnity pursuant to this Agreement, the Charter Documents, the General Corporation Law of the Stateof Delaware (the “GCL”) or any other applicable law as applied to any act or failure to act occurring in whole or in part prior to the date (the “Effective 3 Date”) upon which the amendment was approved by the Board or the Stockholders, as the case may be. In the event that the Company shall adopt anyamendment to the Certificate or By-Laws, the effect of which is to so deny, diminish or encumber the Indemnitee’s rights to indemnity, such amendment shallapply only to acts or failures to act occurring entirely after the Effective Date thereof unless the Indemnitee shall have voted in favor of such adoption as adirector or holder of record of the Company’s voting stock, as the case may be. (g) Security. To the extent requested by the Indemnitee and approved by the Board, the Company may at any time and from time to timeprovide security to the Indemnitee for the Company’s obligations hereunder through an irrevocable bank letter of credit, funded trust or other collateral. Anysuch security, once provided to the Indemnitee, may not be revoked or released without the prior written consent of the Indemnitee. 3. Certain Procedures Relating to Indemnification and Advancement of Expenses. (a) Notice. Except as otherwise permitted or required by the GCL, for purposes of pursuing rights to indemnification under Sections 2(a) or2(b) hereof, as the case may be, the Indemnitee may, but shall not be required to, (i) submit to the Board a statement of request for indemnificationsubstantially in the form of Exhibit 1 attached hereto and made a part hereof (the “Indemnification Statement”) stating that the Indemnitee is entitled toindemnification hereunder; and (ii) present to the Company reasonable evidence of all expenses for which payment is requested. Submission of anIndemnification Statement to the Board shall create a presumption that the Indemnitee is entitled to indemnification under Sections 2(a) or 2(b) hereof, as thecase may be, and the Board shall be deemed to have determined that the Indemnitee is entitled to such indemnification unless within 30 calendar days aftersubmission of the Indemnification Statement the Board shall determine by vote of a majority of the directors at a meeting at which a quorum is present, basedupon clear and convincing evidence (sufficient to rebut the foregoing presumption), and the Indemnitee shall have received notice within such period in writingof such determination, that the Indemnitee is not so entitled to indemnification, which notice shall disclose with particularity the evidence in support of theBoard’s determination. The foregoing notice shall be sworn to by all persons who participated in the determination and voted to deny indemnification. Theprovisions of Section 2(d) and this Section 3(a) are intended to be procedural only and shall not affect the right of the Indemnitee to indemnification under thisAgreement; and any determination by the Board that the Indemnitee is not entitled to indemnification and any failure to make the payments requested in theIndemnification Statement shall be subject to judicial review as provided in Section 6 hereof. (b) For purposes of receiving advancement of expenses pursuant to Section 2(e) hereof, the Indemnitee shall submit to the Board a statement ofrequest for advancement of expenses substantially in the form of Exhibit 2 attached hereto and made a part hereof (the “Undertaking”), stating that (i) theIndemnitee has reasonably incurred or will reasonably incur actual expenses in defending a Proceeding and (ii) the Indemnitee undertakes to repay suchamount if it shall ultimately be determined that the Indemnitee is not entitled to be indemnified by the Company under this Agreement or otherwise. Suchpayments shall be made by the Company within 10 days of receipt by it of such Undertaking. No security shall be required in connection with anyUndertaking and any Undertaking shall be accepted without reference to the 4 Indemnitee’s ability to make repayment. (c) Assumption of Defense and Selection of Counsel. With respect to any Proceeding of which the Company is notified under Section 3(a), theCompany shall be entitled to participate therein at its own expense and/or to assume the defense thereof at its own expense, with legal counsel approved by theIndemnitee, which approval shall not be unreasonably withheld, upon the delivery to the Indemnitee of written notice of its election to do so, in which case theIndemnitee shall provide the Company such information and cooperation as the Company may reasonably require in connection with such defense and asshall be within the Indemnitee’s power to so provide. After delivery of such notice from the Company to the Indemnitee of its intention to assume the defense ofthe Proceeding, the Indemnitee’s approval of Company counsel, and the retention of such counsel by the Company, the Company will not be liable to theIndemnitee under this Agreement for any fees and expenses of counsel subsequently incurred by the Indemnitee with respect to such Proceeding, other than asprovided below. The Indemnitee shall have the right to retain the Indemnitee’s own counsel in connection with such Proceeding, but the fees and expenses ofsuch counsel incurred after such notice, approval and retention shall be at the expense of the Indemnitee, unless (i) the retention of counsel by the Indemniteehas been authorized by the Company, (ii) counsel to the Indemnitee shall have reasonably concluded that there may be a conflict of interest or position on anysignificant issue between the Company and the Indemnitee in the conduct of the defense of such action or (iii) the Company shall not in fact have retainedcounsel to assume the defense of such action, in each of which cases the fees and expenses of counsel for the Indemnitee shall be at the expense of theCompany, except as otherwise expressly provided by this Agreement. The Company shall not be entitled, without the consent of the Indemnitee, to assume thedefense of any claim brought by or in the right of the Company or as to which counsel for the Indemnitee shall have reasonably made the conclusion providedfor in clause (ii) hereof. Notwithstanding the foregoing, the Company shall not be permitted to settle any Proceeding, or any claim, issue or matter therein, onbehalf of the Indemnitee, without the prior written consent of the Indemnitee, unless the Company assumes full and sole responsibility for such settlement andsuch settlement grants the Indemnitee a complete and unqualified release in respect of any potential or resulting liability or the Indemnitee is otherwise fullyindemnified against all such liability. (d) Notice to Insurers. If, at the time of the receipt by the Company of a notice of a Proceeding pursuant to Section 3(a) hereof, the Companyhas director and officer liability insurance in effect, the Company shall give prompt notice of the commencement, or the threat of the commencement, of suchProceeding to the insurers in accordance with the procedures set forth in the respective applicable insurance policies. The Company shall thereafter take allnecessary action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such Proceeding in accordance with the terms ofsuch policies; provided that no such payments by such insurers shall relieve the Company of any liability or obligation which it may have to the Indemniteeexcept as and to the extent expressly provided under this Agreement. 4. Subrogation; Duplication of Payments. (a) In the event of payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights ofrecovery of the Indemnitee, who shall execute 5 all documents required and shall do everything that may be necessary to secure such rights, including the execution of such documents necessary to enable theCompany effectively to bring suit to enforce such rights. (b) The Company shall not be liable under this Agreement to make any payment in connection with any claim made against the Indemnitee tothe extent the Indemnitee has actually received payment (under any insurance policy, the Charter Documents or otherwise) of the amounts otherwise payablehereunder. 5. The Indemnitee’s Right to Enforce Indemnification Provisions; Presumptions and Burden of Proof; Expenses of Enforcement. (a) Enforcement. If a claim for indemnification or advancement of Expenses made to the Company pursuant to Section 3 hereof is not paid infull by the Company within 30 calendar days after a written claim has been received by the Company, the Indemnitee may at any time thereafter bring suitagainst the Company to recover the unpaid amount of the claim. (b) No Presumptions; Burden of Proof. In any action brought under Section 5(a) hereof, it shall be a defense to a claim for indemnificationpursuant to Sections 2(a) or 2(b) hereof (other than an action brought to enforce a claim for Expenses incurred in defending any Proceeding in advance of itsfinal disposition where the Undertaking, if any is required, has been tendered to the Company) that the Indemnitee has not met the standards of conductwhich make it permissible under the GCL for the Company to indemnify the Indemnitee for the amount claimed, but the burden or proving such defense shallbe on the Company. The failure of the Company (including the Board, independent legal counsel or the Stockholders) to have made a determination prior tocommencement of such action that indemnification of the Indemnitee is proper in the circumstances because the Indemnitee has met the applicable standard ofconduct set forth in the GCL shall not be a defense to such Indemnitee’s claim or create a presumption that the Indemnitee has not met the applicable standardof conduct. In the event that a determination shall have been made pursuant to Section 2(d) of this Agreement that the Indemnitee is not entitled toindemnification, any judicial proceeding commenced pursuant to this Section 5 shall be conducted in all respects as a de novo trial, on the merits, and theIndemnitee shall not be prejudiced by reason of that adverse determination. In connection with any determination by the Company (including the Board,independent legal counsel or the Stockholders) or otherwise as to whether the Indemnitee is entitled to indemnification or Expense advances hereunder, theburden of proof shall be on the Company to establish that the Indemnitee is not so entitled, by clear and convincing evidence. For purposes of anydetermination of good faith, the Indemnitee shall be deemed to have acted in good faith if the Indemnitee’s action is based on the records or books of account ofthe Company, including financial statements, or on information supplied to the Indemnitee by the officers of the Company in the course of their duties, or onthe advice of legal counsel for the Company, by an independent certified public accountant or by an appraiser or other expert selected with reasonable care bythe Company. The knowledge and/or actions, or failure to act, of any other director, officer, agent or employee of the Company shall not be imputed to theIndemnitee for purposes of determining the right to indemnification under this Agreement. The provisions of this Section 5(b) shall not be deemed to beexclusive or to limit in any way the other 6 circumstances in which the Indemnitee may be deemed to have met the applicable standard of conduct set forth in this Agreement. (c) It is the intent of the Company that the Indemnitee not be required to incur the expenses associated with the enforcement of the Indemnitee’srights under this Agreement by litigation or other legal action because the cost and expenses thereof would substantially detract from the benefits intended to beextended to the Indemnitee hereunder. Accordingly, if it should appear to the Indemnitee that the Company has failed to comply with any of its obligationsunder this Agreement or in the event that the Company or any other person takes any action to declare this Agreement void or unenforceable, or institutes anyaction, suit or proceeding designed (or having the effect of being designed) to deny, or to recover from, the Indemnitee the benefits intended to be provided to theIndemnitee hereunder, the Company irrevocably authorizes the Indemnitee from time to time to retain counsel of the Indemnitee’s choice, at the expense of theCompany as hereinafter provided, to represent the Indemnitee in connection with the initiation or defense of any litigation or other legal action, whether by oragainst the Company or any director, officer, stockholder or other person affiliated with the Company, in any jurisdiction. Regardless of the outcome thereof,the Company shall pay and be solely responsible for any and all costs, charges and expenses (including attorneys’ and others’ fees and expenses) reasonablyincurred by the Indemnitee (i) as a result of the Company’s failure to perform this Agreement or any provision thereof or (ii) as a result of the Company or anyperson contesting the validity or enforceability of this Agreement or any provision thereof as aforesaid. (d) The Company shall be precluded from asserting in any judicial proceeding commenced pursuant to this Section 5 that the procedures andpresumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court that the Company is bound by all the provisionsof this Agreement. 6. Additional Indemnification Rights. Notwithstanding any other provision of this Agreement, the Company hereby agrees to indemnifythe Indemnitee to the fullest extent permitted by law, notwithstanding that such indemnification is not specifically authorized by the other provisions of thisAgreement, the Company’s Charter Documents or by statute. In the event of any change, after the date of this Agreement, in any applicable law, statute, orrule which expands the right of a Delaware corporation to indemnify a member of its board of directors, an officer, or an agent, such changes shall be, ipsofacto, within the purview of the Indemnitee’s rights and the Company’s obligations under this Agreement. In the event of any change in any applicable law,statute or rule which narrows the right of a Delaware corporation to indemnify a member of its board of directors or an officer, such changes, to the extent nototherwise required by such law, statute or rule to be applied to this Agreement shall have no effect on this Agreement or the parties’ rights and obligationshereunder. 7. Merger or Consolidation. In the event that the Company shall be a constituent corporation in a consolidation, merger or otherreorganization, the Company, if it shall not be the surviving, resulting or other corporation therein, shall require as a condition thereto the surviving, resultingor acquiring corporation to agree to indemnify the Indemnitee to the full extent provided in Section 2 hereof. Whether or not the Company is the resulting,surviving or acquiring corporation in any such transaction, the Indemnitee shall also stand in the same 7 position under this Agreement with respect to the resulting, surviving or acquiring corporation as the Indemnitee would have with respect to the Company if itsseparate existence had continued. 8. Nonexclusivity; Effectiveness; and Severability. (a) The right to indemnification provided by this Agreement shall not be exclusive of any other rights to which the Indemnitee may be entitledunder the Charter Documents, the GCL, any other statute, insurance policy, agreement, vote of stockholders or directors or otherwise, both as to actions takenor omitted in the Indemnitee’s official capacity and as to actions taken or omitted in another capacity while holding such office, and shall continue after theIndemnitee has ceased to be a director, officer, employee or agent and shall inure to the benefit of the Indemnitee’s heirs, executors and administrators. ThisAgreement shall be effective as of the date set forth on the first page and shall apply to acts or omissions of the Indemnitee that occurred prior to, on, and/orafter such date, provided that the Indemnitee was serving in an indemnified capacity at the time such act or omission occurred. (b) If any provision or provisions of this Agreement or the application of any provision hereof to any person or circumstances is held invalid,illegal or otherwise unenforceable, the validity, legality and enforceability of the remaining provisions of this Agreement and the application of such provisionto other persons or circumstances (including, without limitation, each portion of any Section of this Agreement containing any such provision held to beinvalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby, and the provision orprovisions so held to be invalid, illegal or otherwise unenforceable shall be deemed reformed to the extent (and only to the extent) necessary to make it valid,legal and enforceable and to give the maximum effect to the intent of the parties hereto. Without limiting the generality of the foregoing, if this Agreement or anyportion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Company shall nevertheless indemnify the Indemnitee to thefullest extent permitted by any applicable portion of this Agreement that shall not have been invalidated, and the balance of this Agreement not so invalidatedshall be enforceable in accordance with its terms. 9. Partial Indemnification. If the Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for someor a portion of the Expenses, judgments, penalties, fines and amounts paid in settlement (including without limitation all interest, assessments and othercharges paid or payable in connection with or in respect of such Expenses, judgments, penalties, fines and amounts paid in settlement) actually andreasonably incurred by the Indemnitee or on the Indemnitee’s behalf in connection with such Proceeding or any claim, issue or matter therein, but not,however, for the total amount thereof, the Company shall nevertheless indemnify the Indemnitee for the portion to which the Indemnitee is entitled. 10. Exceptions. Any other provision herein to the contrary notwithstanding, the Company shall not be obligated pursuant to the terms of thisAgreement: (a) Claims Initiated by the Indemnitee. To indemnify or advance Expenses to the Indemnitee with respect to any Proceedings initiated orbrought voluntarily by the Indemnitee 8 and not by way of defense, counterclaim or crossclaim, except (i) to the extent not otherwise prohibited by this Agreement, with respect to Proceedings broughtto establish or enforce a right to indemnification under this Agreement or any other agreement or insurance policy or under the Charter Documents or anyapplicable statute or other law, (ii) in specific cases if the Board has approved the initiation or bringing of such Proceeding, or (iii) as otherwise required underSection 145 of the GCL, regardless of whether the Indemnitee ultimately is determined to be entitled to such indemnification, or insurance recovery, as the casemay be; or (b) Lack of Good Faith. To indemnify the Indemnitee with respect to any Proceedings instituted by the Indemnitee to enforce or interpret thisAgreement, if a court of competent jurisdiction determines that each of the material assertions made by the Indemnitee in such Proceeding was not made in goodfaith or was frivolous; or (c) Insured Claims. To indemnify the Indemnitee for Expenses or liabilities of any type whatsoever (including, but not limited to, judgments,fines, penalties, and amounts paid in settlement) to the extent such Expenses or liabilities have been paid directly to the Indemnitee by an insurance carrierunder a policy of insurance; or (d) Claims under Section 16(b). To indemnify the Indemnitee for the payment of profits inuring to and recoverable by the Company pursuantto Section 16(b) of the Securities Exchange Act of 1934, as amended, or any similar successor statute, and any Expenses incurred with respect thereto; or (e) Other Court Determinations. To indemnify the Indemnitee for any acts or omissions, or transactions, from which a court of competentjurisdiction finally determines an officer or director, as applicable, may not be relieved of liability under applicable law or pertinent public policy; or (f) Fraud. To indemnify the Indemnitee if a court of competent jurisdiction finally determines that the Indemnitee has committed fraud on theCompany. 11. Mutual Acknowledgement Regarding Public Policy. Both the Company and the Indemnitee acknowledge that in certain instances,federal law or applicable public policy may prohibit the Company from indemnifying its directors and officers under this Agreement or otherwise. TheIndemnitee understands and acknowledges that the Company has undertaken or may be required in the future to undertake with the Securities and ExchangeCommission (the “SEC”) to submit the question of indemnification to a court in certain circumstances for a determination of the Company’s right underpublic policy to indemnify the Indemnitee. 12. Director and Officer Liability Insurance. In all policies of director and officer liability insurance maintained by the Company (if any),the Indemnitee shall be named as an insured in such a manner as to provide the Indemnitee the same rights and benefits as are accorded to the most favorablyinsured of the Company’s directors, if the Indemnitee is a director of the Company; or of the Company’s officers, if the Indemnitee is not a director of theCompany but is an officer thereof. 9 13. Governing Law. This Agreement and all acts and transactions pursuant hereto and the rights and obligations of the parties hereto shallbe governed by, construed and interpreted in accordance with the laws of the State of Delaware, without giving effect to the principles of conflict of lawsthereof. 14. Consent to Jurisdiction. The Company and the Indemnitee each hereby irrevocably consent to the personal jurisdiction of the Court ofChancery of Delaware for any purpose in connection with any actions or Proceedings that arise out of or relate to this Agreement. 15. Modification; Survival. This Agreement contains the entire agreement and understanding of the parties relating to the subject matterhereof. This Agreement may be modified or amended only by an instrument in writing signed by both parties hereto. No amendment, alteration or repeal ofthis Agreement or of any provision hereof shall limit or restrict any right of the Indemnitee under this Agreement in respect of any action taken or omitted by theIndemnitee in the Indemnitee’s Corporate Status prior to such amendment, alteration or repeal. The failure by either party to enforce any rights under thisAgreement shall not be construed as a waiver of any rights of such party. This Agreement shall survive the death, disability, or incapacity of the Indemnitee orthe termination of the Indemnitee’s service as a director and officer of the Company and shall inure to the benefit of the Indemnitee’s heirs, executors andadministrators. 16. Notices. All notices, request, demands and other communications hereunder shall be in writing and shall be deemed to have been dulygiven (i) upon delivery, if delivered by hand and receipted for by the party to whom said notice or other communication shall have been directed, (ii) on thefirst business day after the date on which it is mailed by overnight courier service or transmitted via facsimile or (iii) on the third business day after the dateon which it is mailed by certified or registered mail with postage prepaid: (i) If to the Indemnitee, at the address specified on the signature page of this Agreement; and (ii) If to the Company to: AMAG Pharmaceuticals, Inc. or to such other address as may have been furnished in writing pursuant to this Section 16 to the Indemnitee by the Company or to the Company by theIndemnitee, as the case may be. 17. Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of whichtogether shall constitute one instrument. 10 18. Company Acknowledgement Regarding Consideration. The Company expressly confirms and agrees that it has entered into thisAgreement and assumed the obligations imposed on it hereby in order to induce the Indemnitee to serve as a director, officer, employee and/or agent of theCompany, and the Company acknowledges that the Indemnitee is relying upon this Agreement in serving in such capacity. 19. Certain Terms. For purposes of this Agreement, references to the “Company” shall include, in addition to AMAG Pharmaceuticals, Inc.,any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger to which AMAG Pharmaceuticals, Inc., (or anyof its subsidiaries) is a party which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers, andemployees or agents, so that if the Indemnitee is or was a director, officer, employee or agent of such constituent corporation, or is or was serving at the requestof such constituent corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, theIndemnitee shall stand in the same position under the provisions of this Agreement with respect to the resulting or surviving corporation as the Indemniteewould have with respect to such constituent corporation if its separate existence had continued; references to “other enterprises” shall include employee benefitplans; references to “fines” shall include any excise taxes assessed on the Indemnitee with respect to any employee benefit plan; and references to “serving atthe request of the Company” shall include any service as a director, officer, employee or agent of the Company which imposes duties on, or involves servicesby, the Indemnitee with respect to an employee benefit plan, its participants or beneficiaries; references to the masculine shall include the feminine; referencesto the singular shall include the plural and vice versa; and if the Indemnitee acted in good faith and in a manner a reasonably believed to be in the interest of theparticipants and beneficiaries of an employee benefit plan, the Indemnitee shall be deemed to have acted in a manner “not opposed to the best interests of theCompany” as referenced to herein. 20. Company Compliance with Law. Nothing in this Agreement is intended to require or shall be construed as requiring the Company todo or fail to do any act in violation of applicable law. The Company’s inability, pursuant to court order, to perform its obligations under this Agreement shallnot constitute a breach of this Agreement. 21. Prior Agreement Terminated. Indemnitee acknowedges that this Agreement supercedes in its entirety any prior IndemnificationAgreement to which the Company and the Indemnitee may be parties. [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] 11 IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the date first above written. AMAG PHARMACEUTICALS, INC. By: Printed Name INDEMNITEE By:Print Name:Address: 12 Exhibit 1 INDEMNIFICATION STATEMENT STATE OF) ) SSCOUNTY OF) I, [NAME], being first duly sworn, do depose and say as follows: 1. This Indemnification Statement is submitted pursuant to the Indemnification Agreement dated as of , 200 between AMAGPHARMACEUTICALS, INC., a Delaware corporation (the “Company”), and the undersigned. 2. I am requesting indemnification against charges, costs, expenses (including attorneys’ and others’ fees and expenses), judgments, finesand amounts paid in settlement, all of which (collectively, “Liabilities”) have been or will be incurred by me in connection with an actual or threatened action,suit, proceeding or claim to which I am a party or am threatened to be made a party. 3. With respect to all matters related to any such action, suit, proceeding or claim, I am entitled to be indemnified as herein contemplatedpursuant to the aforesaid Indemnification Agreement. 4. Without limiting any other rights which I have or may have, I am requesting indemnification against Liabilities which have or may ariseout of 5. Attached is a copy of any and all summons, citations, subpoenas, complaints, indictments and/or other documents that I have received inconnection with the aforementioned action, suit proceeding or claim. Subscribed and sworn to before me, a Notary Public in and for said County and State, this day of , 200 . [Seal] My commission expires the day of 20 . Exhibit 2 UNDERTAKING STATE OF) ) SSCOUNTY OF) I, being first duly sworn, do depose and say as follows: 1. This Undertaking is submitted pursuant to the Indemnification Agreement dated as of , 200 between AMAGPHARMACEUTICALS, INC., a Delaware corporation (the “Company”), and the undersigned. 2. I am requesting advancement of certain costs, charges and expenses which I have incurred or will incur in defending an actual or pendingcivil or criminal action, suit, proceeding or claim. 3. I hereby undertake to repay this advancement of expenses if it shall ultimately be determined that I am not entitled to be indemnified by theCompany under the aforesaid Indemnification Agreement or otherwise. 4. The costs, charges and expenses for which advancement is requested are, in general, all expenses related to . Subscribed and sworn to before me, a Notary Public in and for said County and State, this day of , 200 . [Seal] My commission expires the day of , 20 . Exhibit 21.1 Subsidiaries of AMAG Pharmaceuticals, Inc. Name of SubsidiaryJurisdiction of Formation AMAG Securities CorporationMassachusetts AMAG Europe LimitedUnited Kingdom QuickLinks -- Click here to rapidly navigate through this documentExhibit 23.1 Consent of Independent Registered Public Accounting Firm We hereby consent to the incorporation by reference in the Registration Statement on Form S-3 (File No. 333-164400) and in the RegistrationStatements on Form S-8 (File Nos. 333-82292, 333-131656, 333-143272, 333-148682 and 333-159938) of AMAG Pharmaceuticals, Inc. of ourreport dated February 26, 2010 relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in thisForm 10-K./s/ PRICEWATERHOUSECOOPERS LLPBoston, MassachusettsFebruary 26, 2010 QuickLinksExhibit 23.1QuickLinks -- Click here to rapidly navigate through this documentExhibit 31.1 CERTIFICATIONSI, Brian J.G. Pereira, certify that: 1. I have reviewed this Annual Report on Form 10-K of AMAG Pharmaceuticals, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to makethe statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respectsthe financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as definedin Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared; b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's mostrecent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting,to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internalcontrol over financial reporting.Date: February 26, 2010 /s/ BRIAN J.G. PEREIRABrian J.G. PereiraChief Executive Officer and President(principal executive officer)QuickLinksExhibit 31.1QuickLinks -- Click here to rapidly navigate through this documentExhibit 31.2 CERTIFICATIONSI, David A. Arkowitz, certify that: 1. I have reviewed this Annual Report on Form 10-K of AMAG Pharmaceuticals, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to makethe statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respectsthe financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as definedin Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us byothers within those entities, particularly during the period in which this report is being prepared; b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's mostrecent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonablylikely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting,to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internalcontrol over financial reporting.Date: February 26, 2010 /s/ DAVID A. ARKOWITZDavid A. ArkowitzExecutive Vice President, Chief Financial Officerand Chief Business Officer(principal financial and accounting officer)QuickLinksExhibit 31.2QuickLinks -- Click here to rapidly navigate through this documentExhibit 32.1 CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of AMAG Pharmaceuticals, Inc. (the "Company") on Form 10-K for the period ended December 31, 2009as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Brian J.G. Pereira, Chief Executive Officer and President ofthe Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of myknowledge:(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany. /s/ BRIAN J.G. PEREIRABrian J.G. PereiraChief Executive Officer and President(principal executive officer)Dated: February 26, 2010QuickLinksExhibit 32.1QuickLinks -- Click here to rapidly navigate through this documentExhibit 32.2 CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of AMAG Pharmaceuticals, Inc. (the "Company") on Form 10-K for the period ended December 31, 2009as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, David A. Arkowitz, Executive Vice President, ChiefFinancial Officer and Chief Business Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany. /s/ DAVID A. ARKOWITZDavid A. ArkowitzExecutive Vice President, Chief Financial Officerand Chief Business Officer(principal financial and accounting officer)Dated: February 26, 2010QuickLinksExhibit 32.2

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