(Mark One)
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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the Fiscal Year Ended December 31, 2016
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or
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from to
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Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
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04-2742593
(I.R.S. Employer Identification No.) |
1100 Winter Street
Waltham, Massachusetts
(Address of Principal Executive Offices)
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02451
(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common Stock, par value $0.01 per share
Preferred Share Purchase Rights
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NASDAQ Global Select Market
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Large accelerated filer
x
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Accelerated filer
¨
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Non-accelerated filer
¨
(Do not check if a
smaller reporting company) |
Smaller Reporting Company
¨
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Product or Service
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Uses/Potential Uses
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Regulatory Status
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Nature of Rights to
Product or Service
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Makena
®
(hydroxyprogesterone caproate injection) (5 mL multidose vial)
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A progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.
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Approved and marketed.
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Own worldwide rights.
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Makena
®
(hydroxyprogesterone caproate injection) (1 mL single-dose vial)
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A progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.
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Approved and marketed.
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Own worldwide rights.
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Makena
®
(hydroxyprogesterone caproate injection) (Auto-injector device)
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An auto-injector device for subcutaneous administration of
Makena
(the “Makena auto-injector”).
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Supplemental new drug application (“sNDA”) expected to be filed in the second quarter of 2017.
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Own worldwide rights to drug product; exclusively license rights to auto-injector device from Antares Pharma, Inc. (“Antares”).
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Cord Blood Registry
®
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Services related to the collection, processing and storage of umbilical cord blood and cord tissue units.
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Privately banked umbilical cord blood stem cells and cord tissue are regulated by the FDA in the U.S. (no prior approval needed). Facilities are inspected by the FDA.
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Services are marketed and sold primarily in the U.S. and we have certain commercial agreements in Chili, Mexico and the Dominican Republic.
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Feraheme
®
(ferumoxytol)
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IV iron replacement therapeutic agent for the treatment of iron deficiency anemia (“IDA”) in adult patients with chronic kidney disease (“CKD”).
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Approved and marketed.
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Own worldwide rights.
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Feraheme
®
(ferumoxytol)
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IV iron replacement therapeutic agent for the treatment of patients with a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used.
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sNDA filed December 2012. Complete response letter received January 2014. Phase 3 clinical trial ongoing and sNDA expected to be filed in mid-2017.
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Own worldwide rights.
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MuGard
®
Mucoadhesive Oral Wound Rinse
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Management of oral mucositis/stomatitis and all types of oral wounds.
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Cleared and marketed.
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Exclusively license rights to develop and sell
MuGard
in the U.S. from Abeona Therapeutics, Inc. (“Abeona”).
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Rekynda
TM
(bremelanotide) (Auto-injector device)
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An investigational product designed for on-demand treatment of HSDD in pre-menopausal women.
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New Drug Application (“NDA”) expected to be filed in early 2018.
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Exclusively license rights to research, develop and sell
Rekynda
in North America from Palatin Technologies, Inc. (“Palatin”).
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Digoxin immune fab (
“
DIF
”
)
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A polyclonal antibody for the treatment of severe preeclampsia in pregnant women.
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In clinical development.
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Own option to obtain exclusive license from Velo Bio LLC (“Velo”) to U.S. rights upon completion of Phase 2b/3a development.
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2016
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2015
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Makena
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42
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%
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30
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%
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c17P
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28
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%
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40
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%
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Other therapies or untreated
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30
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%
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30
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%
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•
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Venofer
®
, an iron sucrose complex, which is approved for use in hemodialysis, peritoneal dialysis, non-dialysis dependent CKD patients and pediatric CKD patients and is marketed in the U.S. by Fresenius Medical Care North America and American Regent Laboratories, Inc. (“American Regent”), a subsidiary of Luitpold Pharmaceuticals, Inc. Venofer
®
is typically administered as a slow intravenous injection over two to five minutes in doses of 100 to 200 milligrams, thus requiring five to ten physician visits to reach a standard one gram therapeutic course.
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•
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Injectafer
®
, a ferric carboxymaltose injection, was approved in the U.S. in July 2013 to treat IDA in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron. Injectafer
®
is also indicated for IDA in adult patients with non-dialysis dependent CKD. Injectafer
®
is marketed in the U.S. by American Regent, the same distributor of Venofer
®
. The labeled administration of Injectafer
®
is two slow injections or infusion of 750 milligrams each separated by at least seven days for a total cumulative dose of 1.50grams, or one and a half grams per therapeutic course;
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•
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Ferrlecit
®
, a sodium ferric gluconate, which is marketed by Sanofi-Aventis U.S. LLC, is approved for use only in hemodialysis patients. The recommended dose of Ferrlecit
®
and the generic version of Ferrlecit
®
is 125 milligrams administered by intravenous infusion over one hour per dialysis session or undiluted as a slow intravenous injection per dialysis session, thus requiring eight physician visits to reach a standard one gram therapeutic course;
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•
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A generic version of Ferrlecit
®
marketed by Teva Pharmaceuticals, Inc.; and
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•
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INFeD
®
, an iron dextran product marketed by Allergan, Inc. which is approved in the U.S. for the treatment of patients with documented iron deficiency in whom oral iron administration is unsatisfactory or impossible. The recommended dose of INFeD
®
is a slow push in 100 milligram doses, which would require up to ten physician visits to receive a standard one gram therapeutic course.
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2016 U.S. Non-dialysis
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2015 U.S. Non-dialysis
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IV Iron Market
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IV Iron Market
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(1,114,000 grams)
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(1,000,000 grams)
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Venofer
®
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38
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%
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40
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%
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Injectafer®
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21
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%
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14
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%
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INFeD
®
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15
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%
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18
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%
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Feraheme
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13
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%
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14
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%
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Generic sodium ferric gluconate
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9
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%
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9
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%
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Ferrlecit
®
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4
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%
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5
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%
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Years Ended December 31,
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2016
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2015
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2014
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AmerisourceBergen Drug Corporation
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22
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%
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25
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%
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34
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%
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McKesson Corporation
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11
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%
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11
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%
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21
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%
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Takeda Pharmaceuticals Company Limited
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—
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%
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12
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%
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11
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%
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Cardinal Health, Inc.
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<10
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%
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<10
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%
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15
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%
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•
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The AKS makes it illegal to knowingly and willfully solicit, offer, receive, or pay any remuneration, directly or indirectly, in cash or in kind, in exchange for, or to induce, purchasing, ordering, arranging for, or recommending the purchase or order of any item or service, including the purchase or prescription of a particular drug, that is reimbursed by a federal healthcare program. Liability may be established without proving actual knowledge of the statute or specific intent to violate it. In addition, federal law now provides that the government may assert that a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA, described below. Violations of the AKS carry potentially significant civil and criminal penalties, including imprisonment, fines, and exclusion from participation in federal healthcare programs. Many states have enacted similar anti-kickback laws, including in some cases laws that prohibit paying or receiving remuneration to induce a referral or recommendation of an item or service reimbursed by any payer, including private payers.
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•
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The FCA prohibits, among other things, anyone from knowingly presenting, or causing to be presented, claims for reimbursement of drugs or services to government payers such as Medicare or Medicaid, or other claims for payment of government funds, where those claims are false or fraudulent. The FCA also prohibits knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim or having possession, custody, or control of property or money used, or to be used, by the federal government and knowingly delivering or causing to be delivered, less than all of that money or property. The FCA permits a private individual acting as a “whistleblower” to bring an action on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. Government enforcement agencies and private whistleblowers have asserted liability under the FCA for, among other things, claims for items or services not provided as claimed or for medically unnecessary items or services, kickbacks, promotion of off-label uses, and misreporting of drug prices to federal agencies. Many states have enacted similar false claims laws, including in some cases laws that apply where a claim is submitted to any third-party payer, not just government programs.
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The FCPA prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment.
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Actual or perceived safety or efficacy issues;
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Restrictions on current or future labels or other regulatory actions;
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The introduction or greater acceptance of competing products or services, including generic products, products that may be prescribed off-label (
i.e.
, outside of indications approved by the U.S. Food and Drug Administration (the “FDA”)), products made by compounding pharmacies or cryopreservation services offered by other cord blood banks;
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Change in consumers’ perception of the value of the cryopreservation of cord blood and/or cord tissue;
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Constraints on product or service pricing or the impact of price increases;
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The success of our commercialization efforts, such as our ability to retain or grow our current customer base, realize the benefit of our current orphan drug exclusivity and successfully implement our next generation development programs; and
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Changes in reimbursement policies or adverse regulatory or legislative developments.
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Requiring us to conduct post-approval clinical studies to assess known risks or new signals of serious risks, or to evaluate unexpected serious risks;
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Mandating changes to a product’s label;
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Requiring us to implement a risk evaluation and mitigation strategy (“REMS”) where necessary to assure safe use of the drug; or
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Removing an already approved product from the market.
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Adverse financial developments at or affecting the supplier;
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Unexpected demand for or shortage of raw or other materials;
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Regulatory requirements or action;
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An inability to provide timely scheduling and/or sufficient capacity;
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Manufacturing difficulties;
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Changes to the specifications of the raw materials such that they no longer meet our standards;
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Lack of sufficient quantities or profit on the production of raw materials to interest suppliers;
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Labor disputes or shortages; or
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Import or export problems.
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The possibility that the benefit of the remaining exclusivity period resulting from the designation of
Makena
as an orphan drug may not be realized as a result of on-label or off-label use by physicians of current or future FDA-approved drugs in the market where
Makena
competes;
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The level of enforcement by the FDA to ensure that compounded copies of commercially available FDA-approved products manufactured by compounding pharmacies, including compounded copies of
Makena
that may be in violation of the federal Drug Quality and Security Act (“DQSA”) and other relevant provisions of the FDC Act, are not produced and dispensed to patients;
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The size of the pool of patients who meet the FDA-approved indication for
Makena;
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The actual or perceived safety and efficacy of
Makena
;
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Our ability to increase patient compliance in line with the current label;
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Our ability to gain or maintain insurance coverage for
Makena
for patients through both commercial insurance companies and government programs such as Medicaid, and that such insurance coverage does not create difficulties for physicians or patients to gain access to
Makena
, such as through prior authorizations to non-preferred status on hospital or insurance formularies; and
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Our ability to successfully leverage our commercial organization and distribution networks in marketing, selling and supplying
Makena.
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Our ability to demonstrate to healthcare providers, particularly hematologists, oncologists, hospitals, nephrologists, and others who may purchase or prescribe
Feraheme
, the clinical efficacy and safety of
Feraheme
as an alternative to currently marketed IV iron products which treat IDA in adult CKD patients;
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•
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Our ability to convince physicians and other healthcare providers to use IV iron, and
Feraheme
in particular, rather than oral iron, which is the current treatment of choice of most physicians for treating IDA in adult CKD patients;
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The actual or perceived safety and efficacy profile of
Feraheme
as compared to alternative iron replacement therapeutic agents;
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The relative price and level of reimbursement for
Feraheme
from payers, including government payers, such as Medicare and Medicaid, and private payers as compared to the price and level of reimbursement for alternative IV iron products;
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The actual or perceived convenience and ease of administration of
Feraheme
as compared to alternative iron replacement therapeutic agents, including iron administered orally, in light of recent or potential changes to the methods of
Feraheme
administration;
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Our ability to execute on our contracting strategy and offer competitive discounts, rebates and other incentives, which can result in increasing the rebates we are required to pay under the Medicaid Drug Rebate program and the discounts we are required to offer under the 340B drug pricing program;
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Current and future limitations on the approved indications and patient populations for
Feraheme
;
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The introduction of generic versions of ferumoxytol, which may occur in the near-term given the ANDA submitted to the FDA by Sandoz requesting approval to engage in commercial manufacture, use and sale of a generic version of ferumoxytol; and
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The effectiveness of our commercial organization and distribution networks in marketing, selling and supplying
Feraheme
.
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The FDA may determine that
Rekynda
does not demonstrate safety and efficacy in accordance with regulatory agency standards based on the results of the Phase 3 trial, including the co-primary and secondary endpoints and safety results;
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The FDA may determine that the magnitude of efficacy demonstrated in the
Rekynda
studies does not amount to a clinically meaningful benefit to pre-menopausal women with HSDD and thus that the product cannot be approved despite statically significant efficacy results;
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The FDA could analyze and/or interpret data from pre-clinical testing and clinical trials in different ways than we or Palatin interpret it, such as the calculation of effect size in our Phase 3 studies or the sufficiency of data to determine the timing of onset and the dosing of the product;
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The initiation, conduct or results of the remaining drug interaction, safety pharmacology and other ancillary studies may be delayed or unsuccessful;
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The auto-injector device, supplied by an unaffiliated third party, that we plan to use to administer
Rekynda
may not be adequate or may not be approved by the FDA;
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Palatin's ability to establish, and obtain FDA approval for, a commercially viable manufacturing process for
Rekynda
;
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Adverse medical events reported during the trials, including increases in blood pressure noted in prior clinical trials, could lead to requirements to conduct additional studies;
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The failure of clinical investigational sites and the records kept at such sites, including the clinical trial data, to be in compliance with the FDA’s GCP, including the failure to pass FDA inspections of clinical trial sites; and
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The FDA may change their approval policies or adopt new regulations.
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Perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of
Rekynda
;
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The initiation, conduct or results of safety pharmacology studies and whether the FDA imposes any restrictions on the distribution of
Rekynda
:
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Our ability to increase awareness of HSDD and treatment options, and to engage with and educate health care providers and potential consumers about HSDD and the benefits of
Rekynda
;
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Availability of reimbursement from third-party payers;
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Advantages over alternative treatment therapies, including the tolerability of any side effects and self-administration by auto-injector;
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Our ability to maintain a commercially viable manufacturing process that is compliant with cGMP;
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Palatin and our ability to enforce Palatin's intellectual property rights in and to
Rekynda
to prohibit a third-party from marketing a generic product and our ability to avoid third-party patent interference or intellectual property infringement claims;
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Our ability to hire and maintain an expanded sales force and experienced commercialization personnel to compete in the market; and
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An increase in the occurrence or severity of the most common adverse events (nausea, headaches and flushing) or the occurrence of additional adverse events causing patients to discontinue treatment.
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Warning letters, public warnings and untitled letters;
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Court-ordered seizures or injunctions;
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Civil or criminal penalties, or criminal prosecutions;
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Variation, suspension or withdrawal of regulatory approvals for our products or services;
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Changes to the package insert of our products, such as additional warnings regarding potential side effects or potential limitations on the current dosage and administration;
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Requirements to communicate with physicians and other customers about concerns related to actual or potential safety, efficacy, or other issues involving our products and services;
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Implementation of risk mitigation programs and post-marketing obligations;
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Restrictions on our continued manufacturing, marketing, distribution or sale of our products, or the ability to continue to market our services;
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Temporary or permanent closing of the facilities of our third-party contract manufacturers;
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Interruption of clinical trials;
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For HCT/Ps, including umbilical cord blood stem cells and cord tissue, recalls, destruction orders, or cease manufacturing orders; and
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Refusal by regulators to consider or approve applications for additional indications.
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Make it more difficult for us to satisfy our financial obligations under our current debt obligations, or other indebtedness, as well as our contractual and commercial commitments, and could increase the risk that we may default on our debt obligations;
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Prevent us from raising the funds necessary to repurchase 2023 Senior Notes tendered to us if there is a change of control, which would constitute a default under the indenture governing the 2023 Senior Notes, the Convertible Notes and the 2015 Term Loan Facility;
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Require us to use a substantial portion of our cash flow from operations to pay interest and principal on our current debt obligations or other indebtedness, which would reduce the funds available for working capital, capital expenditures and other general corporate purposes;
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Limit our ability to obtain additional financing for working capital, capital expenditures, acquisitions and other investments or general corporate purposes, which may limit the ability to execute our business strategy;
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Heighten our vulnerability to downturns in our business, our industry or in the general economy, and restrict us from exploiting business opportunities or making acquisitions;
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Place us at a competitive disadvantage compared to those of our competitors that may have proportionately less debt;
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Limit management’s discretion in operating our business;
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Limit our flexibility in planning for, or reacting to, changes in our business, the industry in which we operate or the general economy; and
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Result in higher interest expense if interest rates increase and we have outstanding floating rate borrowings such as our 2015 Term Loan Facility.
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Paying dividends, redeeming subordinated indebtedness or making other restricted payments, including certain investments;
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Incurring or guaranteeing additional indebtedness or issuing preferred stock;
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Creating or incurring liens;
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Consummating a merger;
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Consolidating or selling all or substantially all of our or our subsidiaries’ assets;
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Entering into transactions with affiliates;
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Transferring or selling assets;
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Engaging in businesses other than our current businesses and reasonably related extensions thereof;
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Designating subsidiaries as unrestricted subsidiaries; and
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Allowing to exist certain restrictions on the ability of restricted subsidiaries to pay dividends or make other payments to us.
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•
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Product revenues;
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•
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The loss of a key customer or GPO;
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•
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Costs and liabilities incurred in connection with business development activities or business development transactions into which we may enter;
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•
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Costs associated with the commercialization of our products and services;
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•
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Milestone payments we may be required to pay pursuant to contractual obligations, including the Lumara Health Agreement and the Rekynda License Agreement;
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•
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Tax payments and of principal and interest payments in connection with our debt obligations, including the 2015 Term Loan Facility, the 2023 Notes and our Convertible Notes;
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•
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Costs associated with the manufacture of our products and collection, processing and storage services, including costs of raw and other materials and costs associated with maintaining commercial inventory and qualifying additional manufacturing capacities and alternative suppliers;
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•
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The recognition of deferred tax assets during periods in which we generate taxable income and our ability to preserve our net operating loss carryforwards and other tax assets;
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•
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Costs associated with our ongoing and planned clinical studies of
Feraheme,
including costs associated with pursuing a broader indication of
Feraheme
;
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•
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Costs associated with the ongoing and planned clinical studies of
Makena
in connection with current or future post-approval commitments, and our pursuit of our multi-pronged next generation development programs for
Makena
;
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•
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Costs associated with our obligations under the Rekynda License Agreement;
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•
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Any changes to the mix of our business;
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•
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Costs associated with manufacturing batch failures or inventory write-offs due to out-of-specification release testing or ongoing stability testing that results in a batch no longer meeting specifications;
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•
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Changes in accounting estimates related to reserves on revenue, returns, contingent consideration, impairment of long-lived or intangible assets or other accruals or changes in the timing and availability of government or customer discounts, rebates and incentives; and
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•
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The implementation of new or revised accounting or tax rules or policies.
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•
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The ability of our Board to increase or decrease the size of the Board without stockholder approval;
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•
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Advance notice requirements for the nomination of candidates for election to our Board and for proposals to be brought before our annual meeting of stockholders;
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•
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The authority of our Board to designate the terms of and issue new series of preferred stock without stockholder approval;
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•
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Non-cumulative voting for directors; and
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•
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Limitations on the ability of our stockholders to call special meetings of stockholders.
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ITEM 5.
|
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES:
|
|
High
|
|
Low
|
||||
Year Ended December 31, 2016
|
|
|
|
||||
First quarter
|
$
|
29.65
|
|
|
$
|
20.22
|
|
Second quarter
|
$
|
28.98
|
|
|
$
|
17.92
|
|
Third quarter
|
$
|
29.59
|
|
|
$
|
22.01
|
|
Fourth quarter
|
$
|
36.83
|
|
|
$
|
22.81
|
|
Year Ended December 31, 2015
|
|
|
|
||||
First quarter
|
$
|
59.29
|
|
|
$
|
38.25
|
|
Second quarter
|
$
|
74.21
|
|
|
$
|
50.32
|
|
Third quarter
|
$
|
77.73
|
|
|
$
|
37.73
|
|
Fourth quarter
|
$
|
42.95
|
|
|
$
|
25.26
|
|
Period
|
Total Number
of Shares Purchased (1) |
|
Average Price
Paid Per Share |
|
Total Number of
Shares Purchased as Part of Publicly Announced Plans or Programs (2) |
|
Maximum Number
of Shares (or approximate dollar value) That May Yet Be Purchased Under the Plans or Programs (2) |
|||||
October 1, 2016 through October 31, 2016
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
1,556,420
|
|
November 1, 2016 through November 30, 2016
|
4,026
|
|
|
30.89
|
|
|
—
|
|
|
1,204,819
|
|
|
December 1, 2016 through December 31, 2016
|
6,084
|
|
|
33.87
|
|
|
—
|
|
|
1,149,425
|
|
|
Total
|
10,110
|
|
|
$
|
32.68
|
|
|
—
|
|
|
|
(1)
|
Represents the surrender of shares of our common stock withheld by us to satisfy the minimum tax withholding obligations in connection with the vesting of restricted stock units held by our employees.
|
(2)
|
We did not repurchase any of our common stock during the
fourth
quarter of
2016
. We have repurchased and retired
$20.0 million
of our common stock under our share repurchase program to date. These shares were purchased pursuant to a repurchase program authorized by our board of directors that was announced in January 2016 to repurchase up to $60.0 million of our common stock, of which
$40.0 million
remains outstanding as of
December 31, 2016
. The repurchase program does not have an expiration date and may be suspended for periods or discontinued at any time.
|
|
12/31/2011
|
|
12/31/2012
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
AMAG Pharmaceuticals, Inc.
|
100.00
|
|
77.79
|
|
128.40
|
|
225.38
|
|
159.65
|
|
184.03
|
NASDAQ Biotechnology Index
|
100.00
|
|
132.74
|
|
220.37
|
|
296.19
|
|
331.05
|
|
260.37
|
NASDAQ Global Select Market Index
|
100.00
|
|
115.52
|
|
192.75
|
|
204.34
|
|
204.31
|
|
196.43
|
|
Years Ended December 31,
|
||||||||||||||||||
|
2016
|
|
2015 (1)
|
|
2014 (2)
|
|
2013
|
|
2012
|
||||||||||
|
(in thousands, except per share data)
|
||||||||||||||||||
Statements of Operations Data
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
||||||||||
U.S. product sales, net
|
$
|
432,170
|
|
|
$
|
341,816
|
|
|
$
|
109,998
|
|
|
$
|
71,692
|
|
|
$
|
58,903
|
|
Service revenues, net
|
99,604
|
|
|
24,132
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
License fee, collaboration and other revenues (3)
|
317
|
|
|
52,328
|
|
|
14,386
|
|
|
9,164
|
|
|
26,475
|
|
|||||
Total revenues
|
532,091
|
|
|
418,276
|
|
|
124,384
|
|
|
80,856
|
|
|
85,378
|
|
|||||
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product sales (excluding impairment) (4)
|
96,314
|
|
|
78,509
|
|
|
20,306
|
|
|
11,960
|
|
|
14,220
|
|
|||||
Cost of services
|
20,575
|
|
|
9,992
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Research and development expenses
|
66,084
|
|
|
42,878
|
|
|
24,160
|
|
|
20,564
|
|
|
33,296
|
|
|||||
Selling, general and administrative expenses (5)
|
249,870
|
|
|
160,309
|
|
|
72,254
|
|
|
59,167
|
|
|
53,071
|
|
|||||
Impairment of intangible assets (6)
|
19,663
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Acquisition-related costs
|
—
|
|
|
11,232
|
|
|
9,478
|
|
|
782
|
|
|
—
|
|
|||||
Restructuring expenses
|
715
|
|
|
4,136
|
|
|
2,023
|
|
|
—
|
|
|
2,215
|
|
|||||
Total costs and expenses
|
453,221
|
|
|
307,056
|
|
|
128,221
|
|
|
92,473
|
|
|
102,802
|
|
|||||
Operating income (loss)
|
78,870
|
|
|
111,220
|
|
|
(3,837
|
)
|
|
(11,617
|
)
|
|
(17,424
|
)
|
|||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense (7)
|
(73,153
|
)
|
|
(53,251
|
)
|
|
(14,697
|
)
|
|
—
|
|
|
—
|
|
|||||
Loss on debt extinguishment (7)
|
—
|
|
|
(10,449
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Interest and dividend income, net
|
3,149
|
|
|
1,512
|
|
|
975
|
|
|
1,051
|
|
|
1,286
|
|
|||||
Other income (expense) (7)
|
189
|
|
|
(9,188
|
)
|
|
217
|
|
|
964
|
|
|
(1,466
|
)
|
|||||
Total other income (expense)
|
(69,815
|
)
|
|
(71,376
|
)
|
|
(13,505
|
)
|
|
2,015
|
|
|
(180
|
)
|
|||||
Net income (loss) before income taxes
|
9,055
|
|
|
39,844
|
|
|
(17,342
|
)
|
|
(9,602
|
)
|
|
(17,604
|
)
|
|||||
Income tax expense (benefit) (8)
|
11,538
|
|
|
7,065
|
|
|
(153,159
|
)
|
|
—
|
|
|
(854
|
)
|
|||||
Net income (loss)
|
$
|
(2,483
|
)
|
|
$
|
32,779
|
|
|
$
|
135,817
|
|
|
$
|
(9,602
|
)
|
|
$
|
(16,750
|
)
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
$
|
(0.07
|
)
|
|
$
|
1.04
|
|
|
$
|
6.06
|
|
|
$
|
(0.44
|
)
|
|
$
|
(0.78
|
)
|
Diluted
|
$
|
(0.07
|
)
|
|
$
|
0.93
|
|
|
$
|
5.45
|
|
|
$
|
(0.44
|
)
|
|
$
|
(0.78
|
)
|
Weighted average shares outstanding used to compute net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
34,346
|
|
|
31,471
|
|
|
22,416
|
|
|
21,703
|
|
|
21,392
|
|
|||||
Diluted
|
34,346
|
|
|
35,308
|
|
|
25,225
|
|
|
21,703
|
|
|
21,392
|
|
|
December 31,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and investments
|
$
|
579,086
|
|
|
$
|
466,331
|
|
|
$
|
144,186
|
|
|
$
|
213,789
|
|
|
$
|
227,043
|
|
Working capital (current assets less current liabilities)
|
$
|
405,681
|
|
|
$
|
360,753
|
|
|
$
|
107,548
|
|
|
$
|
211,284
|
|
|
$
|
221,423
|
|
Total assets
|
$
|
2,478,426
|
|
|
$
|
2,476,210
|
|
|
$
|
1,388,933
|
|
|
$
|
265,459
|
|
|
$
|
258,137
|
|
Long-term liabilities
|
$
|
1,231,160
|
|
|
$
|
1,298,025
|
|
|
$
|
762,492
|
|
|
$
|
59,930
|
|
|
$
|
52,383
|
|
Stockholders’ equity
|
$
|
934,389
|
|
|
$
|
932,264
|
|
|
$
|
459,953
|
|
|
$
|
172,408
|
|
|
$
|
172,797
|
|
(1)
|
Includes the results of operations of CBR during the post-acquisition period from August 17, 2015 through December 31, 2015. See Note C, “
Business Combinations,”
to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.
|
(2)
|
Includes the results of operations of Lumara Health during the post-acquisition period from November 12, 2014 through December 31, 2014. See Note C, “
Business Combinations,”
to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.
|
(3)
|
In 2015, we recognized $44.4 million in revenues associated with the amortization of the remaining deferred revenue balance as a result of the termination of a license, development and commercialization agreement (the “Takeda Termination Agreement
”
) with Takeda Pharmaceutical Company Limited (“Takeda
”
) and $6.7 million of additional revenues related to payments made by Takeda upon the final termination date under the terms of the Takeda Termination Agreement.
|
(4)
|
Cost of product sales in 2016, 2015 and 2014 included approximately $77.8 million, $63.3 million and $6.1 million of non-cash expense related to the amortization of the step-up of Lumara Health’s inventories and intangible assets to fair value at the acquisition date, respectively. See Note C, “
Business Combinations,”
and Note H, “
Goodwill and Intangible Assets, Net,”
to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.
|
(5)
|
Reflects a full year recognition of CBR Services selling, general and administrative expenses in 2016 compared to a partial period in 2015 following our August 2015 acquisition of CBR as well as an increase in the
Makena-
related contingent consideration based on the expected timing of the milestone payments.
|
(6)
|
In 2016, we recognized a
$15.7 million
impairment charge related to the impairment of the remaining net intangible asset for the MuGard Rights, impairment of the remaining
$0.2 million
, net, CBR-favorable lease intangible asset and a
$3.7 million
impairment charge related to the CBR trade names and trademarks intangible asset.
|
(7)
|
Includes interest expense associated with our current debt obligations, including the 2023 Senior Notes and the 2015 Term Loan Facility entered into in August 2015, the 2014 Term Loan Facility entered into in November 2014 and repaid in August 2015, and the Convertible Notes entered into in February 2014. In addition, a $10.4 million loss on debt extinguishment is included in 2015 as the result of the early repayment of the 2014 Term Loan Facility. 2015 also includes $9.2 million of other expense associated with the financing of the CBR acquisition.
|
(8)
|
The $153.2 million income tax benefit in 2014 reflects a $132.9 million decrease in our valuation allowance due to taxable temporary differences available as a source of income to realize the benefit of certain of our pre-existing deferred tax assets as a result of the acquisition of Lumara Health. See Note J, “
Income Taxes,”
to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.
|
ITEM 7.
|
MANAGEMENT
’
S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS:
|
1.
|
Revenue Recognition and Related Sales Allowances and Accruals
|
•
|
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.
|
•
|
The milestone consideration received is commensurate with either the level of effort required to achieve the milestone or the enhancement of the value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone;
|
•
|
The milestone is related solely to our past performance; and
|
•
|
The milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement.
|
2.
|
Business Combinations
|
•
|
Probability of successfully completing clinical trials and obtaining regulatory approval;
|
•
|
Market size, market growth projections, and market share;
|
•
|
Estimates regarding the timing of and the expected costs to advance our clinical programs to commercialization;
|
•
|
Estimates of future cash flows from potential product sales; and
|
•
|
A discount rate.
|
3.
|
Valuation of investments
|
4.
|
Equity-Based Compensation
|
5.
|
Income Taxes
|
|
Years Ended December 31,
|
|
2016 to 2015
|
|||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
U.S. product sales, net
|
|
|
|
|
|
|
|
|||||||
Makena
|
$
|
334,050
|
|
|
$
|
251,615
|
|
|
$
|
82,435
|
|
|
33
|
%
|
Feraheme
|
97,058
|
|
|
88,452
|
|
|
8,606
|
|
|
10
|
%
|
|||
MuGard
|
1,062
|
|
|
1,749
|
|
|
(687
|
)
|
|
(39
|
)%
|
|||
Total
|
432,170
|
|
|
341,816
|
|
|
90,354
|
|
|
26
|
%
|
|||
Service revenues, net
|
99,604
|
|
|
24,132
|
|
|
75,472
|
|
|
>100
|
%
|
|||
License fee, collaboration and other revenues
|
317
|
|
|
52,328
|
|
|
(52,011
|
)
|
|
(99
|
)%
|
|||
Total Revenues
|
$
|
532,091
|
|
|
$
|
418,276
|
|
|
$
|
113,815
|
|
|
27
|
%
|
|
Years Ended December 31,
|
||||
|
2016
|
|
2015
|
||
AmerisourceBergen Drug Corporation
|
22
|
%
|
|
25
|
%
|
McKesson Corporation
|
11
|
%
|
|
11
|
%
|
Takeda Pharmaceuticals Company Limited
|
—
|
%
|
|
12
|
%
|
|
Years Ended December 31,
|
|
2016 to 2015
|
|||||||||||||||||
|
2016
|
|
Percent of
gross U.S. product sales |
|
2015
|
|
Percent of
gross U.S. product sales |
|
$ Change
|
|
% Change
|
|||||||||
Gross U.S. product sales
|
$
|
748,839
|
|
|
|
|
$
|
561,255
|
|
|
|
|
$
|
187,584
|
|
|
33
|
%
|
||
Provision for U.S. product sales allowances and accruals:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Contractual adjustments
|
229,686
|
|
|
31
|
%
|
|
161,665
|
|
|
29
|
%
|
|
|
|
|
|
|
|||
Governmental rebates
|
86,983
|
|
|
12
|
%
|
|
57,774
|
|
|
10
|
%
|
|
|
|
|
|
|
|||
Total provision for U.S. product sales allowances and accruals
|
316,669
|
|
|
42
|
%
|
|
219,439
|
|
|
39
|
%
|
|
|
|
|
|
|
|||
U.S. product sales, net
|
$
|
432,170
|
|
|
|
|
$
|
341,816
|
|
|
|
|
$
|
90,354
|
|
|
26
|
%
|
|
Contractual Adjustments
|
|
Governmental Rebates
|
|
Total
|
||||||
Balance at January 1, 2015
|
$
|
26,408
|
|
|
$
|
29,102
|
|
|
$
|
55,510
|
|
Measurement period adjustments - Lumara Health acquisition
|
(2,619
|
)
|
|
(4,034
|
)
|
|
(6,653
|
)
|
|||
Current provisions relating to sales in current year
|
156,234
|
|
|
58,011
|
|
|
214,245
|
|
|||
Adjustments relating to sales in prior years
|
172
|
|
|
(237
|
)
|
|
(65
|
)
|
|||
Payments/returns relating to sales in current year
|
(131,214
|
)
|
|
(33,073
|
)
|
|
(164,287
|
)
|
|||
Payments/returns relating to sales in prior years
|
(18,804
|
)
|
|
(24,002
|
)
|
|
(42,806
|
)
|
|||
Balance at December 31, 2015
|
$
|
30,177
|
|
|
$
|
25,767
|
|
|
$
|
55,944
|
|
Current provisions relating to sales in current year
|
224,894
|
|
|
93,035
|
|
|
317,929
|
|
|||
Adjustments relating to sales in prior years
|
(2,348
|
)
|
|
(6,052
|
)
|
|
(8,400
|
)
|
|||
Payments/returns relating to sales in current year
|
(181,150
|
)
|
|
(41,636
|
)
|
|
(222,786
|
)
|
|||
Payments/returns relating to sales in prior years
|
(23,973
|
)
|
|
(19,715
|
)
|
|
(43,688
|
)
|
|||
Balance at December 31, 2016
|
$
|
47,600
|
|
|
$
|
51,399
|
|
|
$
|
98,999
|
|
|
Years Ended December 31,
|
|
2016 to 2015
|
|||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
Cost of product sales
|
$
|
96,314
|
|
|
$
|
78,509
|
|
|
$
|
17,805
|
|
|
23
|
%
|
Percentage of net product sales
|
22
|
%
|
|
23
|
%
|
|
|
|
|
|
Years Ended December 31,
|
|
2016 to 2015
|
||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
||||||
Cost of services
|
$
|
20,575
|
|
|
$
|
9,992
|
|
|
$
|
10,583
|
|
|
>100 %
|
Percentage of service revenues
|
21
|
%
|
|
41
|
%
|
|
|
|
|
|
Years Ended December 31,
|
|
2016 to 2015
|
|||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
External research and development expenses
|
|
|
|
|
|
|
|
|||||||
Makena
-related costs
|
$
|
19,113
|
|
|
$
|
10,820
|
|
|
$
|
8,293
|
|
|
77
|
%
|
Feraheme
-related costs
|
28,067
|
|
|
6,279
|
|
|
$
|
21,788
|
|
|
>100
|
%
|
||
Velo option
|
—
|
|
|
10,000
|
|
|
$
|
(10,000
|
)
|
|
(100
|
)%
|
||
Other external costs
|
3,252
|
|
|
1,799
|
|
|
$
|
1,453
|
|
|
81
|
%
|
||
Total
|
50,432
|
|
|
28,898
|
|
|
21,534
|
|
|
75
|
%
|
|||
Internal research and development expenses
|
15,652
|
|
|
13,980
|
|
|
1,672
|
|
|
12
|
%
|
|||
Total research and development expenses
|
$
|
66,084
|
|
|
$
|
42,878
|
|
|
$
|
23,206
|
|
|
54
|
%
|
•
|
Makena
: This project currently includes studies conducted as part of the post-approval commitments under the provisions of the FDA’s “Subpart H” Accelerated Approval regulations including: (a) an ongoing efficacy and safety clinical study of
Makena
; (b) an ongoing follow-up study of the children born to mothers from the efficacy and safety clinical study; and (c) a completed PK trial of women taking
Makena.
In addition, this project includes studies conducted as part of our
Makena
auto-injector development program, including a completion of the definitive PK study;
|
•
|
Feraheme to treat IDA in CKD patients
: This project currently includes the following: (a) a completed clinical study evaluating
Feraheme
treatment as compared to treatment to another IV iron and (b) a completed global multi-center randomized clinical trial to determine the safety and efficacy of repeat doses of
Feraheme
as compared to iron sucrose for the treatment of IDA in patients with hemodialysis dependent CKD (“FACT”). This project also includes a pediatric program as part of our post-approval Pediatric Research Equity Act requirement to support pediatric CKD labeling of
Feraheme,
which we suspended in 2015 due to difficulty in enrollment. In December 2016, we met with the FDA to develop a plan forward in order to satisfy this post-approval commitment for
Feraheme
and recently proposed a protocol to the FDA for a new pediatric study; and
|
•
|
Feraheme to treat IDA regardless of the underlying cause
: This project currently includes a randomized, double-blind multicenter non-inferiority trial that will evaluate the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension with
Feraheme
compared to ferric carboxymaltose infusion in adults with IDA, which was initiated in the first quarter of 2016. We currently expect to file an sNDA for this broader indication in mid-2017.
|
|
Years Ended December 31,
|
|
2016 to 2015
|
|||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
Compensation, payroll taxes and benefits
|
$
|
78,295
|
|
|
$
|
62,122
|
|
|
$
|
16,173
|
|
|
26
|
%
|
Professional, consulting and other outside services
|
114,813
|
|
|
78,981
|
|
|
35,832
|
|
|
45
|
%
|
|||
Fair value of contingent consideration liability
|
25,683
|
|
|
4,271
|
|
|
21,412
|
|
|
>100
|
%
|
|||
Amortization expense related to customer relationship intangible
|
12,529
|
|
|
1,061
|
|
|
11,468
|
|
|
>100
|
%
|
|||
Equity-based compensation expense
|
18,550
|
|
|
13,874
|
|
|
4,676
|
|
|
34
|
%
|
|||
Total selling, general and administrative expenses
|
$
|
249,870
|
|
|
$
|
160,309
|
|
|
$
|
89,561
|
|
|
56
|
%
|
•
|
$16.2 million
increase in compensation, payroll taxes and benefits primarily due to increased headcount resulting from the August 2015 CBR acquisition;
|
•
|
$25.0 million increase in sales and marketing, consulting, professional fees, and other expenses due to costs related to CBR marketing activities and revenue driven spend related to
Makena
;
|
•
|
$10.8 million increase in general and administrative, consulting, professional fees and other expenses primarily due to increased costs associated with the CBR acquisition;
|
•
|
$21.4 million
increase to the contingent consideration liability due to a $22.8 million increase in the
Makena-
related contingent consideration based on the expected timing of the milestone payments;
|
•
|
$11.5 million
increase in amortization expense related to the CBR customer relationship intangible due to the full period recognition of CBR amortization expense in
2016
compared to a partial period in
2015
following our August 2015 acquisition of CBR; and
|
•
|
$4.7 million
increase in equity-based compensation expense due primarily to an increase in the number of equity awards to new and existing employees, including additional employees from the CBR acquisition.
|
|
Years Ended December 31,
|
|
2016 to 2015
|
|||||||||||
|
2016
|
|
2015
|
|
$ Change
|
|
% Change
|
|||||||
Interest expense
|
$
|
(73,153
|
)
|
|
$
|
(53,251
|
)
|
|
$
|
(19,902
|
)
|
|
37
|
%
|
Loss on debt extinguishment
|
—
|
|
|
(10,449
|
)
|
|
10,449
|
|
|
(100
|
)%
|
|||
Interest and dividend income, net
|
3,149
|
|
|
1,512
|
|
|
1,637
|
|
|
>100
|
%
|
|||
Other income (expense)
|
189
|
|
|
(9,188
|
)
|
|
9,377
|
|
|
<(100
|
)%
|
|||
Total other income (expense)
|
$
|
(69,815
|
)
|
|
$
|
(71,376
|
)
|
|
$
|
1,561
|
|
|
(2
|
)%
|
•
|
$10.4 million
loss on debt extinguishment in
2015
as the result of the early repayment of the remaining $323.0 million outstanding principal amount of our then existing five-year term loan facility (the “2014 Term Loan Facility”); and
|
•
|
$9.4 million
decrease of other expenses as compared to
2015
, including a payment of a $6.8 million bridge loan commitment fee and $2.4 million in fees and expenses paid in 2015 as part of the early repayment of the 2014 Term Loan Facility.
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Effective tax rate
|
127
|
%
|
|
18
|
%
|
||
Income tax expense
|
$
|
11,538
|
|
|
$
|
7,065
|
|
|
Years Ended December 31,
|
|
2015 to 2014
|
|||||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
U.S. product sales, net
|
|
|
|
|
|
|
|
|||||||
Makena
|
$
|
251,615
|
|
|
$
|
22,513
|
|
|
$
|
229,102
|
|
|
>100
|
%
|
Feraheme
|
88,452
|
|
|
86,282
|
|
|
2,170
|
|
|
3
|
%
|
|||
MuGard
|
1,749
|
|
|
1,203
|
|
|
546
|
|
|
45
|
%
|
|||
Total
|
341,816
|
|
|
109,998
|
|
|
231,818
|
|
|
>100
|
%
|
|||
Service revenues, net
|
24,132
|
|
|
—
|
|
|
24,132
|
|
|
N/A
|
|
|||
License fee, collaboration and other revenues
|
52,328
|
|
|
14,386
|
|
|
37,942
|
|
|
>100
|
%
|
|||
Total Revenues
|
$
|
418,276
|
|
|
$
|
124,384
|
|
|
$
|
293,892
|
|
|
>100
|
%
|
|
Years Ended December 31,
|
||||
|
2015
|
|
2014
|
||
AmerisourceBergen Drug Corporation
|
25
|
%
|
|
34
|
%
|
Takeda Pharmaceuticals Company Limited
|
12
|
%
|
|
11
|
%
|
McKesson Corporation
|
11
|
%
|
|
21
|
%
|
Cardinal Health, Inc.
|
<10
|
%
|
|
15
|
%
|
|
Years Ended December 31,
|
|
2015 to 2014
|
||||||||||||||||
|
2015
|
|
Percent of
gross U.S. product sales |
|
2014
|
|
Percent of
gross U.S. product sales |
|
$ Change
|
|
% Change
|
||||||||
Gross U.S. product sales
|
$
|
561,255
|
|
|
|
|
$
|
190,512
|
|
|
|
|
$
|
370,743
|
|
|
>100 %
|
||
Provision for U.S. product sales allowances and accruals:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Contractual adjustments
|
161,665
|
|
|
29
|
%
|
|
73,262
|
|
|
38
|
%
|
|
|
|
|
|
|||
Governmental rebates
|
57,774
|
|
|
10
|
%
|
|
7,252
|
|
|
4
|
%
|
|
|
|
|
|
|||
Total provision for U.S. product sales allowances and accruals
|
219,439
|
|
|
39
|
%
|
|
80,514
|
|
|
42
|
%
|
|
|
|
|
|
|||
U.S. product sales, net
|
$
|
341,816
|
|
|
|
|
$
|
109,998
|
|
|
|
|
$
|
231,818
|
|
|
>100 %
|
|
Contractual Adjustments
|
|
Governmental Rebates
|
|
Total
|
||||||
Balance at January 1, 2014
|
$
|
7,059
|
|
|
$
|
487
|
|
|
$
|
7,546
|
|
Product reserves resulting from the Lumara Health acquisition
|
16,888
|
|
|
28,405
|
|
|
45,293
|
|
|||
Current provisions relating to sales in current year
|
67,952
|
|
|
786
|
|
|
68,738
|
|
|||
Adjustments relating to sales in prior years
|
(1,429
|
)
|
|
—
|
|
|
(1,429
|
)
|
|||
Payments/returns relating to sales in current year
|
(58,464
|
)
|
|
(401
|
)
|
|
(58,865
|
)
|
|||
Payments/returns relating to sales in prior years
|
(5,598
|
)
|
|
(175
|
)
|
|
(5,773
|
)
|
|||
Balance at December 31, 2014
|
$
|
26,408
|
|
|
$
|
29,102
|
|
|
$
|
55,510
|
|
Measurement period adjustments - Lumara Health acquisition
|
(2,619
|
)
|
|
(4,034
|
)
|
|
(6,653
|
)
|
|||
Current provisions relating to sales in current year
|
156,234
|
|
|
58,011
|
|
|
214,245
|
|
|||
Adjustments relating to sales in prior years
|
172
|
|
|
(237
|
)
|
|
(65
|
)
|
|||
Payments/returns relating to sales in current year
|
(131,214
|
)
|
|
(33,073
|
)
|
|
(164,287
|
)
|
|||
Payments/returns relating to sales in prior years
|
(18,804
|
)
|
|
(24,002
|
)
|
|
(42,806
|
)
|
|||
Balance at December 31, 2015
|
$
|
30,177
|
|
|
$
|
25,767
|
|
|
$
|
55,944
|
|
|
Years Ended December 31,
|
|
2015 to 2014
|
|||||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
Deferred license fee revenues recognized from Takeda
|
$
|
44,376
|
|
|
$
|
8,217
|
|
|
$
|
36,159
|
|
|
>100
|
%
|
Other revenues
|
7,952
|
|
|
5,169
|
|
|
2,783
|
|
|
54
|
%
|
|||
Deferred revenues recognized from 3SBio termination
|
—
|
|
|
1,000
|
|
|
(1,000
|
)
|
|
(100
|
)%
|
|||
Total license fee, collaboration and other revenues
|
$
|
52,328
|
|
|
$
|
14,386
|
|
|
$
|
37,942
|
|
|
>100
|
%
|
|
Years Ended December 31,
|
|
2015 to 2014
|
||||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
||||||
Cost of product sales
|
$
|
78,509
|
|
|
$
|
20,306
|
|
|
$
|
58,203
|
|
|
>100 %
|
Percentage of net product sales
|
23
|
%
|
|
18
|
%
|
|
|
|
|
•
|
$57.2 million increase related to $46.9 million of amortization of the
Makena
product intangible asset and $10.3 million of amortization of the
Makena
inventory step-up;
|
•
|
$2.0 million increase in costs related to
Makena
for a full year of sales in
2015
as compared to a partial year in
2014
;
|
•
|
$1.0 million increase in internal departmental costs, including salaries, benefits, and additional equity compensation; and
|
•
|
$2.8 million decrease in costs related to sales of
Feraheme
to Takeda, including the accelerated recognition of product costs in
2014
previously deferred as a result of the termination agreement with Takeda.
|
|
Years Ended December 31,
|
|
2015 to 2014
|
||||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
||||||
Cost of services
|
$
|
9,992
|
|
|
$
|
—
|
|
|
$
|
9,992
|
|
|
N/A
|
Percentage of service revenues
|
41
|
%
|
|
—
|
%
|
|
|
|
|
|
Years Ended December 31,
|
|
2015 to 2014
|
|||||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
External research and development expenses
|
|
|
|
|
|
|
|
|||||||
Makena
-related costs
|
$
|
10,820
|
|
|
$
|
1,703
|
|
|
$
|
9,117
|
|
|
100
|
%
|
Feraheme
-related costs
|
6,279
|
|
|
10,588
|
|
|
(4,309
|
)
|
|
(41
|
)%
|
|||
Velo option
|
10,000
|
|
|
—
|
|
|
10,000
|
|
|
N/A
|
|
|||
Other external costs
|
1,799
|
|
|
980
|
|
|
819
|
|
|
84
|
%
|
|||
Total
|
28,898
|
|
|
13,271
|
|
|
15,627
|
|
|
100
|
%
|
|||
Internal research and development expenses
|
13,980
|
|
|
10,889
|
|
|
3,091
|
|
|
28
|
%
|
|||
Total research and development expenses
|
$
|
42,878
|
|
|
$
|
24,160
|
|
|
$
|
18,718
|
|
|
77
|
%
|
|
Years Ended December 31,
|
|
2015 to 2014
|
|||||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
Compensation, payroll taxes and benefits
|
$
|
62,122
|
|
|
$
|
31,261
|
|
|
$
|
30,861
|
|
|
99
|
%
|
Professional, consulting and other outside services
|
78,981
|
|
|
34,767
|
|
|
44,214
|
|
|
>100
|
%
|
|||
Fair value of contingent consideration liability
|
4,271
|
|
|
(681
|
)
|
|
4,952
|
|
|
<(100
|
)%
|
|||
Amortization expense related to customer relationship intangible
|
1,061
|
|
|
—
|
|
|
1,061
|
|
|
N/A
|
|
|||
Equity-based compensation expense
|
13,874
|
|
|
6,907
|
|
|
6,967
|
|
|
>100
|
%
|
|||
Total selling, general and administrative expenses
|
$
|
160,309
|
|
|
$
|
72,254
|
|
|
$
|
88,055
|
|
|
>100
|
%
|
•
|
$30.9 million increase in compensation, payroll taxes and benefits primarily due to increased costs associated with additional personnel in connection with the November 2014 Lumara Health and August 2015 CBR acquisitions;
|
•
|
$27.0 million increase in sales and marketing consulting, professional fees, and other expenses primarily due to costs related to
Makena
marketing activities since the November 2014 acquisition and CBR activities since the August 2015 acquisition;
|
•
|
$17.2 million increase in general and administrative consulting, professional fees and other expenses primarily due to increased costs associated with consulting, finance, legal, and other infrastructure activities in support of our product portfolio expansion as well as costs associated with Lumara Health and CBR after the November 2014 and August 2015 acquisitions, respectively;
|
•
|
$7.0 million increase in equity-based compensation expense due primarily to the expense associated with equity awards to new and existing employees, including additional employees from the Lumara Health and CBR acquisitions as well as one-time charges associated with the departure of certain of our executive officers during 2015; and
|
•
|
$5.0 million increase to the contingent consideration liability due to a $6.7 million increase to the Lumara Health-related contingent consideration, partially offset by a $1.7 million reduction of the
MuGard-
related contingent consideration primarily resulting from a 2015 revision of our total projected
MuGard
sales.
|
|
Years Ended December 31,
|
|
2015 to 2014
|
|||||||||||
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|||||||
Interest expense
|
$
|
(53,251
|
)
|
|
$
|
(14,697
|
)
|
|
$
|
(38,554
|
)
|
|
>100
|
%
|
Loss on debt extinguishment
|
(10,449
|
)
|
|
—
|
|
|
(10,449
|
)
|
|
N/A
|
|
|||
Interest and dividend income, net
|
1,512
|
|
|
975
|
|
|
537
|
|
|
55
|
%
|
|||
Other income (expense)
|
(9,188
|
)
|
|
217
|
|
|
(9,405
|
)
|
|
<(100
|
)%
|
|||
Total other income (expense)
|
$
|
(71,376
|
)
|
|
$
|
(13,505
|
)
|
|
$
|
(57,871
|
)
|
|
>100
|
%
|
•
|
An additional
$38.6 million
in interest expense in
2015
, which was primarily comprised of the amortization of debt discount, contractual interest expense and amortization of debt issuance costs in connection with our current debt obligations as compared to
2014
;
|
•
|
$10.4 million
loss on debt extinguishment as the result of the early repayment in
2015
of the remaining $323.0 million outstanding principal amount of the 2014 Term Loan Facility; and
|
•
|
$9.4 million
increase of other expense, which included a $6.8 million bridge loan commitment fee paid in the third quarter of 2015 as part of the planned financing for the CBR acquisition, but which was not utilized to fund the acquisition, and $2.4 million in fees and expenses in
2015
from the 2014 Term Loan Facility that were expensed in accordance with accounting guidance for the modification of debt arrangements.
|
|
Years Ended December 31,
|
||||||
|
2015
|
|
2014
|
||||
Effective tax rate
|
18
|
%
|
|
(883
|
)%
|
||
Income tax expense (benefit)
|
$
|
7,065
|
|
|
$
|
(153,159
|
)
|
•
|
Non-cash operating items resulting in a net increase of
$191.0 million
, including deferred income taxes, equity-based compensation expense, a write-down of inventory, amortization of debt discount and debt issuance costs, amortization of premium/discount on purchased securities, change in fair value of contingent consideration, depreciation and amortization, loss on debt extinguishment and other non-cash items;
|
•
|
Change in accounts receivable of
$27.0 million
, a net increase in CBR deferred revenues of
$46.7 million
, partially offset by a decrease in net income of approximately
$35.3 million
.
|
•
|
Non-cash operating items resulting in a net increase of
$116.8 million
, including deferred income taxes, equity-based compensation expense, a write-down of inventory, amortization of debt discount and debt issuance costs, amortization of premium/discount on purchased securities, change in fair value of contingent consideration, depreciation and amortization, loss on debt extinguishment and other non-cash items;
|
•
|
$34.0 million of cash used in operating activities due to net increases in receivables and inventories, partially offset by decreases in prepaid and other current assets;
|
•
|
$9.2 million of cash provided by operating activities due to decreases in other long-term assets;
|
•
|
$7.9 million
of cash provided by operating activities due to increases in accounts payable and accrued expenses;
|
•
|
$24.2 million of cash used in operating activities due to decreases in deferred revenues and other long-term liabilities; and
|
•
|
$12.5 million
repayment of original issue discount related to the 2014 Term Loan Facility.
|
•
|
Non-cash operating items resulting in a net decrease of
$128.2 million
, including deferred income taxes, equity-based compensation expense, a write-down of inventory, amortization of debt discount and debt issuance costs, amortization of premium/discount on purchased securities, change in fair value of contingent consideration, depreciation and amortization, and other non-cash items;
|
•
|
$0.3 million of cash provided by operating activities due to increases in accounts receivable, inventories and prepaid and other current assets;
|
•
|
$10.7 million
of cash provided by operating activities due to increases in accounts payable and accrued expenses;
|
•
|
$9.2 million of cash used in operating activities due to decreases in deferred revenues and other long-term liabilities; and
|
•
|
$2.0 million of cash provided by operating activities due to decreases in other long-term assets.
|
|
Payment due by period
|
||||||||||||||||||
|
Total
|
|
Less than 1 year
|
|
1-3 years
|
|
3-5 years
|
|
More than 5 years
|
||||||||||
Facility lease obligations
|
$
|
10,801
|
|
|
$
|
2,925
|
|
|
$
|
6,711
|
|
|
$
|
1,165
|
|
|
$
|
—
|
|
Purchase commitments
|
5,260
|
|
|
2,630
|
|
|
2,630
|
|
|
—
|
|
|
—
|
|
|||||
2.5% Convertible Notes
|
210,831
|
|
|
5,000
|
|
|
205,831
|
|
|
—
|
|
|
—
|
|
|||||
2015 Term Loan Facility
|
391,096
|
|
|
36,310
|
|
|
62,706
|
|
|
292,080
|
|
|
—
|
|
|||||
2023 Senior Notes
|
775,625
|
|
|
39,375
|
|
|
78,750
|
|
|
78,750
|
|
|
578,750
|
|
|||||
Total
|
$
|
1,393,613
|
|
|
$
|
86,240
|
|
|
$
|
356,628
|
|
|
$
|
371,995
|
|
|
$
|
578,750
|
|
|
As of December 31,
|
||||||
|
2016
|
|
2015
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
274,305
|
|
|
$
|
228,705
|
|
Investments
|
304,781
|
|
|
237,626
|
|
||
Accounts receivable, net
|
92,375
|
|
|
85,678
|
|
||
Inventories
|
37,258
|
|
|
40,645
|
|
||
Receivable from collaboration
|
—
|
|
|
428
|
|
||
Prepaid and other current assets
|
9,839
|
|
|
13,592
|
|
||
Total current assets
|
718,558
|
|
|
606,674
|
|
||
Property, plant and equipment, net
|
24,460
|
|
|
28,725
|
|
||
Goodwill
|
639,484
|
|
|
639,188
|
|
||
Intangible assets, net
|
1,092,178
|
|
|
1,196,771
|
|
||
Restricted cash
|
2,593
|
|
|
2,593
|
|
||
Other long-term assets
|
1,153
|
|
|
2,259
|
|
||
Total assets
|
$
|
2,478,426
|
|
|
$
|
2,476,210
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
3,684
|
|
|
$
|
4,906
|
|
Accrued expenses
|
156,008
|
|
|
106,363
|
|
||
Current portion of long-term debt
|
21,166
|
|
|
17,500
|
|
||
Current portion of acquisition-related contingent consideration
|
97,068
|
|
|
96,967
|
|
||
Deferred revenues
|
34,951
|
|
|
20,185
|
|
||
Total current liabilities
|
312,877
|
|
|
245,921
|
|
||
Long-term liabilities:
|
|
|
|
|
|
||
Long-term debt, net
|
785,992
|
|
|
803,669
|
|
||
Convertible 2.5% notes, net
|
179,363
|
|
|
170,749
|
|
||
Acquisition-related contingent consideration
|
50,927
|
|
|
125,592
|
|
||
Deferred tax liabilities
|
197,066
|
|
|
189,145
|
|
||
Deferred revenues
|
14,850
|
|
|
5,093
|
|
||
Other long-term liabilities
|
2,962
|
|
|
3,777
|
|
||
Total liabilities
|
1,544,037
|
|
|
1,543,946
|
|
||
Commitments and contingencies (Note P)
|
|
|
|
|
|
||
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, 117,500,000 shares authorized; 34,336,147 and 34,733,117 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively
|
343
|
|
|
347
|
|
||
Additional paid-in capital
|
1,238,031
|
|
|
1,233,786
|
|
||
Accumulated other comprehensive loss
|
(3,838
|
)
|
|
(4,205
|
)
|
||
Accumulated deficit
|
(300,147
|
)
|
|
(297,664
|
)
|
||
Total stockholders’ equity
|
934,389
|
|
|
932,264
|
|
||
Total liabilities and stockholders’ equity
|
$
|
2,478,426
|
|
|
$
|
2,476,210
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues:
|
|
|
|
|
|
||||||
U.S. product sales, net
|
$
|
432,170
|
|
|
$
|
341,816
|
|
|
$
|
109,998
|
|
Service revenues, net
|
99,604
|
|
|
24,132
|
|
|
—
|
|
|||
License fee, collaboration and other revenues
|
317
|
|
|
52,328
|
|
|
14,386
|
|
|||
Total revenues
|
532,091
|
|
|
418,276
|
|
|
124,384
|
|
|||
Costs and expenses:
|
|
|
|
|
|
||||||
Cost of product sales (excluding impairment)
|
96,314
|
|
|
78,509
|
|
|
20,306
|
|
|||
Cost of services
|
20,575
|
|
|
9,992
|
|
|
—
|
|
|||
Research and development expenses
|
66,084
|
|
|
42,878
|
|
|
24,160
|
|
|||
Selling, general and administrative expenses
|
249,870
|
|
|
160,309
|
|
|
72,254
|
|
|||
Impairment of intangible assets
|
19,663
|
|
|
—
|
|
|
—
|
|
|||
Acquisition-related costs
|
—
|
|
|
11,232
|
|
|
9,478
|
|
|||
Restructuring expenses
|
715
|
|
|
4,136
|
|
|
2,023
|
|
|||
Total costs and expenses
|
453,221
|
|
|
307,056
|
|
|
128,221
|
|
|||
Operating income (loss)
|
78,870
|
|
|
111,220
|
|
|
(3,837
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest expense
|
(73,153
|
)
|
|
(53,251
|
)
|
|
(14,697
|
)
|
|||
Loss on debt extinguishment
|
—
|
|
|
(10,449
|
)
|
|
—
|
|
|||
Interest and dividend income
|
3,149
|
|
|
1,512
|
|
|
975
|
|
|||
Other income (expense)
|
189
|
|
|
(9,188
|
)
|
|
217
|
|
|||
Total other income (expense)
|
(69,815
|
)
|
|
(71,376
|
)
|
|
(13,505
|
)
|
|||
Income (loss) before income taxes
|
9,055
|
|
|
39,844
|
|
|
(17,342
|
)
|
|||
Income tax expense (benefit)
|
11,538
|
|
|
7,065
|
|
|
(153,159
|
)
|
|||
Net income (loss)
|
$
|
(2,483
|
)
|
|
$
|
32,779
|
|
|
$
|
135,817
|
|
Net income (loss) per share:
|
|
|
|
|
|
||||||
Basic
|
$
|
(0.07
|
)
|
|
$
|
1.04
|
|
|
$
|
6.06
|
|
Diluted
|
$
|
(0.07
|
)
|
|
$
|
0.93
|
|
|
$
|
5.45
|
|
Weighted average shares outstanding used to compute net income (loss) per share:
|
|
|
|
|
|
||||||
Basic
|
34,346
|
|
|
31,471
|
|
|
22,416
|
|
|||
Diluted
|
34,346
|
|
|
35,308
|
|
|
25,225
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net income (loss)
|
$
|
(2,483
|
)
|
|
$
|
32,779
|
|
|
$
|
135,817
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Unrealized gains (losses) on securities:
|
|
|
|
|
|
||||||
Holding gains (losses) arising during period, net of tax
|
261
|
|
|
(4
|
)
|
|
(191
|
)
|
|||
Reclassification adjustment for gains (losses) included in net income (loss), net of tax
|
106
|
|
|
(584
|
)
|
|
65
|
|
|||
Net unrealized gains (losses) on securities
|
367
|
|
|
(588
|
)
|
|
(126
|
)
|
|||
Total comprehensive income (loss)
|
$
|
(2,116
|
)
|
|
$
|
32,191
|
|
|
$
|
135,691
|
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|||||||||||||
|
Shares
|
|
Amount
|
|
Additional Paid-in Capital
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity
|
|||||||||||
Balance at December 31, 2013
|
21,772,571
|
|
|
$
|
218
|
|
|
$
|
641,941
|
|
|
$
|
(3,491
|
)
|
|
$
|
(466,260
|
)
|
|
$
|
172,408
|
|
Equity component of Convertible Notes, net of issuance costs
|
—
|
|
|
—
|
|
|
36,907
|
|
|
—
|
|
|
—
|
|
|
36,907
|
|
|||||
Purchase of convertible bond hedges, net of tax
|
—
|
|
|
—
|
|
|
(39,760
|
)
|
|
—
|
|
|
—
|
|
|
(39,760
|
)
|
|||||
Sale of warrants
|
—
|
|
|
—
|
|
|
25,620
|
|
|
—
|
|
|
—
|
|
|
25,620
|
|
|||||
Net shares issued in connection with the acquisition of Lumara Health
|
3,209,971
|
|
|
32
|
|
|
111,932
|
|
|
—
|
|
|
—
|
|
|
111,964
|
|
|||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units
|
617,008
|
|
|
6
|
|
|
8,492
|
|
|
—
|
|
|
—
|
|
|
8,498
|
|
|||||
Non-cash equity-based compensation
|
—
|
|
|
—
|
|
|
8,625
|
|
|
—
|
|
|
—
|
|
|
8,625
|
|
|||||
Unrealized losses on securities, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(126
|
)
|
|
—
|
|
|
(126
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
135,817
|
|
|
135,817
|
|
|||||
Balance at December 31, 2014
|
25,599,550
|
|
|
256
|
|
|
793,757
|
|
|
(3,617
|
)
|
|
(330,443
|
)
|
|
459,953
|
|
|||||
Shares issued in connection with financings, net of issuance costs of $24.7 million
|
8,196,362
|
|
|
82
|
|
|
407,395
|
|
|
—
|
|
|
—
|
|
|
407,477
|
|
|||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units
|
937,205
|
|
|
9
|
|
|
15,397
|
|
|
—
|
|
|
—
|
|
|
15,406
|
|
|||||
Non-cash equity-based compensation
|
—
|
|
|
—
|
|
|
17,237
|
|
|
—
|
|
|
—
|
|
|
17,237
|
|
|||||
Unrealized losses on securities, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(588
|
)
|
|
—
|
|
|
(588
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32,779
|
|
|
32,779
|
|
|||||
Balance at December 31, 2015
|
34,733,117
|
|
|
347
|
|
|
1,233,786
|
|
|
(4,205
|
)
|
|
(297,664
|
)
|
|
932,264
|
|
|||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units
|
355,450
|
|
|
3
|
|
|
227
|
|
|
—
|
|
|
—
|
|
|
230
|
|
|||||
Repurchase of common stock pursuant to the 2016 Share Repurchase Program
|
(831,744
|
)
|
|
(8
|
)
|
|
(19,992
|
)
|
|
—
|
|
|
—
|
|
|
(20,000
|
)
|
|||||
Issuance of common stock under employee stock purchase plan
|
79,324
|
|
|
1
|
|
|
1,467
|
|
|
—
|
|
|
—
|
|
|
1,468
|
|
|||||
Non-cash equity-based compensation
|
—
|
|
|
—
|
|
|
22,543
|
|
|
—
|
|
|
—
|
|
|
22,543
|
|
|||||
Unrealized gains on securities, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
367
|
|
|
—
|
|
|
367
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,483
|
)
|
|
(2,483
|
)
|
|||||
Balance at December 31, 2016
|
34,336,147
|
|
|
$
|
343
|
|
|
$
|
1,238,031
|
|
|
$
|
(3,838
|
)
|
|
$
|
(300,147
|
)
|
|
$
|
934,389
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
(2,483
|
)
|
|
$
|
32,779
|
|
|
$
|
135,817
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
99,886
|
|
|
69,103
|
|
|
6,984
|
|
|||
Impairment of intangible assets
|
19,663
|
|
|
—
|
|
|
—
|
|
|||
Provision for bad debt expense
|
3,209
|
|
|
—
|
|
|
—
|
|
|||
Amortization of premium/discount on purchased securities
|
624
|
|
|
2,152
|
|
|
2,080
|
|
|||
Write-down of inventory to net realizable value
|
—
|
|
|
1,235
|
|
|
1,309
|
|
|||
Gain (loss) on disposal of property and equipment
|
—
|
|
|
—
|
|
|
(103
|
)
|
|||
Non-cash equity-based compensation expense
|
22,543
|
|
|
17,237
|
|
|
8,625
|
|
|||
Non-cash loss on debt extinguishment
|
—
|
|
|
6,426
|
|
|
—
|
|
|||
Amortization of debt discount and debt issuance costs
|
12,105
|
|
|
11,379
|
|
|
6,870
|
|
|||
Gains on investments, net
|
38
|
|
|
(14
|
)
|
|
(114
|
)
|
|||
Change in fair value of contingent consideration
|
25,683
|
|
|
4,271
|
|
|
(681
|
)
|
|||
Deferred income taxes
|
7,279
|
|
|
5,007
|
|
|
(153,159
|
)
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable, net
|
(9,906
|
)
|
|
(36,913
|
)
|
|
3,588
|
|
|||
Inventories
|
(2,355
|
)
|
|
(5,237
|
)
|
|
(1,360
|
)
|
|||
Receivable from collaboration
|
428
|
|
|
4,090
|
|
|
(4,239
|
)
|
|||
Prepaid and other current assets
|
4,095
|
|
|
4,034
|
|
|
2,331
|
|
|||
Accounts payable and accrued expenses
|
49,037
|
|
|
7,876
|
|
|
10,694
|
|
|||
Deferred revenues
|
24,522
|
|
|
(22,197
|
)
|
|
(8,384
|
)
|
|||
Payment of contingent consideration in excess of acquisition date fair value
|
(8,116
|
)
|
|
—
|
|
|
—
|
|
|||
Repayment of term loan attributable to original issue discount
|
—
|
|
|
(12,491
|
)
|
|
—
|
|
|||
Other assets and liabilities
|
(30
|
)
|
|
7,244
|
|
|
1,156
|
|
|||
Net cash provided by operating activities
|
246,222
|
|
|
95,981
|
|
|
11,414
|
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Acquisition of Lumara Health, net of acquired cash
|
—
|
|
|
562
|
|
|
(595,602
|
)
|
|||
Acquisition of CBR, net
|
—
|
|
|
(682,356
|
)
|
|
—
|
|
|||
Proceeds from sales or maturities of investments
|
127,479
|
|
|
208,966
|
|
|
223,568
|
|
|||
Purchase of investments
|
(194,723
|
)
|
|
(424,759
|
)
|
|
(63,747
|
)
|
|||
Change in restricted cash
|
—
|
|
|
(195
|
)
|
|
2,883
|
|
|||
Capital expenditures
|
(5,460
|
)
|
|
(1,259
|
)
|
|
(44
|
)
|
|||
Net cash used in investing activities
|
(72,704
|
)
|
|
(899,041
|
)
|
|
(432,942
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Proceeds from the issuance of common stock, net of underwriting discount and other expenses
|
—
|
|
|
407,477
|
|
|
—
|
|
|||
Long-term debt principal payments
|
(17,502
|
)
|
|
(327,509
|
)
|
|
—
|
|
|||
Proceeds from long-term debt
|
—
|
|
|
834,750
|
|
|
527,509
|
|
|||
Payment of debt issuance costs
|
—
|
|
|
(10,004
|
)
|
|
(7,760
|
)
|
|||
Proceeds from issuance of warrants
|
—
|
|
|
—
|
|
|
25,620
|
|
|||
Purchase of convertible bond hedges
|
—
|
|
|
—
|
|
|
(39,760
|
)
|
|||
Payment of contingent consideration
|
(92,130
|
)
|
|
(456
|
)
|
|
(270
|
)
|
|||
Payment to former CBR shareholders
|
—
|
|
|
(7,195
|
)
|
|
—
|
|
|||
Payments for repurchases of common stock
|
(20,000
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from the exercise of stock options
|
1,468
|
|
|
15,406
|
|
|
8,499
|
|
|||
Proceeds from the issuance of common stock under ESPP
|
2,417
|
|
|
—
|
|
|
—
|
|
|||
Payments of employee tax withholding related to equity-based compensation
|
(2,171
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash (used in) provided by financing activities
|
(127,918
|
)
|
|
912,469
|
|
|
513,838
|
|
|||
Net increase in cash and cash equivalents
|
45,600
|
|
|
109,409
|
|
|
92,310
|
|
|||
Cash and cash equivalents at beginning of the year
|
228,705
|
|
|
119,296
|
|
|
26,986
|
|
|||
Cash and cash equivalents at end of the year
|
$
|
274,305
|
|
|
$
|
228,705
|
|
|
$
|
119,296
|
|
Supplemental data of cash flow information:
|
|
|
|
|
|
||||||
Cash paid for taxes
|
$
|
5,309
|
|
|
$
|
2,373
|
|
|
$
|
—
|
|
Cash paid for interest
|
$
|
62,381
|
|
|
$
|
28,014
|
|
|
$
|
2,500
|
|
Non-cash investing activities:
|
|
|
|
|
|
||||||
Fair value of acquisition-related contingent consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
205,000
|
|
Fair value of common stock issued in connection with the Lumara Health acquisition
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
111,964
|
|
|
Years Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
AmerisourceBergen Drug Corporation
|
22
|
%
|
|
25
|
%
|
|
34
|
%
|
McKesson Corporation
|
11
|
%
|
|
11
|
%
|
|
21
|
%
|
Cardinal Health, Inc.
|
<10
|
%
|
|
<10
|
%
|
|
15
|
%
|
Takeda Pharmaceuticals Company Limited
|
—
|
%
|
|
12
|
%
|
|
11
|
%
|
|
December 31,
|
||||
|
2016
|
|
2015
|
||
McKesson Corporation
|
32
|
%
|
|
<10
|
%
|
AmerisourceBergen Drug Corporation
|
13
|
%
|
|
43
|
%
|
|
Useful Life
|
Buildings and improvements
|
15 - 40 Years
|
Computer equipment and software
|
5 Years
|
Furniture and fixtures
|
5 Years
|
Leasehold improvements
|
Lesser of Lease or Asset Life
|
Laboratory and production equipment
|
5 Years
|
Land improvements
|
10 Years
|
•
|
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.
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Gross U.S. product sales
|
$
|
748,839
|
|
|
$
|
561,255
|
|
|
$
|
190,512
|
|
Provision for U.S. product sales allowances and accruals:
|
|
|
|
|
|
||||||
Contractual adjustments
|
229,686
|
|
|
161,665
|
|
|
73,262
|
|
|||
Governmental rebates
|
86,983
|
|
|
57,774
|
|
|
7,252
|
|
|||
Total provision for U.S. product sales allowances and accruals
|
316,669
|
|
|
219,439
|
|
|
80,514
|
|
|||
U.S. product sales, net
|
$
|
432,170
|
|
|
$
|
341,816
|
|
|
$
|
109,998
|
|
•
|
The milestone consideration received is commensurate with either the level of effort required to achieve the milestone or the enhancement of the value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone;
|
•
|
The milestone is related solely to our past performance; and
|
•
|
The milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement.
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net income (loss) - basic
|
$
|
(2,483
|
)
|
|
$
|
32,779
|
|
|
$
|
135,817
|
|
Dilutive effect of convertible 2.5% notes
|
—
|
|
|
—
|
|
|
1,654
|
|
|||
Net income (loss) - diluted
|
$
|
(2,483
|
)
|
|
$
|
32,779
|
|
|
$
|
137,471
|
|
|
|
|
|
|
|
|
|
|
|||
Weighted average common shares outstanding
|
34,346
|
|
|
31,471
|
|
|
22,416
|
|
|||
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|||
Warrants
|
—
|
|
|
2,466
|
|
|
—
|
|
|||
Stock options and RSUs
|
—
|
|
|
1,371
|
|
|
520
|
|
|||
Convertible 2.5% notes
|
—
|
|
|
—
|
|
|
2,289
|
|
|||
Shares used in calculating dilutive net income (loss) per share
|
34,346
|
|
|
35,308
|
|
|
25,225
|
|
|||
|
|
|
|
|
|
|
|
|
|||
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|||
Basic
|
$
|
(0.07
|
)
|
|
$
|
1.04
|
|
|
$
|
6.06
|
|
Diluted
|
$
|
(0.07
|
)
|
|
$
|
0.93
|
|
|
$
|
5.45
|
|
|
Years Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Options to purchase shares of common stock
|
2,590
|
|
|
1,619
|
|
|
2,708
|
|
Shares of common stock issuable upon the vesting of RSUs
|
613
|
|
|
167
|
|
|
322
|
|
Warrants
|
7,382
|
|
|
—
|
|
|
7,382
|
|
Convertible 2.5% notes
|
7,382
|
|
|
7,382
|
|
|
—
|
|
Total
|
17,967
|
|
|
9,168
|
|
|
10,412
|
|
|
Total Acquisition
Date Fair Value |
||
Cash consideration
|
$
|
700,000
|
|
Estimated working capital, indebtedness and other adjustments
|
(17,837
|
)
|
|
Purchase price paid at closing
|
682,163
|
|
|
Cash paid on finalization of the net working capital, indebtedness and other adjustments
|
193
|
|
|
Total purchase price
|
$
|
682,356
|
|
|
Total Acquisition Date Fair Value
|
||
Accounts receivable
|
$
|
8,660
|
|
Inventories
|
3,825
|
|
|
Prepaid and other current assets
|
8,480
|
|
|
Restricted cash - short-term
|
30,752
|
|
|
Property, plant and equipment
|
29,401
|
|
|
Customer relationships
|
297,000
|
|
|
Trade name and trademarks
|
65,000
|
|
|
Favorable lease asset
|
358
|
|
|
Deferred income tax assets
|
5,062
|
|
|
Other long-term assets
|
496
|
|
|
Accounts payable
|
(2,853
|
)
|
|
Accrued expenses
|
(13,770
|
)
|
|
Deferred revenues - short-term
|
(3,100
|
)
|
|
Payable to former CBR shareholders
|
(37,947
|
)
|
|
Deferred income tax liabilities
|
(149,873
|
)
|
|
Other long-term liabilities
|
(506
|
)
|
|
Total estimated identifiable net assets
|
$
|
240,985
|
|
Goodwill
|
441,371
|
|
|
Total
|
$
|
682,356
|
|
•
|
A one-time payment of
$100.0 million
payable upon achievement of
$300.0 million
in aggregate net sales in any consecutive
12
-month period, commencing in the month
f
ollowing the Lumara Health Acquisition Date (“the First Milestone”); plus
|
•
|
A one-time payment of
$100.0 million
payable upon achievement of
$400.0 million
in aggregate net sales in any consecutive
12
-month period commencing in the month following the last month in the First Milestone period (the “Second Milestone”); if the Third Milestone payment (described below) has been or is required to be made prior to achieving the Second Milestone, the Second Milestone payment shall be reduced from
$100.0 million
to
$50.0 million
; plus
|
•
|
A one-time payment of
$50.0 million
payable if aggregate net sales equal or exceed
$700.0 million
in any consecutive
24
calendar month period (which may include the First Milestone period) (the “Third Milestone”); however, no Third Milestone payment will be made if the Second Milestone payment has been or is required to be made in the full amount of
$100.0 million
; plus
|
•
|
A one-time payment of
$100.0 million
payable upon achievement of
$500.0 million
in aggregate net sales in any consecutive
12
-month period commencing in the month following the last month in the Second Milestone period (the “Fourth Milestone”); plus
|
•
|
A one-time payment of
$50.0 million
payable upon achievement of
$200.0 million
in aggregate net sales in each of the five (
5
) consecutive calendar years from and including the 2015 calendar year to the 2019 calendar year (the “Fifth Milestone”).
|
|
Total Acquisition Date Fair Value
|
||
Cash consideration
|
$
|
600,000
|
|
Fair value of AMAG common stock issued
|
111,964
|
|
|
Fair value of contingent milestone payments
|
205,000
|
|
|
Estimated working capital and other adjustments
|
821
|
|
|
Purchase price paid at closing
|
917,785
|
|
|
Less:
|
|
||
Cash received on finalization of the net working capital and other adjustments
|
(562
|
)
|
|
Cash acquired from Lumara Health
|
(5,219
|
)
|
|
Total purchase price
|
$
|
912,004
|
|
|
Total Acquisition Date Fair Value
|
||
Accounts receivable
|
$
|
36,852
|
|
Inventories
|
30,300
|
|
|
Prepaid and other current assets
|
3,322
|
|
|
Deferred income tax assets
|
102,355
|
|
|
Property and equipment
|
60
|
|
|
Makena base technology
|
797,100
|
|
|
IPR&D
|
79,100
|
|
|
Restricted cash - long term
|
1,997
|
|
|
Other long-term assets
|
3,412
|
|
|
Accounts payable
|
(3,807
|
)
|
|
Accrued expenses
|
(36,561
|
)
|
|
Deferred income tax liabilities
|
(295,676
|
)
|
|
Other long-term liabilities
|
(4,563
|
)
|
|
Total estimated identifiable net assets
|
$
|
713,891
|
|
Goodwill
|
198,113
|
|
|
Total
|
$
|
912,004
|
|
|
Years Ended December 31,
|
||||
|
2015
|
|
2014
|
||
Pro forma combined revenues
|
490,451
|
|
|
364,447
|
|
Pro forma combined net income (loss)
|
28,217
|
|
|
(57,739
|
)
|
|
December 31, 2016
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
Estimated
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate debt securities
|
|
|
|
|
|
|
|
||||||||
Due in one year or less
|
$
|
106,430
|
|
|
$
|
3
|
|
|
$
|
(69
|
)
|
|
$
|
106,364
|
|
Due in one to three years
|
139,742
|
|
|
32
|
|
|
(281
|
)
|
|
139,493
|
|
||||
U.S. treasury and government agency securities
|
|
|
|
|
|
|
|
|
|||||||
Due in one year or less
|
1,021
|
|
|
—
|
|
|
—
|
|
|
1,021
|
|
||||
Due in one to three years
|
11,395
|
|
|
—
|
|
|
(52
|
)
|
|
11,343
|
|
||||
Commercial paper
|
|
|
|
|
|
|
|
|
|||||||
Due in one year or less
|
40,560
|
|
|
—
|
|
|
—
|
|
|
40,560
|
|
||||
Certificates of deposit
|
|
|
|
|
|
|
|
||||||||
Due in one year or less
|
6,000
|
|
|
—
|
|
|
—
|
|
|
6,000
|
|
||||
Total investments
|
$
|
305,148
|
|
|
$
|
35
|
|
|
$
|
(402
|
)
|
|
$
|
304,781
|
|
|
December 31, 2015
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
Estimated
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate debt securities
|
|
|
|
|
|
|
|
||||||||
Due in one year or less
|
$
|
27,964
|
|
|
$
|
—
|
|
|
$
|
(38
|
)
|
|
$
|
27,926
|
|
Due in one to three years
|
173,652
|
|
|
3
|
|
|
(904
|
)
|
|
172,751
|
|
||||
Commercial paper
|
|
|
|
|
|
|
|
|
|
|
|
||||
Due in one year or less
|
34,452
|
|
|
2
|
|
|
(5
|
)
|
|
34,449
|
|
||||
Municipal securities
|
|
|
|
|
|
|
|
|
|
|
|
||||
Due in one year or less
|
2,500
|
|
|
—
|
|
|
—
|
|
|
2,500
|
|
||||
Total investments
|
$
|
238,568
|
|
|
$
|
5
|
|
|
$
|
(947
|
)
|
|
$
|
237,626
|
|
|
Fair Value Measurements at December 31, 2016 Using:
|
||||||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for
Identical Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
9,951
|
|
|
$
|
9,951
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt securities
|
245,857
|
|
|
—
|
|
|
245,857
|
|
|
—
|
|
||||
U.S. treasury and government agency securities
|
12,364
|
|
|
—
|
|
|
12,364
|
|
|
—
|
|
||||
Commercial paper
|
40,560
|
|
|
—
|
|
|
40,560
|
|
|
—
|
|
||||
Certificates of deposit
|
6,000
|
|
|
—
|
|
|
6,000
|
|
|
—
|
|
||||
Total Assets
|
$
|
314,732
|
|
|
$
|
9,951
|
|
|
$
|
304,781
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent consideration - Lumara Health
|
$
|
145,974
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
145,974
|
|
Contingent consideration - MuGard
|
2,021
|
|
|
—
|
|
|
—
|
|
|
2,021
|
|
||||
Total Liabilities
|
$
|
147,995
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
147,995
|
|
Balance as of January 1, 2015
|
$
|
218,702
|
|
Payments made
|
(456
|
)
|
|
Adjustments to fair value of contingent consideration
|
4,271
|
|
|
Other adjustments
|
42
|
|
|
Balance as of December 31, 2015
|
$
|
222,559
|
|
Payments made
|
(100,246
|
)
|
|
Adjustments to fair value of contingent consideration
|
25,682
|
|
|
Balance as of December 31, 2016
|
$
|
147,995
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Land
|
$
|
700
|
|
|
$
|
700
|
|
Land improvements
|
300
|
|
|
300
|
|
||
Building and improvements
|
9,500
|
|
|
9,500
|
|
||
Computer equipment and software
|
13,866
|
|
|
13,193
|
|
||
Furniture and fixtures
|
2,401
|
|
|
1,725
|
|
||
Leasehold improvements
|
3,718
|
|
|
1,717
|
|
||
Laboratory and production equipment
|
6,449
|
|
|
5,683
|
|
||
Construction in progress
|
1,619
|
|
|
786
|
|
||
|
38,553
|
|
|
33,604
|
|
||
Less: accumulated depreciation
|
(14,093
|
)
|
|
(4,879
|
)
|
||
Property, plant and equipment, net
|
$
|
24,460
|
|
|
$
|
28,725
|
|
|
|
||
|
|
||
Balance at January 1, 2015
|
$
|
205,824
|
|
Goodwill acquired through CBR acquisition
|
441,075
|
|
|
Measurement period adjustments related to Lumara Health acquisition
|
(7,711
|
)
|
|
Balance as of December 31, 2015
|
639,188
|
|
|
Measurement period adjustments related to CBR acquisition
|
296
|
|
|
Balance as of December 31, 2016
|
$
|
639,484
|
|
|
December 31, 2016
|
|
December 31, 2015
|
||||||||||||||||||||||||
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Accumulated
|
|
|
||||||||||||||
|
Cost
|
|
Amortization
|
|
Impairments
|
|
Net
|
|
Cost
|
|
Amortization
|
|
Net
|
||||||||||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Makena
base technology
|
$
|
797,100
|
|
|
$
|
128,732
|
|
|
$
|
—
|
|
|
$
|
668,368
|
|
|
$
|
797,100
|
|
|
$
|
56,540
|
|
|
$
|
740,560
|
|
CBR customer relationships
|
297,000
|
|
|
13,590
|
|
|
—
|
|
|
283,410
|
|
|
297,000
|
|
|
1,061
|
|
|
295,939
|
|
|||||||
CBR Favorable lease
|
358
|
|
|
119
|
|
|
239
|
|
|
—
|
|
|
358
|
|
|
63
|
|
|
295
|
|
|||||||
MuGard Rights
|
16,893
|
|
|
1,169
|
|
|
15,724
|
|
|
—
|
|
|
16,893
|
|
|
1,016
|
|
|
15,877
|
|
|||||||
|
1,111,351
|
|
|
143,610
|
|
|
15,963
|
|
|
951,778
|
|
|
1,111,351
|
|
|
58,680
|
|
|
1,052,671
|
|
|||||||
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Makena
IPR&D
|
79,100
|
|
|
—
|
|
|
—
|
|
|
79,100
|
|
|
79,100
|
|
|
—
|
|
|
79,100
|
|
|||||||
CBR trade names and trademarks
|
65,000
|
|
|
—
|
|
|
3,700
|
|
|
61,300
|
|
|
65,000
|
|
|
—
|
|
|
65,000
|
|
|||||||
Total intangible assets
|
$
|
1,255,451
|
|
|
$
|
143,610
|
|
|
$
|
19,663
|
|
|
$
|
1,092,178
|
|
|
$
|
1,255,451
|
|
|
$
|
58,680
|
|
|
$
|
1,196,771
|
|
Period
|
|
Estimated Amortization Expense
|
||
Year Ending December 31, 2017
|
|
$
|
119,900
|
|
Year Ending December 31, 2018
|
|
81,433
|
|
|
Year Ending December 31, 2019
|
|
48,283
|
|
|
Year Ending December 31, 2020
|
|
46,845
|
|
|
Year Ending December 31, 2021
|
|
46,767
|
|
|
Thereafter
|
|
608,550
|
|
|
Total
|
|
$
|
951,778
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Commercial rebates, fees and returns
|
$
|
89,466
|
|
|
$
|
45,161
|
|
Professional, license, and other fees and expenses
|
34,962
|
|
|
27,070
|
|
||
Interest expense
|
16,683
|
|
|
18,411
|
|
||
Salaries, bonuses, and other compensation
|
14,823
|
|
|
12,838
|
|
||
Restructuring expense
|
74
|
|
|
2,883
|
|
||
Total accrued expenses
|
$
|
156,008
|
|
|
$
|
106,363
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
4,259
|
|
|
2,058
|
|
|
—
|
|
|||
Total current
|
$
|
4,259
|
|
|
$
|
2,058
|
|
|
$
|
—
|
|
Deferred:
|
|
|
|
|
|
||||||
Federal
|
$
|
9,815
|
|
|
$
|
9,819
|
|
|
$
|
(142,884
|
)
|
State
|
(2,536
|
)
|
|
(4,812
|
)
|
|
(10,275
|
)
|
|||
Total deferred
|
$
|
7,279
|
|
|
$
|
5,007
|
|
|
$
|
(153,159
|
)
|
Total income tax expense (benefit)
|
$
|
11,538
|
|
|
$
|
7,065
|
|
|
$
|
(153,159
|
)
|
|
Years Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Statutory U.S. federal tax rate
|
35.0
|
%
|
|
35.0
|
%
|
|
(34.0
|
)%
|
State taxes, net of federal benefit
|
6.4
|
|
|
0.1
|
|
|
(7.9
|
)
|
Equity-based compensation expense
|
34.0
|
|
|
0.4
|
|
|
10.6
|
|
Contingent consideration
|
69.9
|
|
|
4.7
|
|
|
3.1
|
|
Transaction costs
|
—
|
|
|
3.9
|
|
|
9.7
|
|
Other permanent items, net
|
21.2
|
|
|
3.2
|
|
|
3.2
|
|
Tax credits
|
(32.3
|
)
|
|
(1.7
|
)
|
|
(3.0
|
)
|
Write-down of acquired state net operating losses
|
114.2
|
|
|
—
|
|
|
—
|
|
Valuation allowance
|
(115.2
|
)
|
|
(28.0
|
)
|
|
(864.9
|
)
|
Other, net
|
(5.8
|
)
|
|
0.1
|
|
|
—
|
|
Effective tax rate
|
127.4
|
%
|
|
17.7
|
%
|
|
(883.2
|
)%
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Assets
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
116,275
|
|
|
$
|
172,944
|
|
Tax credit carryforwards
|
9,415
|
|
|
6,262
|
|
||
Deferred revenue
|
1,811
|
|
|
626
|
|
||
Equity-based compensation expense
|
8,045
|
|
|
5,464
|
|
||
Capitalized research & development
|
18,284
|
|
|
25,216
|
|
||
Reserves
|
8,018
|
|
|
8,900
|
|
||
Contingent consideration
|
4,140
|
|
|
1,258
|
|
||
Other
|
9,769
|
|
|
9,636
|
|
||
Liabilities
|
|
|
|
||||
Property, plant and equipment depreciation
|
(2,145
|
)
|
|
(2,844
|
)
|
||
Intangible assets and inventory
|
(367,667
|
)
|
|
(400,357
|
)
|
||
Debt instruments
|
(1,040
|
)
|
|
(1,213
|
)
|
||
Other
|
(542
|
)
|
|
(3,178
|
)
|
||
|
(195,637
|
)
|
|
(177,286
|
)
|
||
Valuation allowance
|
(1,429
|
)
|
|
(11,859
|
)
|
||
Net deferred tax liabilities
|
$
|
(197,066
|
)
|
|
$
|
(189,145
|
)
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Uncertain tax benefits at the beginning of the year
|
$
|
12,695
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Additions based on tax positions related to the current year
|
300
|
|
|
12,695
|
|
|
—
|
|
|||
Additions for tax positions from prior years
|
379
|
|
|
—
|
|
|
—
|
|
|||
Subtractions for tax positions from prior years
|
(44
|
)
|
|
—
|
|
|
—
|
|
|||
Uncertain tax benefits at the end of the year
|
$
|
13,330
|
|
|
$
|
12,695
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Beginning balance
|
$
|
(4,205
|
)
|
|
$
|
(3,617
|
)
|
Other comprehensive income (loss) before reclassifications
|
261
|
|
|
(4
|
)
|
||
Reclassification adjustment for gains (losses) included in net income (loss)
|
106
|
|
|
(584
|
)
|
||
Ending balance
|
$
|
(3,838
|
)
|
|
$
|
(4,205
|
)
|
|
2007 Equity
|
|
2000 Equity
|
|
2013 Lumara
|
|
Inducement
|
|
|
|||||
|
Plan
|
|
Plan
|
|
Equity Plan
|
|
Grants
|
|
Total
|
|||||
Outstanding at December 31, 2015
|
1,963,162
|
|
|
14,040
|
|
|
96,000
|
|
|
830,975
|
|
|
2,904,177
|
|
Granted
|
581,648
|
|
|
—
|
|
|
92,400
|
|
|
110,000
|
|
|
784,048
|
|
Exercised
|
(134,455
|
)
|
|
—
|
|
|
—
|
|
|
(21,250
|
)
|
|
(155,705
|
)
|
Expired or terminated
|
(251,533
|
)
|
|
(8,840
|
)
|
|
(54,219
|
)
|
|
(104,750
|
)
|
|
(419,342
|
)
|
Outstanding at December 31, 2016
|
2,158,822
|
|
|
5,200
|
|
|
134,181
|
|
|
814,975
|
|
|
3,113,178
|
|
|
2007 Equity
|
|
2000 Equity
|
|
2013 Lumara
|
|
Inducement
|
|
|
|||||
|
Plan
|
|
Plan
|
|
Equity Plan
|
|
Grants
|
|
Total
|
|||||
Outstanding at December 31, 2015
|
446,330
|
|
|
—
|
|
|
52,350
|
|
|
155,675
|
|
|
654,355
|
|
Granted
|
659,618
|
|
|
—
|
|
|
1,500
|
|
|
64,500
|
|
|
725,618
|
|
Vested
|
(209,599
|
)
|
|
—
|
|
|
(16,749
|
)
|
|
(74,219
|
)
|
|
(300,567
|
)
|
Expired or terminated
|
(122,545
|
)
|
|
—
|
|
|
(9,407
|
)
|
|
(10,500
|
)
|
|
(142,452
|
)
|
Outstanding at December 31, 2016
|
773,804
|
|
|
—
|
|
|
27,694
|
|
|
135,456
|
|
|
936,954
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Cost of product sales and services
|
$
|
520
|
|
|
$
|
371
|
|
|
$
|
122
|
|
Research and development
|
3,476
|
|
|
2,992
|
|
|
1,596
|
|
|||
Selling, general and administrative
|
18,547
|
|
|
13,874
|
|
|
6,907
|
|
|||
Total equity-based compensation expense
|
$
|
22,543
|
|
|
$
|
17,237
|
|
|
$
|
8,625
|
|
Income tax effect
|
(6,232
|
)
|
|
(4,885
|
)
|
|
—
|
|
|||
After-tax effect of equity-based compensation expense
|
$
|
16,311
|
|
|
$
|
12,352
|
|
|
$
|
8,625
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
Non-Employee
|
|
|
|
Non-Employee
|
|
|
|
Non-Employee
|
|
Employees
|
|
Directors
|
|
Employees
|
|
Directors
|
|
Employees
|
|
Directors
|
Risk free interest rate (%)
|
1.32
|
|
1.10
|
|
1.55
|
|
1.24
|
|
1.56
|
|
1.28
|
Expected volatility (%)
|
49
|
|
54
|
|
47
|
|
46
|
|
47
|
|
46
|
Expected option term (years)
|
5.00
|
|
3.00
|
|
5.00
|
|
4.00
|
|
5.00
|
|
4.00
|
Dividend yield
|
none
|
|
none
|
|
none
|
|
none
|
|
none
|
|
none
|
|
December 31, 2016
|
||||||||||||
|
Options
|
|
Weighted Average Exercise Price
|
|
Weighted Average Remaining Contractual Term
|
|
Aggregate Intrinsic Value
($ in thousands) |
||||||
Outstanding at beginning of year
|
2,904,177
|
|
|
$
|
34.97
|
|
|
—
|
|
|
$
|
—
|
|
Granted
|
784,048
|
|
|
24.59
|
|
|
—
|
|
|
—
|
|
||
Exercised
|
(155,705
|
)
|
|
17.99
|
|
|
—
|
|
|
—
|
|
||
Expired and/or forfeited
|
(419,342
|
)
|
|
44.10
|
|
|
—
|
|
|
—
|
|
||
Outstanding at end of year
|
3,113,178
|
|
|
$
|
31.97
|
|
|
7.4
|
|
|
$
|
28,113
|
|
Outstanding at end of year - vested and unvested expected to vest
|
2,915,930
|
|
|
$
|
31.53
|
|
|
7.4
|
|
|
$
|
27,038
|
|
Exercisable at end of year
|
1,536,405
|
|
|
$
|
27.92
|
|
|
6.3
|
|
|
$
|
17,928
|
|
|
December 31, 2016
|
|||||
|
Restricted Stock Units
|
|
Weighted Average Grant Date Fair Value
|
|||
Outstanding at beginning of year
|
654,355
|
|
|
$
|
36.90
|
|
Granted
|
725,618
|
|
|
22.28
|
|
|
Vested
|
(300,567
|
)
|
|
30.38
|
|
|
Forfeited
|
(142,452
|
)
|
|
26.66
|
|
|
Outstanding at end of year
|
936,954
|
|
|
$
|
28.78
|
|
Outstanding at end of year and expected to vest
|
781,165
|
|
|
$
|
28.79
|
|
Period
|
|
Future Minimum Lease Payments
|
||
Year Ending December 31, 2017
|
|
$
|
2,925
|
|
Year Ending December 31, 2018
|
|
2,123
|
|
|
Year Ending December 31, 2019
|
|
2,258
|
|
|
Year Ending December 31, 2020
|
|
2,330
|
|
|
Year Ending December 31, 2021
|
|
1,165
|
|
|
Total
|
|
$
|
10,801
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
2023 Senior Notes
|
$
|
489,612
|
|
|
$
|
488,481
|
|
2015 Term Loan Facility
|
317,546
|
|
|
332,688
|
|
||
2.5% Convertible Notes
|
179,363
|
|
|
170,749
|
|
||
Total long-term debt
|
986,521
|
|
|
991,918
|
|
||
Less: current maturities
|
21,166
|
|
|
17,500
|
|
||
Long-term debt, net of current maturities
|
$
|
965,355
|
|
|
$
|
974,418
|
|
1)
|
during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least
20
trading days (whether or not consecutive) during a period of
30
consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to
130%
of the conversion price on each applicable trading day;
|
2)
|
during the
five
business day period after any
five
consecutive trading day period (the “measurement period”) in which the trading price per
$1,000
principal amount of the Convertible Notes for each trading day of the measurement period was less than
98%
of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; or
|
3)
|
upon the occurrence of specified corporate event.
|
|
December 31, 2016
|
||
Liability component:
|
|
|
|
Principal
|
$
|
199,998
|
|
Less: debt discount and issuance costs, net
|
(20,635
|
)
|
|
Net carrying amount
|
$
|
179,363
|
|
|
Years Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Contractual interest expense
|
$
|
5,000
|
|
|
$
|
5,000
|
|
|
$
|
4,375
|
|
Amortization of debt issuance costs
|
1,072
|
|
|
985
|
|
|
800
|
|
|||
Amortization of debt discount
|
7,544
|
|
|
6,927
|
|
|
5,629
|
|
|||
Total interest expense
|
$
|
13,616
|
|
|
$
|
12,912
|
|
|
$
|
10,804
|
|
Period
|
|
Future Annual Principal Payments
|
||
Year Ending December 31, 2017
|
|
$
|
21,166
|
|
Year Ending December 31, 2018
|
|
17,500
|
|
|
Year Ending December 31, 2019
|
|
217,498
|
|
|
Year Ending December 31, 2020
|
|
17,500
|
|
|
Year Ending December 31, 2021
|
|
254,459
|
|
|
Thereafter
|
|
500,000
|
|
|
Total
|
|
$
|
1,028,123
|
|
|
Years Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Accrued restructuring, beginning of period
|
$
|
2,883
|
|
|
$
|
1,953
|
|
Employee severance, benefits and related costs
|
715
|
|
|
3,874
|
|
||
Payments
|
(3,524
|
)
|
|
(2,944
|
)
|
||
Accrued restructuring, end of period
|
$
|
74
|
|
|
$
|
2,883
|
|
|
March 31, 2016
|
|
June 30, 2016
|
|
September 30, 2016
|
|
December 31, 2016
|
||||||||
Total revenues
|
$
|
109,300
|
|
|
$
|
127,419
|
|
|
$
|
143,782
|
|
|
$
|
151,591
|
|
Gross profit (a)
|
85,474
|
|
|
84,563
|
|
|
113,092
|
|
|
116,349
|
|
||||
Operating expenses
|
78,026
|
|
|
66,486
|
|
|
74,332
|
|
|
101,764
|
|
||||
Net income (loss)
|
$
|
(7,527
|
)
|
|
$
|
(596
|
)
|
|
$
|
16,196
|
|
|
$
|
(10,557
|
)
|
Net income (loss) per share - basic
|
$
|
(0.22
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
0.47
|
|
|
$
|
(0.31
|
)
|
Net income (loss) per share - diluted
|
$
|
(0.22
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
0.43
|
|
|
$
|
(0.31
|
)
|
|
March 31, 2015
|
|
June 30, 2015
|
|
September 30, 2015
|
|
December 31, 2015
|
||||||||
Total revenues (b)
|
$
|
89,505
|
|
|
$
|
123,884
|
|
|
$
|
96,152
|
|
|
$
|
108,735
|
|
Gross profit (b)
|
68,479
|
|
|
104,205
|
|
|
73,803
|
|
|
83,288
|
|
||||
Operating expenses (b)
|
39,671
|
|
|
43,081
|
|
|
75,188
|
|
|
60,615
|
|
||||
Net income (loss) (c)
|
$
|
12,904
|
|
|
$
|
33,258
|
|
|
$
|
(20,584
|
)
|
|
$
|
7,201
|
|
Net income (loss) per share - basic
|
$
|
0.47
|
|
|
$
|
1.09
|
|
|
$
|
(0.62
|
)
|
|
$
|
0.21
|
|
Net income (loss) per share - diluted
|
$
|
0.39
|
|
|
$
|
0.82
|
|
|
$
|
(0.62
|
)
|
|
$
|
0.20
|
|
(a)
|
Gross profit for the second quarter of 2016 includes the impairment charge of
$15.7 million
relating to the MuGard Rights intangible asset.
|
|
Balance at Beginning of Period
|
|
Additions (a)
|
|
Deductions Charged to Reserves
|
|
Balance at End of Period
|
||||||||
Year ended December 31, 2016:
|
|
|
|
|
|
|
|
||||||||
Allowance for doubtful accounts (a)
|
$
|
900
|
|
|
$
|
3,209
|
|
|
$
|
(948
|
)
|
|
$
|
3,161
|
|
Accounts receivable allowances (b)
|
$
|
10,783
|
|
|
$
|
122,792
|
|
|
$
|
(124,042
|
)
|
|
$
|
9,533
|
|
Rebates, fees and returns reserves
|
$
|
45,162
|
|
|
$
|
186,941
|
|
|
$
|
(142,637
|
)
|
|
$
|
89,466
|
|
Valuation allowance for deferred tax assets (c)
|
$
|
11,859
|
|
|
$
|
632
|
|
|
$
|
(11,062
|
)
|
|
$
|
1,429
|
|
Year ended December 31, 2015:
|
|
|
|
|
|
|
|
||||||||
Allowance for doubtful accounts (a)
|
$
|
—
|
|
|
$
|
900
|
|
|
$
|
—
|
|
|
$
|
900
|
|
Accounts receivable allowances (b)
|
$
|
11,618
|
|
|
$
|
93,887
|
|
|
$
|
(94,722
|
)
|
|
$
|
10,783
|
|
Rebates, fees and returns reserves
|
$
|
43,892
|
|
|
$
|
120,293
|
|
|
$
|
(119,023
|
)
|
|
$
|
45,162
|
|
Valuation allowance for deferred tax assets (c)
|
$
|
33,557
|
|
|
$
|
—
|
|
|
$
|
(21,698
|
)
|
|
$
|
11,859
|
|
Year ended December 31, 2014:
|
|
|
|
|
|
|
|
||||||||
Accounts receivable allowances (b)
|
$
|
2,728
|
|
|
$
|
60,054
|
|
|
$
|
(51,164
|
)
|
|
$
|
11,618
|
|
Rebates, fees and returns reserves
|
$
|
4,819
|
|
|
$
|
52,548
|
|
|
$
|
(13,475
|
)
|
|
$
|
43,892
|
|
Valuation allowance for deferred tax assets (c)
|
$
|
166,416
|
|
|
$
|
20,299
|
|
|
$
|
(153,158
|
)
|
|
$
|
33,557
|
|
(a)
|
Additions to allowance for doubtful accounts are recorded in selling, general and administrative expenses. Additions to rebates, fees and returns reserves are recorded as a reduction of revenues.
|
(b)
|
These accounts receivable allowances represent discounts and other chargebacks related to the provision for our product sales.
|
(c)
|
The valuation allowance for deferred tax assets includes purchase accounting adjustments and other activity related to our acquisition of Lumara Health.
|
|
|
|
Exhibit
Number
|
|
Description
|
2.1
|
|
Agreement and Plan of Merger, dated as of September 28, 2014, by and among Lumara Health Inc., AMAG Pharmaceuticals, Inc., Snowbird, Inc., and Lunar Representative, LLC as the Stockholders’ Representative (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed September 29, 2014, File No. 001-10865)
|
2.2
|
|
Stock Purchase Agreement, dated as of June 29, 2015, by and among CBR Holdco, LLC, CBR Acquisition Holdings Corp. and AMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed June 29, 2015, File No. 001-10865)
|
3.1, 4.1
|
|
Certificate of Incorporation of AMAG Pharmaceuticals, Inc., as restated (incorporated herein by reference to Exhibits 3.1 and 4.1to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, File No. 001-10865)
|
3.2,4.2
|
|
Certificate of Amendment to Restated Certificate of Incorporation of AMAG Pharmaceuticals, Inc. as filed on May 21, 2015 with the Delaware Secretary of State (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed May 28, 2015, File No. 001-10865)
|
3.3, 4.3
|
|
Amended and Restated By-Laws of AMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed December 17, 2015, File No. 001-10865)
|
3.4, 4.4
|
|
Certificate of Designation of Series A Junior Participating Preferred Stock (incorporated herein by reference to Exhibits 3.1 and 4.1 to the Company’s Current Report on Form 8-K filed September 4, 2009, File No. 0-14732)
|
4.6
|
|
Specimen certificate representing AMAG Pharmaceuticals, Inc.’s Common Stock (incorporated herein by reference to Exhibit 4.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, File No. 001-10865)
|
4.7
|
|
Rights Agreement, dated as of September 4, 2009 by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, 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)
|
4.8
|
|
Amendment to Rights Agreement, dated as of May 10, 2012, by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)
|
4.9
|
|
Amendment to Rights Agreement, dated as of February 11, 2014, by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
4.10
|
|
NOL Amendment to Rights Agreement, dated as of September 26, 2014, by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed September 29, 2014, File No. 001-10865)
|
4.11
|
|
Form of Rights 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)
|
4.12
|
|
Base Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust, National Association (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
4.13
|
|
First Supplemental Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust, National Association (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
4.14
|
|
Form of 2.50% Convertible Senior Note due 2019 (incorporated herein by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
4.16
|
|
Indenture, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the Guarantors party thereto and Wilmington Trust, National Association, as trustee (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed August 17, 2015, File No. 001-10865)
|
4.17
|
|
Form of 7.875% Senior Note due 2023 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed August 17, 2015, File No. 001-10865)
|
10.1*
|
|
Representative Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.2 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, File No. 001-10865)
|
10.2*
|
|
AMAG Pharmaceuticals, Inc.’s Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, File No. 001-10865)
|
10.3*
|
|
AMAG Pharmaceuticals, Inc.’s Amended and Restated 2000 Stock Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed December 14, 2005, File No. 0-14732)
|
10.4*
|
|
AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 19, 2013, File No. 001-10865)
|
10.5*
|
|
First Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Appendix B to the Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, File No. 001-10865)
|
10.6*
|
|
Second Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 15, 2016, File No. 001-10865)
|
10.7*
|
|
AMAG Pharmaceuticals, Inc. 2015 Employee Stock Purchase Plan (incorporated herein by reference to Appendix C to the Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, File No. 001-10865)
|
10.8*
|
|
Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.6 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, File No. 001-10865)
|
10.9*
|
|
Form of Incentive Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)
|
10.10*
|
|
Form of Non-Qualified Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2017 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)
|
10.11*
|
|
Form of Restricted Stock Unit Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.11 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.12*
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)
|
10.13*
|
|
Form of Restricted Stock Unit Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, File No. 001-10865)
|
10.14*
|
|
Non-Plan Restricted Stock Unit Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)
|
10.15*
|
|
Non-Plan Stock Option Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)
|
10.16*
|
|
Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-8 filed August 7, 2013, File No. 333-190435)
|
10.17*
|
|
Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 10.18 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.18*
|
|
Form of Employment Agreement between AMAG Pharmaceuticals, Inc. and each of its executive officers (other than William K. Heiden) (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.19*
|
|
Employment Agreement dated as of February 7, 2014 between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, File No. 001-10865)
|
10.20
|
|
Lease Agreement, dated as of May 22, 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. This Lease Agreement was assigned in June 2013. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed May 29, 2008, File No. 0-14732)
|
10.21
|
|
Assignment and Assumption of Lease, dated as of June 10, 2013, by and among AMAG Pharmaceuticals, Inc., Mortimer B. Zuckerman and Edward H. Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 and Shire Human Genetic Therapies, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865)
|
10.22
|
|
Lease Agreement, dated as of June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865)
|
10.23
|
|
First Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC, dated March 24, 2015 (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)
|
10.24
|
|
Second Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC, dated December 4, 2015 (incorporated herein by reference to Exhibit 10.30 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.25
|
|
Third Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC, dated December 7, 2015 (incorporated herein by reference to Exhibit 10.31 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.26
|
|
License Agreement between AMAG Pharmaceuticals, Inc. and Abeona Therapeutics, Inc. (formerly known as PlasmaTech Biopharmaceuticals, Inc. and Access Pharmaceuticals, Inc.) dated as of June 6, 2013 (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865) (confidential treatment previously granted)
|
10.27
|
|
Commercial Supply Agreement, dated effective as of August 29, 2012, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, File No. 001-10865) (confidential treatment previously granted)
|
10.28
|
|
Amendment No.1 to Commercial Supply Agreement, dated October 3, 2013, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.54 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, File No. 001-10865) (confidential treatment previously granted)
|
10.29
|
|
Amendment No. 2 to Commercial Supply Agreement, dated April 28, 2015, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.30
|
|
Amendment No. 3 to Commercial Supply Agreement, dated October 19, 2015, by and between the Company and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.36 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.31
|
|
Pharmaceutical Manufacturing and Supply Agreement, dated effective as of January 8, 2010, by and between AMAG Pharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, File No. 001-10865) (confidential treatment previously granted)
|
10.32
|
|
Amendment No. 1 to Pharmaceutical Manufacturing and Supply Agreement, dated July 5, 2014, by and between AMAG Pharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, File No. 001-10865)
|
10.33
|
|
Amendment No. 2 to Pharmaceutical Manufacturing and Supply Agreement, dated June 19, 2015, by and between AMAG Pharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DPI Newco LLC as assignee from DSM Pharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.34+
|
|
Amended and Restated Technical Transfer and Supply Agreement, dated as of December 19, 2016, by and between AMAG Pharmaceuticals, Inc. and the Pfizer CentreOne Group of Pfizer, Inc. (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.35
|
|
Development and License Agreement, dated September 30, 2014, by and between Lumara Health Inc and Antares Pharma, Inc. (incorporated herein by reference to Exhibit 10.42 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.36
|
|
License Agreement, dated January 8, 2017, by and between AMAG Pharmaceuticals, Inc. and Palatin Technologies, Inc., (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 3, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.37
|
|
Termination Agreement, dated December 29, 2014, by and between AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011, File No. 001-10865) (confidential treatment previously granted)
|
10.38
|
|
Underwriting Agreement, dated as of February 11, 2014, among AMAG Pharmaceuticals, Inc. and J.P. Morgan Securities LLC, on its own behalf and as representative of the several underwriters named in Schedule 1 thereto (incorporated herein by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.39
|
|
Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.40
|
|
Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.41
|
|
Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.42
|
|
Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.43
|
|
Amendment to Warrant Transaction, dated as of February 23, 2015, by and between AMAG Pharmaceuticals, Inc. and J.P. Morgan Securities LLC, as agent (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)
|
10.44
|
|
Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.45
|
|
Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.6 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.46
|
|
Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.47
|
|
Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.8 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.48
|
|
Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.9 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.49
|
|
Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.10 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.50
|
|
Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.11 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.51
|
|
Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.52
|
|
Credit Agreement, dated as of November 12, 2014, by and among AMAG Pharmaceuticals, Inc., the financial institutions and agents listed therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed November 12, 2014, File No. 001-10865)
|
10.53
|
|
First Amendment to Credit Agreement, dated March 31, 2015, by and among AMAG Pharmaceuticals, Inc., the Lenders named therein, and Jefferies Finance LLC, as administrative agent (incorporated herein by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)
|
10.54
|
|
Credit Agreement, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the financial institutions and agents listed therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed August 17, 2015, File No. 001-10865)
|
10.55
|
|
Underwriting Agreement, dated as of July 30, 2015, among AMAG Pharmaceuticals, Inc., Jefferies LLC and Barclays Capital Inc., as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed July 31, 2015, File No. 001-10865)
|
10.56
|
|
Underwriting Agreement, dated as of February 25, 2015, among AMAG Pharmaceuticals, Inc., J.P. Morgan Securities LLC and Deutsche Bank Securities Inc., as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed February 26, 2015, File No. 001-10865)
|
21.1+
|
|
Subsidiaries of AMAG Pharmaceuticals, Inc.
|
23.1+
|
|
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm
|
24.1
|
|
Power of Attorney (included on the signature page(s) hereto)
|
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 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-Oxley Act 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
|
101.INS+
|
|
XBRL Instance Document
|
101.SCH+
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL+
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF+
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB+
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
AMAG PHARMACEUTICALS, INC.
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By:
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/s/ William K. Heiden
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William K. Heiden
Chief Executive Officer
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Date:
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February 17, 2017
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Name
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Title
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Date
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/s/ William K. Heiden
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Chief Executive Officer (Principal Executive Officer) and Director
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February 17, 2017
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William K. Heiden
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/s/ Edward Myles
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Senior Vice President of Finance, Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer)
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February 17, 2017
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Edward Myles
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/s/ Barbara Deptula
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Director
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February 17, 2017
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Barbara Deptula
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/s/ John Fallon, M.D.
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Director
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February 17, 2017
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John Fallon, M.D.
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/s/ Brian P. Kelley
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Director
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February 17, 2017
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Brian P. Kelley
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/s/ Robert J. Perez
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Director
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February 17, 2017
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Robert J. Perez
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/s/ Lesley Russell, MB. Ch.B., MRCP
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Director
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February 17, 2017
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Lesley Russell, MB. Ch.B., MRCP
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/s/ Gino Santini
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Director
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February 17, 2017
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Gino Santini
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/s/ Davey S. Scoon
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Director
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February 17, 2017
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Davey S. Scoon
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/s/ James Sulat
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Director
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February 17, 2017
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James Sulat
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Exhibit
Number
|
|
Description
|
2.1
|
|
Agreement and Plan of Merger, dated as of September 28, 2014, by and among Lumara Health Inc., AMAG Pharmaceuticals, Inc., Snowbird, Inc., and Lunar Representative, LLC as the Stockholders’ Representative (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed September 29, 2014, File No. 001-10865)
|
2.2
|
|
Stock Purchase Agreement, dated as of June 29, 2015, by and among CBR Holdco, LLC, CBR Acquisition Holdings Corp. and AMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed June 29, 2015, File No. 001-10865)
|
3.1, 4.1
|
|
Certificate of Incorporation of AMAG Pharmaceuticals, Inc., as restated (incorporated herein by reference to Exhibits 3.1 and 4.1to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, File No. 001-10865)
|
3.2,4.2
|
|
Certificate of Amendment to Restated Certificate of Incorporation of AMAG Pharmaceuticals, Inc. as filed on May 21, 2015 with the Delaware Secretary of State (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed May 28, 2015, File No. 001-10865)
|
3.3, 4.3
|
|
Amended and Restated By-Laws of AMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed December 17, 2015, File No. 001-10865)
|
3.4, 4.4
|
|
Certificate of Designation of Series A Junior Participating Preferred Stock (incorporated herein by reference to Exhibits 3.1 and 4.1 to the Company’s Current Report on Form 8-K filed September 4, 2009, File No. 0-14732)
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4.6
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|
Specimen certificate representing AMAG Pharmaceuticals, Inc.’s Common Stock (incorporated herein by reference to Exhibit 4.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, File No. 001-10865)
|
4.7
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|
Rights Agreement, dated as of September 4, 2009 by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, 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)
|
4.8
|
|
Amendment to Rights Agreement, dated as of May 10, 2012, by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)
|
4.9
|
|
Amendment to Rights Agreement, dated as of February 11, 2014, by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
4.10
|
|
NOL Amendment to Rights Agreement, dated as of September 26, 2014, by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed September 29, 2014, File No. 001-10865)
|
4.11
|
|
Form of Rights 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)
|
4.12
|
|
Base Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust, National Association (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
4.13
|
|
First Supplemental Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust, National Association (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
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4.14
|
|
Form of 2.50% Convertible Senior Note due 2019 (incorporated herein by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
4.16
|
|
Indenture, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the Guarantors party thereto and Wilmington Trust, National Association, as trustee (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed August 17, 2015, File No. 001-10865)
|
4.17
|
|
Form of 7.875% Senior Note due 2023 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed August 17, 2015, File No. 001-10865)
|
10.1*
|
|
Representative Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.2 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, File No. 001-10865)
|
10.2*
|
|
AMAG Pharmaceuticals, Inc.’s Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, File No. 001-10865)
|
10.3*
|
|
AMAG Pharmaceuticals, Inc.’s Amended and Restated 2000 Stock Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed December 14, 2005, File No. 0-14732)
|
10.4*
|
|
AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 19, 2013, File No. 001-10865)
|
10.5*
|
|
First Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Appendix B to the Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, File No. 001-10865)
|
10.6*
|
|
Second Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 15, 2016, File No. 001-10865)
|
10.7*
|
|
AMAG Pharmaceuticals, Inc. 2015 Employee Stock Purchase Plan (incorporated herein by reference to Appendix C to the Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, File No. 001-10865)
|
10.8*
|
|
Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.6 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, File No. 001-10865)
|
10.9*
|
|
Form of Incentive Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)
|
10.10*
|
|
Form of Non-Qualified Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2017 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)
|
10.11*
|
|
Form of Restricted Stock Unit Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.11 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.12*
|
|
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)
|
10.13*
|
|
Form of Restricted Stock Unit Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, File No. 001-10865)
|
10.14*
|
|
Non-Plan Restricted Stock Unit Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)
|
10.15*
|
|
Non-Plan Stock Option Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)
|
10.16*
|
|
Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-8 filed August 7, 2013, File No. 333-190435)
|
10.17*
|
|
Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 10.18 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.18*
|
|
Form of Employment Agreement between AMAG Pharmaceuticals, Inc. and each of its executive officers (other than William K. Heiden) (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.19*
|
|
Employment Agreement dated as of February 7, 2014 between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, File No. 001-10865)
|
10.20
|
|
Lease Agreement, dated as of May 22, 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. This Lease Agreement was assigned in June 2013. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed May 29, 2008, File No. 0-14732)
|
10.21
|
|
Assignment and Assumption of Lease, dated as of June 10, 2013, by and among AMAG Pharmaceuticals, Inc., Mortimer B. Zuckerman and Edward H. Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 and Shire Human Genetic Therapies, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865)
|
10.22
|
|
Lease Agreement, dated as of June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865)
|
10.23
|
|
First Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC, dated March 24, 2015 (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)
|
10.24
|
|
Second Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC, dated December 4, 2015 (incorporated herein by reference to Exhibit 10.30 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.25
|
|
Third Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC, dated December 7, 2015 (incorporated herein by reference to Exhibit 10.31 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)
|
10.26
|
|
License Agreement between AMAG Pharmaceuticals, Inc. and Abeona Therapeutics, Inc. (formerly known as PlasmaTech Biopharmaceuticals, Inc. and Access Pharmaceuticals, Inc.) dated as of June 6, 2013 (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865) (confidential treatment previously granted)
|
10.27
|
|
Commercial Supply Agreement, dated effective as of August 29, 2012, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, File No. 001-10865) (confidential treatment previously granted)
|
10.28
|
|
Amendment No.1 to Commercial Supply Agreement, dated October 3, 2013, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.54 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, File No. 001-10865) (confidential treatment previously granted)
|
10.29
|
|
Amendment No. 2 to Commercial Supply Agreement, dated April 28, 2015, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.30
|
|
Amendment No. 3 to Commercial Supply Agreement, dated October 19, 2015, by and between the Company and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.36 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.31
|
|
Pharmaceutical Manufacturing and Supply Agreement, dated effective as of January 8, 2010, by and between AMAG Pharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, File No. 001-10865) (confidential treatment previously granted)
|
10.32
|
|
Amendment No. 1 to Pharmaceutical Manufacturing and Supply Agreement, dated July 5, 2014, by and between AMAG Pharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, File No. 001-10865)
|
10.33
|
|
Amendment No. 2 to Pharmaceutical Manufacturing and Supply Agreement, dated June 19, 2015, by and between AMAG Pharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DPI Newco LLC as assignee from DSM Pharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.34+
|
|
Amended and Restated Technical Transfer and Supply Agreement, dated as of December 19, 2016, by and between AMAG Pharmaceuticals, Inc. and the Pfizer CentreOne Group of Pfizer, Inc. (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.35
|
|
Development and License Agreement, dated September 30, 2014, by and between Lumara Health Inc and Antares Pharma, Inc. (incorporated herein by reference to Exhibit 10.42 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865) (confidential treatment previously granted)
|
10.36
|
|
License Agreement, dated January 8, 2017, by and between AMAG Pharmaceuticals, Inc. and Palatin Technologies, Inc., (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 3, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.37
|
|
Termination Agreement, dated December 29, 2014, by and between AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011, File No. 001-10865) (confidential treatment previously granted)
|
10.38
|
|
Underwriting Agreement, dated as of February 11, 2014, among AMAG Pharmaceuticals, Inc. and J.P. Morgan Securities LLC, on its own behalf and as representative of the several underwriters named in Schedule 1 thereto (incorporated herein by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.39
|
|
Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.40
|
|
Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.41
|
|
Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.42
|
|
Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.43
|
|
Amendment to Warrant Transaction, dated as of February 23, 2015, by and between AMAG Pharmaceuticals, Inc. and J.P. Morgan Securities LLC, as agent (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)
|
10.44
|
|
Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.45
|
|
Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.6 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.46
|
|
Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.47
|
|
Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.8 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.48
|
|
Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.9 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.49
|
|
Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.10 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.50
|
|
Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada (incorporated herein by reference to Exhibit 10.11 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.51
|
|
Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)
|
10.52
|
|
Credit Agreement, dated as of November 12, 2014, by and among AMAG Pharmaceuticals, Inc., the financial institutions and agents listed therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed November 12, 2014, File No. 001-10865)
|
10.53
|
|
First Amendment to Credit Agreement, dated March 31, 2015, by and among AMAG Pharmaceuticals, Inc., the Lenders named therein, and Jefferies Finance LLC, as administrative agent (incorporated herein by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)
|
10.54
|
|
Credit Agreement, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the financial institutions and agents listed therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed August 17, 2015, File No. 001-10865)
|
10.55
|
|
Underwriting Agreement, dated as of July 30, 2015, among AMAG Pharmaceuticals, Inc., Jefferies LLC and Barclays Capital Inc., as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed July 31, 2015, File No. 001-10865)
|
10.56
|
|
Underwriting Agreement, dated as of February 25, 2015, among AMAG Pharmaceuticals, Inc., J.P. Morgan Securities LLC and Deutsche Bank Securities Inc., as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed February 26, 2015, File No. 001-10865)
|
21.1+
|
|
Subsidiaries of AMAG Pharmaceuticals, Inc.
|
23.1+
|
|
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm
|
24.1
|
|
Power of Attorney (included on the signature page(s) hereto)
|
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 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-Oxley Act 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
|
101.INS+
|
|
XBRL Instance Document
|
101.SCH+
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL+
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF+
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB+
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
|
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.
|
PFIZER INC.
|
AMAG PHARMACEUTICALS, INC.
|
By: /s/ Kevin Orfan
(Signature)
|
By: /s/ William K. Heiden
(Signature)
|
Name: Kevin Orfan
|
Name: William K. Heiden
|
Title: Vice President
Pfizer CentreOne
Global Pharmaceutical Services
|
Chief Executive Officer
|
Test Method
|
Acceptance
Criteria |
Method of Acceptance
|
Appearance (Visual)
|
[…***…]
|
Pfizer to Test
|
Color (Visual)
|
[…***…]
|
Vendor CoA
|
Visible impurities (Visual)
|
[…***…]
|
Vendor CoA
|
Identification - IR ( USP <197K> )
|
[…***…]
|
Pfizer to Test
|
Assay (UV Spectroscopy)
|
[…***…]
|
Vendor CoA
|
Free Caproic Acid (USP Titrimetric Assay)
|
[…***…]
|
Vendor CoA
|
Melting Point (USP <741> Class Ia)
|
[…***…]
|
Vendor CoA
|
Related Substances (Ordinary Impurities)- TLC
(USP <466>)
|
[…***…]
|
Vendor CoA
|
Residual Solvents (Gas Chromatography) USP <467>
Cyclohexane Hexane Methanol Methylene chloride |
[…***…]
|
Vendor CoA
|
Specific Rotation (USP <781S>; 25°C/1% in chloroform/anhydrous substance)
|
[…***…]
|
Vendor CoA
|
Water – KF (USP <921>, Method I)
|
[…***…]
|
Vendor CoA
|
Bioburden EP2.6.12 / USP <61>
(Total Viable Aerobic Count)
|
[…***…]
|
Pfizer to test
|
Bacterial Endotoxin
(USP <85>; Gel-Clot Limit Test) |
[…***…]
|
Pfizer to test
|
Stability Testing
|
Req.
|
Not Req.
|
N/A
|
Responsibility
|
Cost
|
|
Pfizer
|
Client
|
|||||
Engineering stability
|
|
X
|
|
|
|
N/A
|
Registration batch stability
|
X
|
|
|
X
|
|
[…***…]
|
Annual Commercial Product stability
|
X
|
|
|
|
|
[…***…]
|
Total Cost:
|
TBD
|
[…***…]
|
||||
Payment:
|
[…***…]
|
|
||||
Timing:
|
TBD
|
|
/s/ PricewaterhouseCoopers LLP
|
|
Boston, Massachusetts
|
|
February 17, 2017
|
|
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 make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in 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 our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others 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 our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external 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 the effectiveness 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 most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) 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 are reasonably 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 internal control over financial reporting.
|
Date:
|
February 17, 2017
|
|
|
|
|
|
|
/s/ William K. Heiden
|
|
|
William K. Heiden
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
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 make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in 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 our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others 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 our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external 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 the effectiveness 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 most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) 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 are reasonably 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 internal control over financial reporting.
|
|
|
|
Date:
|
February 17, 2017
|
|
|
|
/s/ Edward Myles
|
|
|
Edward Myles
|
|
|
Senior Vice President of Finance, Chief Financial Officer and Treasurer
(Principal Financial Officer)
|
(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 the Company.
|
|
|
|
/s/ William K. Heiden
|
|
William K. Heiden
|
|
Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
|
|
February 17, 2017
|
|
(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 the Company.
|
|
|
|
/s/ Edward Myles
|
|
Edward Myles
|
|
Senior Vice President of Finance, Chief Financial Officer and Treasurer
|
|
(Principal Financial Officer)
|
|
|
|
|
February 17, 2017
|
|