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|AMAG Pharmaceuticals Reports Fourth Quarter and Full Year 2015 Financial Results|
Conference call scheduled for
“2015 was a pivotal year for AMAG as we drove revenue growth of Makena and Feraheme, expanded our presence in maternal health through the acquisition of Cord Blood Registry® and made an investment in a promising therapy for the potential treatment of severe preeclampsia,” said
Full Year 2015 Business Highlights:
Total costs and expenses for the fourth quarter of 2015 were
The company reported operating income of
Financial Results (Non-GAAP Basis)1,5
Total costs and expenses on a non-GAAP basis totaled
After deducting cash interest expense, the company generated fourth quarter 2015 non-GAAP cash earnings of
Full Year Ended
Net income totaled
Financial Results (Non-GAAP Basis)1,5
Balance Sheet Highlights
“The two transformative acquisitions that we completed in the past eighteen months fueled our significant top- and bottom-line growth in 2015, resulting in adjusted EBITDA of more than
Conference Call and Webcast Access
The call will be webcast with slides and accessible through the Investors section of the company’s website at www.amagpharma.com. The webcast replay will be available from approximately
Use of Non-GAAP Financial Measures
About Makena® (hydroxyprogesterone caproate injection)
The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
About Feraheme® (ferumoxytol)
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Feraheme is contraindicated in patients with a known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product.
For additional product information, please see full Prescribing Information, including Boxed Warning, available at www.feraheme.com.
About Cord Blood Registry (CBR)
Such risks and uncertainties include, among others, the possibility that a recent Paragraph IV certification notice letter regarding an Abbreviated New Drug Application (ANDA) submitted to the
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals® and Feraheme® are registered trademark of
1 See summaries of non-GAAP adjustments for the three and twelve months ended
2 Unaudited. Includes net product sales of Makena as though
3 Excludes a favorable
4 AMAG purchased
5 See share count reconciliation at the conclusion of this press release.
6 See reconciliation of 2016 financial guidance of non-GAAP CBR revenue, non-GAAP adjusted EBITDA and non-GAAP cash earnings at the conclusion of this press release.
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7 Adding back period write-down of deferred revenue from purchase accounting.
17 Adding back period write-down of deferred revenue from purchase accounting.
28 Convertible notes would be anti-dilutive in this period utilizing the “if-converted” method, which adjusts net income for the after-tax interest expense applicable to the convertible notes.