- Fourth quarter 2015 non-GAAP revenue up 137% to
$120.6 million 1 - Fourth quarter 2015 non-GAAP adjusted EBITDA increased 322% to
$61.3 million 1
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:
- Increased net product sales of Makena by 52% to
$251.6 million , compared with pro forma net product sales of$165.8 million 2 in 2014. This growth in sales was driven by a 56% increase in volume as more at-risk pregnant women were treated with Makena. - Made progress toward commercialization of a single-dose, preservative-free formulation of Makena. The company responded to questions contained in the FDA’s complete response letter in
November 2015 and anticipates an approval of its manufacturing supplement in the first quarter of 2016 with commercial launch in the second quarter of 2016. - Advanced the development of the next generation program for Makena with an auto-injector device for subcutaneous administration of Makena through a partnership with
Antares Pharma, Inc. , an experienced drug device company. - Expanded the maternal health portfolio through the acquisition of Cord Blood Registry (CBR), the world’s largest private newborn stem cell bank serving pregnant women and their families, and the purchase of an option to acquire worldwide rights to an orphan drug candidate being developed for severe preeclampsia.
- Returned Feraheme® (ferumoxytol) to growth in the second half of the year, increasing sales by 5% to
$88.5 million in 2015, compared with$84.4 million in 2014.3 - Initiated start-up activities for a head-to-head, Phase 3 clinical trial evaluating the safety of Feraheme compared to Injectafer® (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA). This study is intended to support an sNDA filing to broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment.
Fourth Quarter Ended
Financial Results (GAAP Basis)
Total revenues for the fourth quarter of 2015 were
Total costs and expenses for the fourth quarter of 2015 were
The company reported operating income of
Financial Results (Non-GAAP Basis)1,5
Non-GAAP revenues totaled
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
Financial Results (GAAP Basis)
Total revenues in 2015 were
Net income totaled
Financial Results (Non-GAAP Basis)1,5
Non-GAAP revenues totaled
Balance Sheet Highlights
As of
“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
2016 Goals
The company’s goals for 2016 include the following:
- Drive significant net product sales growth (+40%) over 2015
- Grow non-GAAP adjusted EBITDA to more than
$255 million - Continue to execute on the Makena next generation development program, including:
- Receiving a favorable decision from the
FDA in 1Q 2016 for the single-dose, preservative-free formulation of Makena with a 2Q 2016 commercial launch - Completing chemistry, manufacturing and controls (CMC) and pilot pharmacokinetics (PK) work to support the initiation of a bio-equivalence study for the Makena subcutaneous auto injecter by the end of 2016
- Receiving a favorable decision from the
- Enroll patients in a head-to-head Phase 3 clinical trial in 2016 evaluating the safety of Feraheme compared to Injectafer in adults with IDA
- Complete preclinical work and initiate clinical program for severe preeclampsia Velo option
- Further expand the company’s product portfolio through acquisitions or in-licensing of products or companies
2016 Financial Guidance6
$ in millions | 2016 Guidance | |||
Makena sales | $310 – $340 | |||
Feraheme and MuGard sales | $95 – $105 | |||
Non-GAAP CBR revenue | $115 -$125 | |||
Total revenue | $520 – $570 | |||
Non-GAAP adjusted EBITDA | $255- $285 | |||
Non-GAAP cash earnings | $195- $225 | |||
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
AMAG has presented certain non-GAAP financial measures, including non-GAAP revenue, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization), non-GAAP net income, or cash earnings, non-GAAP diluted net income, or cash earnings, per share, and non-GAAP weighted average diluted shares. These non-GAAP financial measures exclude certain amounts, revenue, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.
About AMAG
About Makena® (hydroxyprogesterone caproate injection)
Makena® is 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.
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.
Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or 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.
For additional product information, including full prescribing information, please visit www.makena.com.
About Feraheme® (ferumoxytol)
Feraheme received marketing approval from the
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)
CBR is the world’s largest private newborn stem cell company. Founded in 1992, CBR is entrusted by parents with storing more than 633,000 umbilical cord blood and cord tissue units. CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with reputable research institutions on
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding beliefs about AMAG being well-positioned for continued growth and future acquisitions; expectations for AMAG’s next generation development programs for Makena, including anticipated timing of potential approval and commercial launch of the single-dose preservative free Makena; expectations for AMAG’s Phase 3 clinical trial for the broader indication for Feraheme; AMAG’s expected 2015 fourth quarter and full year financial results, including revenues and year-end cash and investment balances and total debt; AMAG’s 2016 goals, including revenue growth, regulatory programs and portfolio expansion objectives; AMAG’s 2016 financial guidance, including revenues, adjusted EBITDA and cash earnings; AMAG’s ability to provide clear benefits, serve patients and improve people’s lives; and AMAG’s growth strategy, including the potential for future label and market expansion, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, 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.
— Tables Follow —
AMAG Pharmaceuticals, Inc. | |||||||||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||||||||
(unaudited, amounts in thousands, except for per share data) | |||||||||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||||||||
December 31, | December 31, | ||||||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||||||
Revenues: | |||||||||||||||||||||
Makena | $ | 67,356 | $ | 22,512 | $ | 251,615 | $ | 22,513 | |||||||||||||
Feraheme/MuGard | 23,476 | 24,469 | 90,201 | 87,485 | |||||||||||||||||
Cord Blood Registry | 16,955 | — | 24,132 | — | |||||||||||||||||
License fee, collaboration and other revenues | 948 | 6,272 | 52,328 | 14,386 | |||||||||||||||||
Total revenues | 108,735 | 53,253 | 418,276 | 124,384 | |||||||||||||||||
Operating costs and expenses: | |||||||||||||||||||||
Cost of product sales | 18,716 | 11,758 | 78,509 | 20,306 | |||||||||||||||||
Cost of services | 6,731 | — | 9,992 | — | |||||||||||||||||
Research and development expenses | 7,897 | 7,764 | 42,878 | 24,160 | |||||||||||||||||
Selling, general and administrative expenses | 50,255 | 27,521 | 160,309 | 72,254 | |||||||||||||||||
Acquisition-related costs | 80 | 7,561 | 11,232 | 9,478 | |||||||||||||||||
Restructuring expenses | 2,383 | 2,023 | 4,136 | 2,023 | |||||||||||||||||
Total costs and expenses | 86,062 | 56,627 | 307,056 | 128,221 | |||||||||||||||||
Operating income (loss) | 22,673 | (3,374 | ) | 111,220 | (3,837 | ) | |||||||||||||||
Other income (expense): | |||||||||||||||||||||
Interest expense | (18,457 | ) | (7,041 | ) | (53,251 | ) | (14,697 | ) | |||||||||||||
Loss on debt extinguishment | — | — | (10,449 | ) | — | ||||||||||||||||
Interest and dividend income, net | 545 | 166 | 1,512 | 975 | |||||||||||||||||
Other income (expense) | (8 | ) | 98 | (9,188 | ) | 217 | |||||||||||||||
Total other income (expense) | (17,920 | ) | (6,777 | ) | (71,376 | ) | (13,505 | ) | |||||||||||||
Net income (loss) before income taxes | 4,753 | (10,151 | ) | 39,844 | (17,342 | ) | |||||||||||||||
Income tax expense (benefit) | (2,448 | ) | (153,159 | ) | 7,065 | (153,159 | ) | ||||||||||||||
Net income (loss) | $ | 7,201 | $ | 143,008 | $ | 32,779 | $ | 135,817 | |||||||||||||
Net income (loss) per share | |||||||||||||||||||||
Basic | $ | 0.21 | $ | 5.98 | $ | 1.04 | $ | 6.06 | |||||||||||||
Diluted | $ | 0.20 | $ | 4.67 | $ | 0.93 | $ | 5.45 | |||||||||||||
Weighted average shares outstanding used to compute net income (loss) per share: | |||||||||||||||||||||
Basic | 34,712 | 23,911 | 31,471 | 22,416 | |||||||||||||||||
Diluted | 42,805 | 30,992 | 35,308 | 25,225 |
AMAG Pharmaceuticals, Inc. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(unaudited, amounts in thousands) | |||||||
December 31, 2015 | December 31, 2014 | ||||||
Assets: | |||||||
Cash and cash equivalents | $ | 228,705 | $ | 119,296 | |||
Investments | 237,626 | 24,890 | |||||
Accounts receivable, net | 85,678 | 38,172 | |||||
Inventories | 40,645 | 40,610 | |||||
Receivable from collaboration | 428 | 4,518 | |||||
Deferred tax assets | — | 32,094 | |||||
Prepaid and other current assets | 13,592 | 14,456 | |||||
Total current assets | 606,674 | 274,036 | |||||
Property, plant and equipment, net | 28,725 | 1,519 | |||||
Goodwill | 639,188 | 205,824 | |||||
Intangible assets, net | 1,196,771 | 887,908 | |||||
Restricted cash | 2,593 | 2,397 | |||||
Other long-term assets | 13,481 | 17,249 | |||||
Total assets | $ | 2,487,432 | $ | 1,388,933 | |||
Liabilities and stockholders’ equity: | |||||||
Accounts payable | $ | 4,906 | $ | 7,301 | |||
Accrued expenses | 106,363 | 80,093 | |||||
Current portion of long-term debt | 17,500 | 34,000 | |||||
Current portion of acquisition-related contingent consideration | 96,967 | 718 | |||||
Deferred revenues | 20,185 | 44,376 | |||||
Total current liabilities | 245,921 | 166,488 | |||||
Long-term liabilities: | |||||||
Long-term debt, net | 811,250 | 293,905 | |||||
Convertible 2.5% notes, net | 174,390 | 167,441 | |||||
Acquisition-related contingent consideration | 125,592 | 217,984 | |||||
Deferred tax liabilities | 189,145 | 77,619 | |||||
Deferred revenues | 5,093 | — | |||||
Other long-term liabilities | 3,777 | 5,543 | |||||
Total liabilities | 1,555,168 | 928,980 | |||||
Total stockholders’ equity | 932,264 | 459,953 | |||||
Total liabilities and stockholders’ equity | $ | 2,487,432 | $ | 1,388,933 |
AMAG Pharmaceuticals, Inc. | |||||||||||||||||||||||||||||||
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations | |||||||||||||||||||||||||||||||
(unaudited, amounts in thousands, except per share data) | |||||||||||||||||||||||||||||||
Three Months Ended | Three Months Ended | ||||||||||||||||||||||||||||||
December 31, 2015 | December 31, 2014 | ||||||||||||||||||||||||||||||
GAAP | Adjustments | Non-GAAP | GAAP | Adjustments | Non-GAAP | ||||||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||||||||
Makena | $ | 67,356 | $ | — | $ | 67,356 | $ | 22,512 | $ | — | $ | 22,512 | |||||||||||||||||||
Feraheme/MuGard | 23,476 | — | 23,476 | 24,469 | — | 24,469 | |||||||||||||||||||||||||
Cord Blood Registry | 16,955 | 11,815 | 7 | 28,770 | — | — | — | ||||||||||||||||||||||||
License fee, collaboration and other | 948 | — | 948 | 6,272 | (2,295 | ) | 8 | 3,977 | |||||||||||||||||||||||
Total revenues | 108,735 | 11,815 | 120,550 | 53,253 | (2,295 | ) | 50,958 | ||||||||||||||||||||||||
Operating costs and expenses: | |||||||||||||||||||||||||||||||
Cost of product sales | 18,716 | (14,938 | ) | 9 | 3,778 | 11,758 | (6,272 | ) | 9 | 5,486 | |||||||||||||||||||||
Cost of services | 6,731 | (1,348 | ) | 10 | 5,383 | — | — | — | |||||||||||||||||||||||
Research and development | 7,897 | (1,018 | ) | 11 | 6,879 | 7,764 | (338 | ) | 11 | 7,426 | |||||||||||||||||||||
Selling, general and administrative | 50,255 | (7,078 | ) | 12 | 43,177 | 27,521 | (4,021 | ) | 12 | 23,500 | |||||||||||||||||||||
Acquisition-related | 80 | (80 | ) | 13 | — | 7,561 | (7,561 | ) | 13 | — | |||||||||||||||||||||
Restructuring | 2,383 | (2,383 | ) | 14 | — | 2,023 | (2,023 | ) | 14 | — | |||||||||||||||||||||
Total costs and expenses | 86,062 | (26,845 | ) | 59,217 | 56,627 | (20,215 | ) | 36,412 | |||||||||||||||||||||||
Operating income (loss) / adjusted EBITDA | 22,673 | 38,660 | 61,333 | (3,374 | ) | 17,920 | 14,546 | ||||||||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||||||||||
Interest expense | (18,457 | ) | 3,098 | 15 | (15,359 | ) | (7,041 | ) | 2,436 | 15 | (4,605 | ) | |||||||||||||||||||
Loss on debt extinguishment | — | — | — | — | — | — | |||||||||||||||||||||||||
Interest and dividend income, net | 545 | — | 545 | 166 | — | 166 | |||||||||||||||||||||||||
Other income, net | (8 | ) | — | (8 | ) | 98 | (1 | ) | 97 | ||||||||||||||||||||||
Total other income (expense) | (17,920 | ) | 3,098 | (14,822 | ) | (6,777 | ) | 2,435 | (4,342 | ) | |||||||||||||||||||||
Net income (loss) before income taxes | 4,753 | 41,758 | 46,511 | (10,151 | ) | 20,355 | 10,204 | ||||||||||||||||||||||||
Income tax expense (benefit) | (2,448 | ) | 2,448 | 16 | — | (153,159 | ) | 153,159 | 16 | — | |||||||||||||||||||||
Net income (loss) / cash earnings | $ | 7,201 | $ | 39,310 | $ | 46,511 | $ | 143,008 | $ | (132,804 | ) | $ | 10,204 | ||||||||||||||||||
Net income (loss) / cash earnings per share | |||||||||||||||||||||||||||||||
Basic | $ | 0.21 | — | $ | 1.34 | $ | 5.98 | — | $ | 0.43 | |||||||||||||||||||||
Diluted | $ | 0.20 | — | $ | 1.12 | $ | 4.67 | — | $ | 0.33 | |||||||||||||||||||||
Weighted average shares outstanding | |||||||||||||||||||||||||||||||
Basic | 34,712 | — | 34,712 | 23,911 | — | 23,911 | |||||||||||||||||||||||||
Diluted | 42,805 | — | 41,614 | 30,992 | — | 30,992 | |||||||||||||||||||||||||
7 Adding back period write-down of deferred revenue from purchase accounting.
8 Eliminate non-cash revenue related to recognition of previously deferred revenue on Takeda agreement.
9 Eliminate the following: (i) non-cash step-up of inventory from purchase accounting; (ii) amortization expense related to intangible assets; (iii) depreciation expense; and (iv) stock-based compensation expense.
10 Eliminate the following: (i) depreciation expense; and (ii) certain non-recurring inventory reserves.
11 Eliminate the following: (i) non-cash step-up of inventory used in research and development from purchase accounting; (ii) depreciation expense; and (iii) stock-based compensation expense.
12 Eliminate the following: (i) non-cash adjustments related to contingent consideration; (ii) amortization expense related to intangible assets; (iii) certain transaction-related expenses; (iv) depreciation expense; and (v) stock-based compensation expense.
13 Eliminate non-recurring acquisition costs.
14 Eliminate non-recurring restructuring costs.
15 Eliminate non-cash interest expense; amortization of debt discount and other non-cash costs.
16 Eliminate non-cash income tax.
AMAG Pharmaceuticals, Inc. | |||||||||||||||||||||||||||||||
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations | |||||||||||||||||||||||||||||||
(unaudited, amounts in thousands, except per share data) | |||||||||||||||||||||||||||||||
Twelve Months Ended | Twelve Months Ended | ||||||||||||||||||||||||||||||
December 31, 2015 | December 31, 2014 | ||||||||||||||||||||||||||||||
GAAP | Adjustments | Non-GAAP | GAAP | Adjustments | Non-GAAP | ||||||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||||||||
Makena | $ | 251,615 | $ | — | $ | 251,615 | $ | 22,513 | $ | — | $ | 22,513 | |||||||||||||||||||
Feraheme/MuGard | 90,201 | — | 90,201 | 87,485 | — | 87,485 | |||||||||||||||||||||||||
Cord Blood Registry | 24,132 | 19,136 | 17 | 43,268 | — | — | — | ||||||||||||||||||||||||
License fee, collaboration and other revenues | 52,328 | (39,965 | ) | 18 | 12,363 | 14,386 | (8,217 | ) | 18 | 6,169 | |||||||||||||||||||||
Total revenues | 418,276 | (20,829 | ) | 397,447 | 124,384 | (8,217 | ) | 116,167 | |||||||||||||||||||||||
Operating costs and expenses: | |||||||||||||||||||||||||||||||
Cost of products sold | 78,509 | (64,536 | ) | 19 | 13,973 | 20,306 | (6,706 | ) | 19 | 13,600 | |||||||||||||||||||||
Cost of services | 9,992 | (1,563 | ) | 20 | 8,429 | — | — | — | |||||||||||||||||||||||
Research and development | 42,878 | (14,258 | ) | 21 | 28,620 | 24,160 | (1,662 | ) | 21 | 22,498 | |||||||||||||||||||||
Selling, general and administrative | 160,309 | (27,324 | ) | 22 | 132,985 | 72,254 | (6,534 | ) | 22 | 65,720 | |||||||||||||||||||||
Acquisition-related | 11,232 | (11,232 | ) | 23 | — | 9,478 | (9,478 | ) | 23 | — | |||||||||||||||||||||
Restructuring | 4,136 | (4,136 | ) | 24 | — | 2,023 | (2,023 | ) | 24 | — | |||||||||||||||||||||
Total costs and expenses | 307,056 | (123,049 | ) | 184,007 | 128,221 | (26,403 | ) | 101,818 | |||||||||||||||||||||||
Operating income (loss) / adjusted EBITDA | 111,220 | 102,220 | 213,440 | (3,837 | ) | 18,186 | 14,349 | ||||||||||||||||||||||||
Other income (expense): | — | ||||||||||||||||||||||||||||||
Interest expense | (53,251 | ) | 12,041 | 25 | (41,210 | ) | (14,697 | ) | 6,967 | 25 | (7,730 | ) | |||||||||||||||||||
Loss on debt extinguishment | (10,449 | ) | 10,449 | 26 | — | — | — | — | |||||||||||||||||||||||
Interest and dividend income, net | 1,512 | — | 1,512 | 975 | (17 | ) | 958 | ||||||||||||||||||||||||
Other income, net | (9,188 | ) | 9,185 | 26 | (3 | ) | 217 | (103 | ) | 114 | |||||||||||||||||||||
Total other income (expense) | (71,376 | ) | 31,675 | (39,701 | ) | (13,505 | ) | 6,847 | (6,658 | ) | |||||||||||||||||||||
Net income (loss) before income taxes | 39,844 | 133,895 | 173,739 | (17,342 | ) | 25,033 | 7,691 | ||||||||||||||||||||||||
Income tax expense (benefit) | 7,065 | (7,065 | ) | 27 | — | (153,159 | ) | 153,159 | 27 | — | |||||||||||||||||||||
Net income (loss) / cash earnings | $ | 32,779 | $ | 140,960 | $ | 173,739 | $ | 135,817 | $ | (128,126 | ) | $ | 7,691 | ||||||||||||||||||
Net income (loss) / cash earnings per share | |||||||||||||||||||||||||||||||
Basic | $ | 1.04 | — | $ | 5.52 | $ | 6.06 | — | $ | 0.34 | |||||||||||||||||||||
Diluted | $ | 0.93 | — | $ | 4.43 | $ | 5.45 | — | $ | 0.30 | |||||||||||||||||||||
Weighted average shares outstanding | |||||||||||||||||||||||||||||||
Basic | 31,471 | — | 31,471 | 22,416 | — | 22,416 | |||||||||||||||||||||||||
Diluted | 35,308 | — | 39,211 | 25,225 | — | 25,225 | |||||||||||||||||||||||||
17 Adding back period write-down of deferred revenue from purchase accounting.
18 Eliminate non-cash revenue related to recognition of previously deferred revenue on Takeda agreement.
19 Eliminate the following: (i) non-cash step-up of inventory from purchase accounting; (ii) amortization expense related to intangible assets; (iii) depreciation expense; and (iv) stock-based compensation expense.
20 Eliminate the following: (i) depreciation expense; and (ii) certain non-recurring inventory reserves.
21 Eliminate the following: (i) non-cash step-up of inventory used in research and development from purchase accounting; (ii) depreciation expense; and (iii) stock-based compensation expense.
22 Eliminating the following: (i) non-cash adjustments related to contingent consideration; (ii) amortization expense related to intangible assets; (iii) certain transaction-related expenses; (iv) depreciation expense; and (v) stock-based compensation expense.
23 Eliminate non-recurring acquisition costs.
24 Eliminate non-recurring restructuring costs.
25 Eliminate non-cash interest expense; amortization of debt discount and other non-cash costs.
26 Eliminate non-cash or other non-recurring expenses related to the
27 Eliminate non-cash income tax.
AMAG Pharmaceuticals, Inc. | ||||
Reconciliation of 2016 Financial Guidance of Non-GAAP Adjusted EBITDA | ||||
and Non-GAAP Cash Earnings | ||||
(unaudited, amounts in millions) | ||||
2016 | ||||
Financial | ||||
Guidance | ||||
GAAP net income | $11 – 41 | |||
Purchase accounting adjustments related to CBR deferred revenue | 17 | |||
Depreciation and amortization | 90 | |||
Interest expense, net | 72 | |||
Provision for income taxes | 20 | |||
EBITDA | $210 – 240 | |||
Non-cash inventory step-up adjustments | 5 | |||
Stock-based compensation | 27 | |||
Adjustments to contingent consideration | 12 | |||
Restructuring costs | 1 | |||
Non-GAAP Adjusted EBITDA | $255 – 285 | |||
Cash interest expense | (60 | ) | ||
Non-GAAP cash earnings | $195 – 225 |
AMAG Pharmaceuticals, Inc. | |||||||||
Share Count Reconciliation | |||||||||
(unaudited, amounts in millions) | |||||||||
Three Months Ended | Twelve Months Ended | ||||||||
December 31, 2015 | December 31, 2015 | ||||||||
Weighted average basic shares outstanding | 34.7 | 31.5 | |||||||
Employee equity incentive awards | 0.7 | 1.4 | |||||||
Convertible notes | 7.4 | — | 28 | ||||||
Warrants | — | 2.4 | |||||||
GAAP diluted shares outstanding | 42.8 | 35.3 | |||||||
Effect of bond hedge and warrants | (1.2 | ) | 29 | (3.5 | ) | 29 | |||
Effect of convertible notes | — | 7.4 | 30 | ||||||
Non-GAAP diluted shares outstanding | 41.6 | 39.2 | |||||||
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.
29 Reflects the impact of the non-GAAP benefit of the bond hedge and warrants.
30 Reflects the “in-the-money” convertible notes.
CONTACT:Linda Lennox Vice President, Investor Relations 617-498-2846