2017 GAAP Revenue Increased 15%
Year-over-Year
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited
consolidated financial results for the fourth quarter and full year
ended December 31, 2017.
Total GAAP revenue for the full year of 2017 increased
approximately 15% to $609.9 million, driven by increased sales
growth across AMAG's portfolio, which includes Makena®
(hydroxyprogesterone caproate injection), Feraheme® (ferumoxytol
injection) and Cord Blood Registry (CBR), as well as the addition
of Intrarosa® (prasterone) to the company's portfolio and
subsequent launch in July 2017. The company reported a GAAP
operating loss of $293.3 million in 2017, due primarily to a third
quarter non-cash accounting charge, and non-GAAP adjusted EBITDA of
$230.1 million in 2017.1
“2017 was an exciting year for AMAG and we have had a strong
start to 2018," said William Heiden, president and chief executive
officer. "In early 2017, we expanded our women's health product
portfolio with the in-licensing of Intrarosa and bremelanotide. Our
commercial team performed across the board by driving revenue to a
record level, with growth coming from each of the key products in
our portfolio. Today we also announced strong earnings in a year
when we made significant investments in our new products, as well
as in next generation opportunities for Makena and Feraheme --
which resulted in two sNDA approvals by the FDA this month."
"We have been evolving AMAG into a more fully integrated
pharmaceutical company with strong development capabilities. These
recent wins from our clinical and regulatory teams, and another NDA
filing with the FDA anticipated this quarter, are a testament to
the progress that we have made. This new corporate competency,
combined with our track record for commercial excellence, positions
AMAG well for an exciting future as we continue to work toward
bringing new therapies to patients in need,” continued Mr.
Heiden.
2017 Highlights and Recent
Events:Financial
- Achieved record revenue of $609.9 million, with every key AMAG
product growing over 2016
- Reduced total debt by nearly 20% and extended maturities,
ending 2017 with cash and cash investments of $328.7 million
Business Development
- Expanded product portfolio with Intrarosa and bremelanotide and
established new 170-person women's health commercial team
Intrarosa
- Launched Intrarosa; drove broad awareness and access; over
5,000 HCPs have prescribed Intrarosa
- Phase 3 hypoactive sexual desire disorder (HSDD) study in
post-menopausal women initiated by AMAG's partner, Endoceutics
Makena
- Received FDA approval for subcutaneous auto-injector (February
14, 2018)
- Achieved record sales of $387.2 million, an increase of 16%
over 2016
Feraheme
- Received FDA approval for broad IDA label (February 2,
2018)
- Grew sales to $105.9 million, an increase of 9% over 2016
CBR
- Increased storage revenue by approximately $7.4 million, or 9%,
over 2016
- Grew new first-time enrollments by 4% over 2016
Bremelanotide
- Completed clinical work with partner, Palatin, for planned new
drug application (NDA) submission in the first quarter of 2018
Fourth Quarter Financial Results Ended December 31, 2017
(unaudited)GAAP Fourth Quarter Financial ResultsTotal GAAP
revenues for the fourth quarter of 2017 were $158.3 million,
compared with $151.6 million for the same period in 2016. In the
fourth quarter of 2017, sales of Makena increased to $100.4
million, compared with $97.2 million in the same period last year;
sales of Feraheme and MuGard were $26.6 million; and service
revenue from CBR increased to $29.8 million, compared with $27.7
million in the same period last year.
Total costs and expenses, including costs of product sales and
services, were $165.5 million in the fourth quarter of 2017,
compared with $137.0 million in the same period in 2016. This
increase was primarily related to a $33.9 million increase in
amortization expense for the Makena intramuscular intangible asset,
which contributed to an operating loss of $7.1 million, compared
with operating income of $14.6 million in the prior year period.
The company reported net income of $3.5 million, or $0.10 per basic
and diluted share, in the fourth quarter of 2017, compared with a
net loss of $10.6 million, or $(0.31) per basic and diluted share,
in the same period of 2016. Net income in the fourth quarter of
2017 was driven primarily by a decrease in the deferred tax
liability due to federal tax reform.
Non-GAAP Fourth Quarter Financial Results1Non-GAAP revenue
totaled $159.7 million in the fourth quarter of 2017, up from
$153.0 million in same period last year. Non-GAAP CBR service
revenue totaled $31.2 million in the fourth quarter of 2017,
compared with $29.1 million in the fourth quarter of 2016. The
difference between GAAP and non-GAAP revenue represents CBR
purchase accounting adjustments related to deferred revenue.
Total costs and expenses on a non-GAAP basis totaled $94.0
million, resulting in an adjusted EBITDA margin of 41% in the
fourth quarter of 2017. Non-GAAP adjusted EBITDA totaled $65.7
million in the fourth quarter of 2017, compared to $77.4 million
recorded in the fourth quarter of 2016. The decline in adjusted
EBITDA for the fourth quarter of 2017 was in line with the
company's expectations and previously stated plans to invest in the
commercial launch of Intrarosa while also advancing bremelanotide
as the company prepares to file the NDA in the first quarter of
2018.
Full Year Financial Results Ended December 31, 2017
(unaudited)GAAP Full Year Financial ResultsTotal GAAP
revenues in 2017 increased 15% to $609.9 million, compared with
$532.1 million in 2016. This increase was driven by record sales of
Makena in 2017 and increased sales of Feraheme and CBR, as well as
the commercial launch of Intrarosa in July 2017. In 2017, net sales
of Makena increased 16% to $387.2 million, compared with $334.1
million in 2016; sales of Feraheme and MuGard increased 9% to
$106.7 million, compared with $98.1 million in 2016; and service
revenues from CBR increased 15% to $114.2 million, compared with
$99.6 million in 2016.
Total costs and expenses on a GAAP basis, including costs of
product sales and services, totaled $903.2 million in 2017,
compared with $453.2 million in 2016. The increase in total costs
and expenses in 2017 was primarily due to (i) the third quarter
non-cash impairment charge related to the Makena intramuscular
intangible asset of $319.2 million, (ii) acquired in-process
research and development expense in 2017 of $65.8 million primarily
due to our license agreement with Palatin Technologies for the
rights to bremelanotide, and (iii) higher amortization expense of
the Makena intramuscular intangible asset, partially offset by a
reduction in our fair value estimate of contingent
consideration.
Higher costs and expenses in 2017 (including the third quarter
non-cash impairment charge) resulted in an operating loss of $293.3
million, compared to operating income of $78.9 million in 2016. The
company reported a net loss of $199.2 million, or $(5.71) per basic
and diluted share in 2017, compared with a net loss of $2.5
million, or $(0.07) per basic and diluted share in 2016.
Non-GAAP Full Year Financial Results2Non-GAAP revenues increased
12% to $615.4 million in 2017, compared with $549.1 million in
2016. Non-GAAP CBR service revenue totaled $119.7 million in 2017,
compared with non-GAAP CBR service revenue of $116.6 million in
2016.
Total costs and expenses on a non-GAAP basis totaled $385.3
million, resulting in adjusted EBITDA of $230.1 million in 2017.
This compares to costs and expenses of $283.4 million and adjusted
EBITDA of $265.7 million in 2016. The increase of approximately
$101.9 million in total costs and expenses in 2017, compared with
2016 was consistent with the company's stated plan to invest in its
expanding portfolio of products. The majority of the increase,
approximately $81.8 million, was substantially related to the
hiring of the Intrarosa commercial team and costs associated with
the product launch during the second half of 2017.
Balance Sheet HighlightsThe company ended 2017 with $328.7
million in cash and investments and total debt (principal amount
outstanding) of $816.4 million. In 2017, the company reduced its
overall indebtedness by nearly 20% and extended maturities through
a series of financing transactions that were completed in the
second quarter.
2018 Financial Guidance2The company affirms the
following financial guidance for 2018.
$ in millions |
|
Total revenue |
$500 - $560 |
GAAP operating loss |
($147) - ($117) |
Non GAAP adjusted EBITDA |
$100 - $130 |
“In 2017, we delivered strong top- and bottom-line results while
investing aggressively in the products that we expect will drive
future growth and shareholder value," said Ted Myles, executive
vice president and chief financial officer. "We also improved our
liability profile so that our balance sheet is better aligned with
our evolving business strategy. We have a solid plan for 2018
focused on executional excellence across our portfolio, and with
two FDA approvals this month, we are off to a great start."
Conference Call and Webcast AccessAMAG
Pharmaceuticals, Inc. will host a conference call and webcast today
at 8:00 a.m. ET to discuss the company's fourth quarter and full
year 2017 financial results and recent developments.
Dial-in NumberU.S./Canada Dial-in Number: (877)
412-6083International Dial-in Number: (702) 495-1202Conference ID:
5496159
Replay Dial-in Number: (855) 859-2056Replay International
Dial-in Number: (404) 537-3406Conference ID: 5496159
A telephone replay will be available from approximately 11:00
a.m. ET on February 27, 2018 through midnight on March 5, 2018.
The webcast with slides will be accessible through the Investors
section of AMAG’s website at www.amagpharma.com. A replay of the
webcast will be archived on the website for 30 days.
Use of Non-GAAP Financial MeasuresAMAG has
presented certain non-GAAP financial measures, including non-GAAP
revenue and non-GAAP adjusted EBITDA (earnings before income taxes,
depreciation and amortization). 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 at the conclusion of this press
release.
About AMAGAMAG is a biopharmaceutical company
focused on developing and delivering important therapeutics,
conducting clinical research in areas of unmet need and creating
education and support programs for the patients and families we
serve. Our currently marketed products support the health of
patients in the areas of maternal and women's health, anemia
management and cancer supportive care. Through CBR®, we also help
families to preserve newborn stem cells, which are used today in
transplant medicine for certain cancers and blood, immune and
metabolic disorders, and have the potential to play a valuable role
in the ongoing development of regenerative medicine. For additional
company information, please visit www.amagpharma.com.
About Intrarosa® (prasterone)Intrarosa is
a steroid indicated for the treatment of moderate to severe
dyspareunia, a symptom of vulvar and vaginal atrophy, due to
menopause. Intrarosa contains prasterone, a synthetic form of
dehydroepiandrosterone (DHEA), which is an inactive endogenous
steroid. Intrarosa is administered locally in the vagina, and is
converted by enzymes in the body into androgens and estrogens. The
mechanism of action is not fully established. In clinical studies,
Intrarosa demonstrated efficacy through improvement in percentage
of superficial cells and parabasal cells, pH and pain with
intercourse.
Intrarosa is contraindicated in women with undiagnosed abnormal
genital bleeding. Estrogen is a metabolite of prasterone. Use of
exogenous estrogen is contraindicated in women with a known or
suspected history of breast cancer. Intrarosa has not been studied
in women with a history of breast cancer.
In four 12-week randomized, placebo-controlled clinical trials,
the most common adverse reaction with an incidence ≥2 percent was
vaginal discharge. In one 52-week open-label clinical trial, the
most common adverse reactions with an incidence ≥2 percent were
vaginal discharge and abnormal pap smear. There were 11 cases of
abnormal pap smears.
Please see full Prescribing Information available at
www.intrarosa.com.
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. The most common
side effects reported with the Makena auto-injector use (and higher
than with the Makena intramuscular injection) was injection site
pain.
For additional product information, including full prescribing
information, please visit www.makena.com.
About Feraheme® (ferumoxytol)Feraheme received
marketing approval from the FDA in June
2009 for the treatment of IDA in adult CKD patients and was
commercially launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol is protected in the U.S. by seven issued patents
covering the composition and dosage form of the product. Six of the
issued patents are listed in the FDA’s Orange Book, the last of
which expires in June 2023.
Fatal and serious hypersensitivity reactions including
anaphylaxis have occurred in patients receiving Feraheme. Initial
symptoms may include hypotension, syncope, unresponsiveness,
cardiac/cardiorespiratory arrest. Hypersensitivity reactions have
occurred in patients in whom a previous Feraheme dose was
tolerated. Patients with a history of multiple drug allergies may
have a greater risk of anaphylaxis with parenteral iron
products. Feraheme is contraindicated in patients with known
hypersensitivity to Feraheme or any of its components, or a history
of allergic reaction to any intravenous iron product.
Feraheme may cause clinically significant hypotension.
Excessive therapy with parenteral iron can lead to excess storage
of iron and possible hemosiderosis. Administration of Feraheme may
transiently affect the diagnostic ability of magnetic resonance
imaging. The most common adverse reactions (≥ 2%) are
diarrhea, headache, nausea, dizziness, hypotension, constipation,
and peripheral edema.
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 approximately 700,000
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 FDA-regulated
clinical trials for conditions that have no cure today. For more
information, visit www.cordblood.com.
About BremelanotideBremelanotide, an
investigational product, is thought to possess a novel mechanism of
action, activating endogenous melanocortin pathways involved in
sexual desire and response.
The Phase 3 studies for hypoactive sexual desire disorder (HSDD)
in pre-menopausal women consisted of two double-blind
placebo-controlled, randomized parallel group studies comparing as
desired use of 1.75 mg of bremelanotide versus placebo, in each
case, delivered via a subcutaneous auto-injector. Each trial
consisted of more than 600 patients randomized in a 1:1 ratio to
either the treatment arm or placebo with a 24 week evaluation
period. In both clinical trials, bremelanotide met the
pre-specified co-primary efficacy endpoints of median improvement
in desire and decrease in distress associated with low sexual
desire as measured using validated patient-reported outcome
instruments.
Women in the trials had the option, after completion of the
trial, to continue in an ongoing open-label safety extension study
for an additional 52 weeks. Nearly 80% of patients who completed
the randomized portion of the study elected to remain in the
open-label portion of the study, and all of these patients received
bremelanotide.
In both Phase 2 and Phase 3 clinical trials, the most frequent
adverse events were nausea, flushing, and headache, which were
generally mild-to-moderate in severity.
Forward-Looking StatementsThis press release
contains forward-looking information about AMAG Pharmaceuticals,
Inc. within the meaning of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Any statements
contained herein which do not describe historical facts, including,
among others, statements regarding plans and expectations for
AMAG’s upcoming NDA filing; beliefs about corporate competency;
plans for the future, including to bring new therapies to patients
in need; AMAG’s 2018 financial guidance, including total revenue,
operating loss and adjusted EBITDA; beliefs regarding AMAG’s
efforts to drive future growth and shareholder value; beliefs that
AMAG’s balance sheet is better aligned with its evolving business
strategy; expectations as to the company’s 2018 plan and position
for executional excellence; and expectations regarding the impact
of recent FDA approvals and beliefs regarding AMAG’s development
capabilities 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 the company’s expectations as to its 2018 plans
will not be realized, expectations for the recently approved Makena
subcutaneous auto-injector and the Feraheme label expansion will
not be achievable, and that the entrance of generics to the Makena
intramuscular formulation could happen more quickly than
anticipated in light of the loss of exclusivity in February 2018,
and those other risks identified in AMAG’s filings with the U.S.
Securities and Exchange Commission (SEC), including its Annual
Report on Form 10-K for the year ended December 31, 2016 and
subsequent filings with the SEC, including its upcoming Annual
Report on Form 10-K for the year ended December 31, 2017. Any such
risks and uncertainties could materially and adversely affect
AMAG’s results of operations, its profitability and its cash flows,
which would, in turn, have a significant and adverse impact on
AMAG’s stock price. AMAG cautions you not to place undue reliance
on any forward-looking statements, which speak only as of the date
they are made.
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
AMAG Pharmaceuticals, Inc. MuGard® is a registered trademark of
Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG
Pharma USA, Inc. Cord Blood Registry® and CBR® are registered
trademarks of Cbr Systems, Inc. Intrarosa® is a registered
trademark of Endoceutics, Inc.
1 See summaries of GAAP to non-GAAP adjustments at conclusion of
this press release.
2 See reconciliation of 2018 GAAP to non-GAAP financial guidance
at 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 December 31, |
|
Year Ended December 31, |
|
|
2017 |
|
|
2016 |
|
2017 |
|
2016 |
Revenues: |
|
|
|
|
|
|
|
|
Makena |
|
$ |
100,388 |
|
|
$ |
97,226 |
|
|
$ |
387,158 |
|
|
$ |
334,050 |
|
Feraheme/MuGard |
|
26,612 |
|
|
26,619 |
|
|
106,671 |
|
|
98,120 |
|
Cord
Blood Registry |
|
29,813 |
|
|
27,741 |
|
|
114,177 |
|
|
99,604 |
|
Intrarosa |
|
1,455 |
|
|
— |
|
|
1,816 |
|
|
— |
|
License
fee, collaboration and other revenues |
|
70 |
|
|
4 |
|
|
124 |
|
|
317 |
|
Total
revenues |
|
158,338 |
|
|
151,590 |
|
|
609,946 |
|
|
532,091 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
Cost of
product sales |
|
70,587 |
|
|
30,372 |
|
|
161,349 |
|
|
96,314 |
|
Cost of
services |
|
5,688 |
|
|
4,870 |
|
|
21,817 |
|
|
20,575 |
|
Research
and development expenses |
|
11,996 |
|
|
20,505 |
|
|
75,017 |
|
|
66,084 |
|
Acquired
in-process research and development |
|
— |
|
|
— |
|
|
65,845 |
|
|
— |
|
Selling,
general and administrative expenses |
|
77,214 |
|
|
77,556 |
|
|
259,933 |
|
|
249,870 |
|
Impairment of intangible assets |
|
— |
|
|
3,700 |
|
|
319,246 |
|
|
19,663 |
|
Restructuring expenses |
|
— |
|
|
3 |
|
|
— |
|
|
715 |
|
Total
costs and expenses |
|
165,485 |
|
|
137,006 |
|
|
903,207 |
|
|
453,221 |
|
Operating (loss)
income |
|
(7,147 |
) |
|
14,584 |
|
|
(293,261 |
) |
|
78,870 |
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest
expense |
|
(15,978 |
) |
|
(18,151 |
) |
|
(68,382 |
) |
|
(73,153 |
) |
Loss on
debt extinguishment |
|
(1,096 |
) |
|
— |
|
|
(10,926 |
) |
|
— |
|
Interest
and dividend income |
|
628 |
|
|
830 |
|
|
2,810 |
|
|
3,149 |
|
Other
income (expense) |
|
(292 |
) |
|
(7 |
) |
|
(335 |
) |
|
189 |
|
Total
other income (expense) |
|
(16,738 |
) |
|
(17,328 |
) |
|
(76,833 |
) |
|
(69,815 |
) |
Income (loss) before
income taxes |
|
(23,885 |
) |
|
(2,744 |
) |
|
(370,094 |
) |
|
9,055 |
|
Income tax expense
(benefit) |
|
(27,345 |
) |
|
7,814 |
|
|
(170,866 |
) |
|
11,538 |
|
Net income (loss) |
|
$ |
3,460 |
|
|
$ |
(10,558 |
) |
|
$ |
(199,228 |
) |
|
$ |
(2,483 |
) |
|
|
|
|
|
|
|
|
|
Net income (loss) per
share |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.10 |
|
|
$ |
(0.31 |
) |
|
$ |
(5.71 |
) |
|
$ |
(0.07 |
) |
Diluted |
|
$ |
0.10 |
|
|
$ |
(0.31 |
) |
|
$ |
(5.71 |
) |
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used to compute net income (loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
34,783 |
|
|
34,254 |
|
|
34,907 |
|
|
34,346 |
|
Diluted |
|
34,879 |
|
|
34,254 |
|
|
34,907 |
|
|
34,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG
Pharmaceuticals, Inc.Condensed Consolidated
Balance Sheets(unaudited, amounts in
thousands)
|
December 31, 2017 |
|
December 31, 2016 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
192,114 |
|
|
$ |
274,305 |
|
Marketable securities |
136,593 |
|
|
304,781 |
|
Accounts
receivable, net |
103,501 |
|
|
92,375 |
|
Inventories |
37,356 |
|
|
37,258 |
|
Prepaid
and other current assets |
12,304 |
|
|
9,839 |
|
Total
current assets |
481,868 |
|
|
718,558 |
|
Property, plant and
equipment, net |
25,996 |
|
|
24,460 |
|
Goodwill |
639,484 |
|
|
639,484 |
|
Intangible assets,
net |
704,470 |
|
|
1,092,178 |
|
Restricted cash |
656 |
|
|
2,593 |
|
Other long-term
assets |
762 |
|
|
1,153 |
|
Total
assets |
$ |
1,853,236 |
|
|
$ |
2,478,426 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
10,335 |
|
|
$ |
3,684 |
|
Accrued
expenses |
175,490 |
|
|
156,008 |
|
Current
portion of long-term debt |
— |
|
|
21,166 |
|
Current
portion of acquisition-related contingent consideration |
49,399 |
|
|
97,068 |
|
Deferred
revenues |
42,494 |
|
|
34,951 |
|
Total
current liabilities |
277,718 |
|
|
312,877 |
|
Long-term
liabilities: |
|
|
|
Long-term
debt, net |
466,291 |
|
|
785,992 |
|
Convertible notes, net |
268,392 |
|
|
179,363 |
|
Acquisition-related contingent consideration |
686 |
|
|
50,927 |
|
Deferred
tax liabilities |
23,927 |
|
|
197,066 |
|
Deferred
revenues |
24,387 |
|
|
14,850 |
|
Other
long-term liabilities |
1,591 |
|
|
2,962 |
|
Total
liabilities |
1,062,992 |
|
|
1,544,037 |
|
Total
stockholders’ equity |
790,244 |
|
|
934,389 |
|
Total
liabilities and stockholders’ equity |
$ |
1,853,236 |
|
|
$ |
2,478,426 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended
December 31, 2017 (unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Cost of services |
|
Research & development |
|
Selling, general &
administrative |
|
Intangible asset impairment
charges |
|
Restructuring |
|
Operating Loss / Adjusted EBITDA |
GAAP |
$ |
158,338 |
|
|
$ |
70,587 |
|
|
$ |
5,688 |
|
|
$ |
11,996 |
|
|
$ |
77,214 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(7,147 |
) |
Purchase accounting
adjustments related to CBR deferred revenue |
1,373 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Depreciation and
intangible asset amortization |
— |
|
|
(60,818 |
) |
|
(398 |
) |
|
(63 |
) |
|
(4,399 |
) |
|
— |
|
|
— |
|
|
|
Non-cash inventory
step-up adjustments |
— |
|
|
(919 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(194 |
) |
|
— |
|
|
(575 |
) |
|
(4,646 |
) |
|
— |
|
|
— |
|
|
|
Adjustments to
contingent consideration |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
543 |
|
|
— |
|
|
— |
|
|
|
Non-GAAP
Adjusted |
$ |
159,711 |
|
|
$ |
8,656 |
|
|
$ |
5,290 |
|
|
$ |
11,358 |
|
|
$ |
68,712 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
65,695 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended
December 31, 2016 (unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Cost of services |
|
Research & development |
|
Selling, general &
administrative |
|
Intangible asset impairment
charges |
|
Restructuring |
|
Operating Income / Adjusted
EBITDA |
GAAP |
$ |
151,590 |
|
|
$ |
30,372 |
|
|
$ |
4,870 |
|
|
$ |
20,505 |
|
|
$ |
77,556 |
|
|
$ |
3,700 |
|
|
$ |
3 |
|
|
$ |
14,584 |
|
Purchase accounting
adjustments related to CBR deferred revenue |
1,378 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Depreciation and
intangible asset amortization |
— |
|
|
(23,554 |
) |
|
(371 |
) |
|
(48 |
) |
|
(5,067 |
) |
|
— |
|
|
— |
|
|
|
Non-cash inventory
step-up adjustments |
— |
|
|
(1,024 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(125 |
) |
|
— |
|
|
(893 |
) |
|
(4,719 |
) |
|
— |
|
|
— |
|
|
|
Adjustments to
contingent consideration |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(20,576 |
) |
|
— |
|
|
— |
|
|
|
Impairment charges of
intangible assets |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(3,700 |
) |
|
— |
|
|
|
Transaction/Acquisition-related costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,318 |
) |
|
— |
|
— |
|
— |
|
|
|
Restructuring
costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(3 |
) |
|
|
Non-GAAP
Adjusted |
$ |
152,968 |
|
|
$ |
5,669 |
|
|
$ |
4,499 |
|
|
$ |
19,564 |
|
|
$ |
45,876 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
77,360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsTwelve Months Ended
December 31, 2017 (unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Cost of services |
|
Research & development |
|
Selling, general &
administrative |
|
Intangible asset impairment
charges |
|
Restructuring |
|
Operating Loss / Adjusted EBITDA |
GAAP |
$ |
609,946 |
|
|
$ |
161,349 |
|
|
$ |
21,817 |
|
|
$ |
140,862 |
|
|
$ |
259,933 |
|
|
$ |
319,246 |
|
|
$ |
— |
|
|
$ |
(293,261 |
) |
Purchase accounting
adjustments related to CBR deferred revenue |
5,479 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Depreciation and
intangible asset amortization |
— |
|
|
(130,518 |
) |
|
(1,576 |
) |
|
(180 |
) |
|
(21,014 |
) |
|
— |
|
|
— |
|
|
|
Non-cash inventory
step-up adjustments |
— |
|
|
(2,146 |
) |
|
— |
|
|
(103 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(882 |
) |
|
(202 |
) |
|
(3,225 |
) |
|
(19,163 |
) |
|
— |
|
|
— |
|
|
|
Adjustments to
contingent consideration |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
47,686 |
|
|
— |
|
|
— |
|
|
|
Impairment charges of
intangible assets |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(319,246 |
) |
|
— |
|
|
|
Acquisition-related
costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,462 |
) |
|
— |
|
|
— |
|
|
|
Acquired IPR&D |
— |
|
|
— |
|
|
— |
|
|
(65,845 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Non-GAAP
Adjusted |
$ |
615,425 |
|
|
$ |
27,803 |
|
|
$ |
20,039 |
|
|
$ |
71,509 |
|
|
$ |
265,980 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
230,094 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsTwelve Months Ended
December 31, 2016 (unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Cost of services |
|
Research & development |
|
Selling, general &
administrative |
|
Intangible asset impairment
charges |
|
Restructuring |
|
Operating Income / Adjusted
EBITDA |
GAAP |
$ |
532,091 |
|
|
$ |
96,314 |
|
|
$ |
20,575 |
|
|
$ |
66,084 |
|
|
$ |
249,870 |
|
|
$ |
19,663 |
|
|
$ |
715 |
|
|
$ |
78,870 |
|
Purchase accounting
adjustments related to CBR deferred revenue |
16,977 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Depreciation and
intangible asset amortization |
— |
|
|
(72,463 |
) |
|
(1,435 |
) |
|
(145 |
) |
|
(20,100 |
) |
|
— |
|
|
— |
|
|
|
Non-cash inventory
step-up adjustments |
— |
|
|
(4,880 |
) |
|
— |
|
|
(861 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(511 |
) |
|
(9 |
) |
|
(3,476 |
) |
|
(18,547 |
) |
|
— |
|
|
— |
|
|
|
Adjustments to
contingent consideration |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(25,682 |
) |
|
— |
|
|
— |
|
|
|
Impairment charges of
intangible assets |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(19,663 |
) |
|
— |
|
|
|
Acquisition-related
costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,318 |
) |
|
— |
|
|
— |
|
|
|
Restructuring
costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(715 |
) |
|
|
Non-GAAP
Adjusted |
$ |
549,068 |
|
|
$ |
18,460 |
|
|
$ |
19,131 |
|
|
$ |
61,602 |
|
|
$ |
184,223 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
265,652 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG
Pharmaceuticals, Inc.Reconciliation of 2018
Financial Guidance of Non-GAAP Adjusted
EBITDA(Unaudited, amounts in
millions)
Operating
Loss |
($147) - ($117) |
Depreciation &
intangible asset amortization |
200 |
Stock-based
compensation |
23 |
Non-cash inventory step
up and adjustments to contingent consideration |
4 |
Acquired IPR&D |
20 |
Non-GAAP
adjusted EBITDA |
$100 - $130 |
|
|
|
|
AMAG
Pharmaceuticals, Inc.Share Count
Reconciliation(unaudited, amounts in
millions)
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
Weighted
average basic shares outstanding |
34.8 |
|
|
34.3 |
|
|
34.9 |
|
|
34.3 |
|
|
Employee
equity incentive awards |
0.1 |
|
|
— |
|
3 |
— |
|
3 |
— |
|
3 |
GAAP diluted
shares outstanding |
34.9 |
|
|
34.3 |
|
|
34.9 |
|
|
34.3 |
|
|
Employee
equity incentive awards |
— |
|
|
0.8 |
|
4 |
0.3 |
|
4 |
0.5 |
|
4 |
Non-GAAP
diluted shares outstanding |
34.9 |
|
|
35.1 |
|
|
35.2 |
|
|
34.8 |
|
|
3 Employee equity incentive awards would be anti-dilutive in
this period.4 Reflects the non-GAAP dilutive impact of
employee equity incentive awards.
CONTACT:Linda LennoxVice President, Investor
Relations617-498-2846
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