2016 GAAP revenue increased 27% over 2015
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited
consolidated financial results for the fourth quarter and full year
ended December 31, 2016.
Total GAAP revenue for the full year of 2016 increased
approximately 27% to $532.1 million, primarily driven by record
sales for both Makena® (hydroxyprogesterone caproate injection) and
Feraheme® (ferumoxytol) and the recognition of a full year of
service revenues from Cord Blood Registry® (CBR), which AMAG
acquired in August 2015. The company reported operating income of
$78.9 million in 2016. Non-GAAP adjusted EBITDA increased
approximately 24% to $265.7 million in 2016.1
“We drove significant top- and bottom-line growth in 2016,
building an even stronger base to grow and expand upon in 2017,”
said William Heiden, AMAG’s chief executive officer. “We achieved
our 2016 financial goals with strong performance across each of our
products, generated significant cash flows, and advanced our
next-generation development programs. In addition to the revenue
growth announced today from our current marketed product portfolio,
we recently expanded our women's health portfolio, acquiring rights
to RekyndaTM and IntrarosaTM, two important products with long-term
growth potential. In 2017, we expect to continue to drive growth
across our portfolio, execute well on upcoming new product
launches, and continue to expand our product portfolio through
additional business development transactions."
2016 Highlights:
Makena
- Successfully launched single-dose, preservative-free
formulation and strengthened an important relationship with a large
home health services provider
- Increased GAAP net sales by 33% to $334.1 million
- Successfully completed pharmacokinetic (PK) study comparing
bioavailability between subcutaneous and intramuscular (IM)
injections
Feraheme
- Completed enrollment in 2,000 patient, Phase 3 clinical trial
evaluating the safety of Feraheme compared to Injectafer® (ferric
carboxymaltose injection) in adults with iron deficiency anemia
(IDA)
- Accelerated potential approval time line for IDA label
expansion by approximately six months through rapid enrollment of
Phase 3 clinical study
- Maintained market share in competitive and growing intravenous
iron market
CBR
- Successfully implemented pricing strategy that increased
revenue per consumer by 8.5% over 2015
- Added more than 40,000 stored units of cord blood and cord
tissue
- Began implementation of enhanced messaging to capitalize on
generational shift
Financial
- Achieved record net sales of Makena and Feraheme
- Generated GAAP operating income of $78.9 million and non-GAAP
adjusted EBITDA of $265.7 million1
- Ended 2016 with $579.1 million of cash and investments, an
increase of $112.8 million, net of debt principal payments, stock
repurchases and a $100 million milestone payment to former
shareholders of Lumara Health, which AMAG acquired in 2014
Recent 2017 Business Highlights:
- Expanded portfolio into women’s health segment through two
recently-executed license agreements:- Rekynda, an
investigational product designed for on-demand treatment of
hypoactive sexual desire disorder (HSDD) that successfully met its
co-primary endpoints in two Phase 3 clinical trials, which closed
in February 2017- Intrarosa, the only FDA-approved, vaginally
administered, daily, non-estrogen product for the treatment of
moderate-to-severe dyspareunia (pain during intercourse), a common
symptom of vulvar and vaginal atrophy, due to menopause, which we
anticipate will close in the first half of 2017
- Announced topline PK data for Makena subcutaneous auto-injector
program and confirmed plans to submit sNDA in the second quarter of
2017, with an anticipated FDA decision and product launch in the
fourth quarter of 2017
Fourth Quarter Financial Results Ended December 31, 2016
(unaudited)GAAP Fourth Quarter Financial ResultsTotal GAAP
revenues for the fourth quarter of 2016 were $151.6 million,
compared with $108.7 million for the same period in 2015. In the
fourth quarter of 2016, sales of Makena increased 44% to $97.2
million, compared with $67.4 million in the same period last year;
sales of Feraheme and MuGard increased 13% to $26.6 million,
compared with $23.5 million in the same period last year; and
service revenue from CBR increased 64% to $27.7 million, compared
with $17.0 million in the same period last year. The growth in CBR
service revenue was positively impacted by a purchase accounting
adjustment to deferred revenue, which reduced the GAAP revenue
recorded in 2015.
Total costs and expenses, including costs of product sales and
services, totaled $137.0 million for the fourth quarter of 2016,
compared with $86.1 million for the same period in 2015. The
increase in total costs and expenses in the fourth quarter of 2016
was related to (i) higher cost of products sold due to an increase
in amortization expense recorded for the Makena intangible asset,
(ii) an impairment charge of a $3.7 million related to the CBR
tradename intangible asset (iii) higher R&D expenses associated
with the company's Makena and Feraheme next-generation development
programs, and (iv) higher expenses in selling, general and
administrative primarily due to an increase in the Makena
contingent consideration expense to reflect the estimated fair
value of future milestone payments.
Higher costs and expenses in the fourth quarter 2016 resulted in
a decrease in operating income, as compared to the prior year
period, of $8.1 million to $14.6 million. The company reported a
net loss of $10.6 million, or $0.31 per basic and diluted share for
the fourth quarter of 2016, compared with net income of $7.2
million, or $0.21 per basic share and $0.20 per diluted share, for
the same period in 2015.
Non-GAAP Fourth Quarter Financial Results1Non-GAAP revenue
totaled $153.0 million in the fourth quarter of 2016, up from
$120.6 million in same period last year. Non-GAAP CBR service
revenue totaled $29.1 million in the fourth quarter of 2016,
compared with $28.8 million in the fourth quarter of 2015. The
difference between GAAP and non-GAAP revenue for CBR represents
purchase accounting adjustments related to deferred revenue.
Total costs and expenses on a non-GAAP basis totaled $75.6
million, resulting in an adjusted EBITDA margin of 51% in the
fourth quarter of 2016. This compares to costs and expenses of
$59.2 million, resulting in an adjusted EBITDA margin of 51% in the
same period of 2015. Non-GAAP adjusted EBITDA totaled $77.4 million
in the fourth quarter of 2016, an increase of 26% from the $61.3
million recorded in the fourth quarter of 2015.
Full Year Financial Results Ended December 31, 2016
(unaudited)GAAP Full Year Financial ResultsTotal GAAP
revenues in 2016 increased 27% to $532.1 million, compared with
$418.3 million in 2015. This increase is primarily related to
record annual net sales of Makena and the recognition of a full
year of service revenues from CBR, partially offset by the
recognition of $52.3 million of collaboration revenue in 2015
related to the termination of the company’s ex-US ferumoxytol
marketing agreement. In 2016, net sales of Makena increased 33% to
$334.1 million, compared with $251.6 million in 2015; sales of
Feraheme and MuGard increased 9% to $98.1 million, compared with
$90.2 million in 2015; and service revenues from CBR, which AMAG
acquired in August 2015, were $99.6 million, compared with $24.1
million in 2015. The results for CBR were included from the date of
closing of the acquisition by AMAG in August 2015.
Total costs and expenses, including costs of product sales and
services, totaled $453.2 million in 2016, compared with $307.1
million in 2015. The increase in total costs and expenses in 2016
was primarily related to (i) higher expenses to account for a full
year of CBR ownership, (ii) higher amortization expense of the
Makena intangible asset, (iii) impairment charges recorded in 2016
of $15.7 million and $3.7 million related to MuGard and CBR
intangible assets, respectively, (iv) higher R&D expenses
related to the company's Makena and Feraheme next generation
development programs, and (v) an increase in the Makena contingent
consideration expense to reflect the estimated value of future
milestone payments.
Higher costs and expenses in 2016 resulted in a $32.4 million
decrease in operating income to $78.9 million, compared with $111.2
million in 2015. The company reported a net loss of $2.5 million,
or $0.07 per basic and diluted share in 2016. This compares with
net income of $32.8 million, or $1.04 per basic share and $0.93 per
diluted share, in 2015.
Non-GAAP Full Year Financial Results1Non-GAAP revenues increased
38% to $549.1 million in 2016, compared with $397.4 million in
2015. Non-GAAP CBR service revenue totaled $116.6 million in 2016,
compared with non-GAAP CBR service revenue of $43.3 million in
2015. Non-GAAP, pro forma CBR service revenue totaled $118.6
million in 2015, as if AMAG had acquired CBR at the beginning of
the period.
Total costs and expenses on a non-GAAP basis totaled $283.4
million, resulting in an adjusted EBITDA margin of 48% in 2016.
This compares to costs and expenses of $184.0 million in 2015,
resulting in an adjusted EBITDA margin of 54%. Non-GAAP adjusted
EBITDA totaled $265.7 million in 2016, compared with $213.4 million
in 2015.
Balance Sheet HighlightsAs of December 31, 2016, the
company’s cash, cash equivalents and investments increased by
$112.8 million to approximately $579.1 million, net of $20.0
million utilized to repurchase the company’s common stock, $17.5
million to repay debt and a $100.0 million milestone payment to
former Lumara Health shareholders, which was payable when Makena
annual net sales reached $300 million.
"We are pleased to confirm today that we achieved our key
financial goals in 2016. Specifically, we reported adjusted EBITDA
of $265.7 million, even after accelerating approximately $10
million of R&D costs from 2017 into 2016 due to the
faster-than-expected enrollment in our Feraheme IDA trial," said
Ted Myles, AMAG's chief financial officer. "Our demonstrated
ability to execute against our plan gives us confidence as we enter
2017 with another set of aggressive growth targets. The licensing
transaction that we announced this morning will impact our 2017
guidance, and we'll update the market after we close this
transaction and have additional visibility on launch timing, costs
and overall plans. Meanwhile, our strong cash position and our
ability to generate cash through operations allows us to pursue
additional portfolio expansion opportunities."
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 2016 financial results and recent developments, including its
exclusive U.S. license agreement for Intrarosa, which was announced
today in a separate news release.
Dial-in NumberU.S./Canada Dial-in Number: (877)
412-6083International Dial-in Number: (702) 495-1202Conference ID:
65936323
Replay Dial-in Number: (855) 859-2056Replay International
Dial-in Number: (404) 537-3406Conference ID: 65936323
A telephone replay will be available from approximately 11:00
a.m. ET on February 14, 2017 through midnight on February 21,
2017.
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, non-GAAP costs and expenses, non-GAAP adjusted EBITDA
(earnings before income taxes, depreciation and amortization) and
adjusted EBITDA margin. 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 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 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 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 FDA on June 30, 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 six issued patents covering the composition and dosage form
of the product. Each issued patent is 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. 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 670,000
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 RekyndaTM (bremelanotide)Rekynda
(bremelanotide), an investigational product, is thought to possess
a novel mechanism of action, activating endogenous melanocortin
pathways involved in sexual desire and response.
The two Phase 3 studies for HSDD in pre-menopausal women
consisted of double-blind placebo-controlled, randomized parallel
group studies comparing a subcutaneous dose of 1.75 mg of Rekynda
delivered via an auto-injector pen to placebo. 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, Rekynda met the pre-specified co-primary efficacy
endpoints of 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 12 months. Nearly 80% of patients elected to
remain in the open-label portion of the study, and all of these
patients will continue to receive Rekynda.
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.
Rekynda has no known alcohol interactions.
About IntrarosaTM (Prasterone)Intrarosa is the
only FDA-approved, vaginally administered, daily non-estrogen
steroid for the treatment of moderate-to-severe dyspareunia (pain
during intercourse), a symptom of vulvar and vaginal atrophy (VVA),
due to menopause. Intrarosa contains prasterone, also known as
dehydroepiandrosterone (DHEA). Prasterone is an inactive endogenous
steroid, which is converted locally into androgens and/or estrogens
to help restore the vaginal tissue as indicated by improvements in
the percentage of superficial cells, parabasal cells, and pH. The
mechanism of action is not fully established.
In two primary 12-week placebo-controlled efficacy trials, women
taking Intrarosa experienced a significant reduction in
dyspareunia, as well as significant improvements in the percentage
of vaginal superficial cells and parabasal cells, as well as
vaginal pH. In clinical trials, the most common adverse reactions
were vaginal discharge and abnormal pap smear. Patients with
current or prior history of breast cancer should talk to their
healthcare providers before using Intrarosa.
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, AMAG’s beliefs regarding the long-term growth
potential of Rekynda and Intrarosa; expectations that AMAG will
continue to drive growth across its portfolio, execute well on
upcoming new product launches and continue its expansion strategy
by entering into additional transactions, AMAG’s anticipated
expansion in women’s health through the licensing transaction with
Endoceutics, Inc., including the expected timing for the closing of
Intrarosa transaction, expectations regarding timing for the
submission of the Makena auto-injector sNDA (including expected
timing for an FDA decision on the sNDA and product launch, if
approved); expected 2016 fourth quarter and full year financial
results, including revenues and year end cash, cash equivalents and
investments balances; AMAG’s beliefs regarding its 2017 growth
targets and ability to pursue potential portfolio expansion
opportunities; and beliefs that newborn stem cells have the
potential to play a valuable role in the development of
regenerative medicine 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, (1) the
possibility that the closing conditions set forth in the Intrarosa
license agreement, including, those related to antitrust clearance,
will not be met and that the parties will be unable to consummate
the proposed transactions; (2) the possibility that AMAG will not
realize the expected benefits of the Intrarosa transaction,
including the anticipated market opportunity and the ability of its
current or expanded sales force to successfully commercialize
Intrarosa; (3) the possibility that significant safety or drug
interaction problems could arise with respect to Intrarosa; (4) the
ability of AMAG to drive awareness of dyspareunia and the potential
benefits of Intrarosa; (5) uncertainties regarding the manufacture
of Intrarosa; (6) uncertainties relating to patents and proprietary
rights associated with Intrarosa in the United States; (7) that the
cost of the transaction to AMAG will be more than planned and/or
will not provide the intended positive financial results; (8) that
AMAG or Endoceutics will fail to fully perform their respective
obligations under the Intrarosa license agreement or the Intrarosa
supply agreement; (9) uncertainty regarding AMAG’s ability to
compete in the dyspareunia market in the United States; and (10)
other risks identified in AMAG’s Securities and Exchange Commission
(“SEC”) filings, including its Annual Report on Form 10-K for the
year ended December 31, 2015, its Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2016, June 30, 2016 and September
30, 2016 and subsequent filings with the SEC, including its Current
Reports on Form 8-K filed with the SEC on January 9, 2017 and
February 3, 2017, as well as in its upcoming Annual Report on Form
10-K for the year ended December 31, 2016. 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 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
Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are
registered trademarks of CBR Systems, Inc. RekyndaTM is a
trademark of Palatin Technologies, Inc. IntrarosaTM is a trademark
of Endoceutics, Inc.
1 See summaries of GAAP to non-GAAP adjustments 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 December 31, |
|
Twelve Months Ended December 31, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Revenues: |
|
|
|
|
|
|
|
|
Makena |
|
$ |
97,226 |
|
|
$ |
67,356 |
|
|
$ |
334,050 |
|
|
$ |
251,615 |
|
Feraheme/MuGard |
|
26,619 |
|
|
23,476 |
|
|
98,120 |
|
|
90,201 |
|
Cord
Blood Registry |
|
27,741 |
|
|
16,955 |
|
|
99,604 |
|
|
24,132 |
|
License
fee, collaboration and other revenues |
|
4 |
|
|
948 |
|
|
317 |
|
|
52,328 |
|
Total
revenues |
|
151,590 |
|
|
108,735 |
|
|
532,091 |
|
|
418,276 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
Cost of
product sales |
|
30,372 |
|
|
18,716 |
|
|
96,314 |
|
|
78,509 |
|
Cost of
services |
|
4,870 |
|
|
6,731 |
|
|
20,575 |
|
|
9,992 |
|
Research
and development expenses |
|
20,505 |
|
|
7,897 |
|
|
66,084 |
|
|
42,878 |
|
Selling,
general and administrative expenses |
|
77,556 |
|
|
50,255 |
|
|
249,870 |
|
|
160,309 |
|
Impairment of intangible assets |
|
3,700 |
|
|
— |
|
|
19,663 |
|
|
— |
|
Acquisition-related costs |
|
— |
|
|
80 |
|
|
— |
|
|
11,232 |
|
Restructuring expenses |
|
3 |
|
|
2,383 |
|
|
715 |
|
|
4,136 |
|
Total
costs and expenses |
|
137,006 |
|
|
86,062 |
|
|
453,221 |
|
|
307,056 |
|
Operating income |
|
14,584 |
|
|
22,673 |
|
|
78,870 |
|
|
111,220 |
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest
expense |
|
(18,151 |
) |
|
(18,457 |
) |
|
(73,153 |
) |
|
(53,251 |
) |
Loss on
debt extinguishment |
|
— |
|
|
— |
|
|
— |
|
|
(10,449 |
) |
Interest
and dividend income |
|
830 |
|
|
545 |
|
|
3,149 |
|
|
1,512 |
|
Other
income (expense) |
|
(7 |
) |
|
(8 |
) |
|
189 |
|
|
(9,188 |
) |
Total
other income (expense) |
|
(17,328 |
) |
|
(17,920 |
) |
|
(69,815 |
) |
|
(71,376 |
) |
Income (loss) before
income taxes |
|
(2,744 |
) |
|
4,753 |
|
|
9,055 |
|
|
39,844 |
|
Income tax expense
(benefit) |
|
7,814 |
|
|
(2,448 |
) |
|
11,538 |
|
|
7,065 |
|
Net income (loss) |
|
$ |
(10,558 |
) |
|
$ |
7,201 |
|
|
$ |
(2,483 |
) |
|
$ |
32,779 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.31 |
) |
|
$ |
0.21 |
|
|
$ |
(0.07 |
) |
|
$ |
1.04 |
|
Diluted |
|
$ |
(0.31 |
) |
|
$ |
0.20 |
|
|
$ |
(0.07 |
) |
|
$ |
0.93 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used to compute net income (loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
34,254 |
|
|
34,712 |
|
|
34,346 |
|
|
31,471 |
|
Diluted |
|
34,254 |
|
|
42,805 |
|
|
34,346 |
|
|
35,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets |
(unaudited, amounts in thousands) |
|
|
December 31, 2016 |
|
December 31, 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 |
|
Total
stockholders’ equity |
934,389 |
|
|
932,264 |
|
Total
liabilities and stockholders’ equity |
$ |
2,478,426 |
|
|
$ |
2,476,210 |
|
|
|
|
|
|
|
|
|
AMAG Pharmaceuticals, Inc. |
Reconciliation of Condensed Consolidated Statements of
Operations to Non-GAAP Statements of Operations |
Three Months Ended December 31, 2016 |
(unaudited, amounts in thousands) |
|
|
Revenue |
|
Cost ofproductsales |
|
Cost ofservices |
|
Research &development |
|
Selling,general
&administrative |
|
Intangibleassetimpairmentcharges |
|
Acquisition-related |
|
Restructuring |
|
OperatingIncome /AdjustedEBITDA |
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 Operations |
Three Months Ended December 31, 2015 |
(unaudited, amounts in thousands) |
|
|
Revenue |
|
Cost ofproductsales |
|
Cost ofservices |
|
Research &development |
|
Selling,general
&administrative |
|
Intangibleassetimpairmentcharges |
|
Acquisition-related |
|
Restructuring |
|
OperatingIncome /AdjustedEBITDA |
GAAP |
$ |
108,735 |
|
|
$ |
18,716 |
|
|
$ |
6,731 |
|
|
$ |
7,897 |
|
|
$ |
50,255 |
|
|
$ |
— |
|
|
$ |
80 |
|
|
$ |
2,383 |
|
|
$ |
22,673 |
|
Purchase accounting
adjustments related to CBR deferred revenue |
11,815 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Inventory reserve |
— |
|
|
— |
|
|
(992 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Depreciation and
intangible asset amortization |
— |
|
|
(14,008 |
) |
|
(356 |
) |
|
(23 |
) |
|
(2,557 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Non-cash inventory
step-up adjustments |
— |
|
|
(813 |
) |
|
— |
|
|
(74 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(117 |
) |
|
— |
|
|
(921 |
) |
|
(4,627 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Adjustments to
contingent consideration |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
253 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Transaction/Acquisition-related costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(147 |
) |
|
— |
|
|
(80 |
) |
|
— |
|
|
|
Restructuring
costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,383 |
) |
|
|
Non-GAAP
Adjusted |
$ |
120,550 |
|
|
$ |
3,778 |
|
|
$ |
5,383 |
|
|
$ |
6,879 |
|
|
$ |
43,177 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
61,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG Pharmaceuticals, Inc. |
Reconciliation of Condensed Consolidated Statements of
Operations to Non-GAAP Statements of Operations |
Twelve Months Ended December 31, 2016 |
(unaudited, amounts in thousands) |
|
|
Revenue |
|
Cost ofproductsales |
|
Cost ofservices |
|
Research &development |
|
Selling,general
&administrative |
|
Intangibleassetimpairmentcharges |
|
Acquisition-related |
|
Restructuring |
|
OperatingIncome /AdjustedEBITDA |
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 |
) |
|
— |
|
|
— |
|
|
|
Transaction/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 Condensed Consolidated Statements of
Operations to Non-GAAP Statements of Operations |
Twelve Months Ended December 31, 2015 |
(unaudited, amounts in thousands) |
|
|
Revenue |
|
Cost ofproductsales |
|
Cost ofservices |
|
Research &development |
|
Selling,general
&administrative |
|
Intangibleassetimpairmentcharges |
|
Acquisition-related |
|
Restructuring |
|
OperatingIncome /AdjustedEBITDA |
GAAP |
$ |
418,276 |
|
|
$ |
78,509 |
|
|
$ |
9,992 |
|
|
$ |
42,878 |
|
|
$ |
160,309 |
|
|
$ |
— |
|
|
$ |
11,232 |
|
|
$ |
4,136 |
|
|
$ |
111,220 |
|
Purchase accounting
adjustments related to CBR deferred revenue |
19,136 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Non-cash collaboration
revenue |
(39,965 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Inventory reserve |
— |
|
|
— |
|
|
(992 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Depreciation and
intangible asset amortization |
— |
|
|
(52,521 |
) |
|
(571 |
) |
|
(75 |
) |
|
(4,292 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Non-cash inventory
step-up adjustments |
— |
|
|
(11,644 |
) |
|
— |
|
|
(1,192 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(371 |
) |
|
— |
|
|
(2,991 |
) |
|
(13,874 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Adjustments to
contingent consideration |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(4,272 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Option rights to
license orphan drug |
— |
|
|
— |
|
|
— |
|
|
(10,000 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Impairment charges of
intangible assets |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
Transaction/Acquisition-related costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,548 |
) |
|
— |
|
|
(11,232 |
) |
|
— |
|
|
|
Restructuring
costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,338 |
) |
|
— |
|
|
— |
|
|
(4,136 |
) |
|
|
Non-GAAP
Adjusted |
$ |
397,447 |
|
|
$ |
13,973 |
|
|
$ |
8,429 |
|
|
$ |
28,620 |
|
|
$ |
132,985 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
213,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG Pharmaceuticals, Inc. |
Share Count Reconciliation |
(unaudited, amounts in millions) |
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
Weighted
average basic shares outstanding |
34.3 |
|
|
34.7 |
|
|
34.3 |
|
|
31.5 |
|
|
Employee
equity incentive awards |
— |
|
1 |
0.7 |
|
|
— |
|
1 |
1.4 |
|
|
Convertible notes |
— |
|
1 |
7.4 |
|
|
— |
|
1 |
— |
|
1 |
Warrants |
— |
|
1 |
— |
|
1 |
— |
|
1 |
2.4 |
|
|
GAAP diluted
shares outstanding |
34.3 |
|
|
42.8 |
|
|
34.3 |
|
|
35.3 |
|
|
Employee
equity incentive awards |
0.8 |
|
2 |
— |
|
|
0.5 |
|
2 |
— |
|
|
Convertible notes |
— |
|
|
— |
|
|
— |
|
|
7.4 |
|
2 |
Effect of
bond hedge and warrants |
— |
|
|
(1.2 |
) |
3 |
— |
|
|
(3.5 |
) |
3 |
Non-GAAP
diluted shares outstanding |
35.1 |
|
|
41.6 |
|
|
34.8 |
|
|
39.2 |
|
|
|
1 Employee
equity incentive awards, convertible notes and warrants 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. |
2 Reflects
the Non-GAAP dilutive impact of employee equity incentive awards
and convertible notes. |
3 Reflects
the impact of the non-GAAP benefit of the bond hedge and
warrants. |
|
CONTACT:
Linda Lennox
Vice President, Investor Relations
617-498-2846
AMAG Pharmaceuticals (NASDAQ:AMAG)
Historical Stock Chart
From Apr 2024 to May 2024
AMAG Pharmaceuticals (NASDAQ:AMAG)
Historical Stock Chart
From May 2023 to May 2024