- First quarter 2016 non-GAAP product revenue increased 52% to
$117.6 million1
- Entered into new Makena® partnership with a leading provider of
home nursing services
Conference call scheduled for 8:00 a.m. ET
today
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG), a specialty
pharmaceutical company with a diverse portfolio of products in the
areas of maternal health, anemia management and cancer supportive
care, today reported unaudited consolidated financial results for
the first quarter ended March 31, 2016.
Most notably, the first quarter of 2016 included the approval of
a single-dose, preservative-free formulation of Makena®
(hydroxyprogesterone caproate injection). Prior to the commercial
availability of this new Makena formulation, healthcare providers
and patients who wanted a preservative-free formulation of
hydroxyprogesterone caproate had to use non-FDA-approved,
compounded versions. The company believes the commercial launch of
the single-dose, preservative-free formulation of Makena will
enable AMAG to capture significant additional share from the
compounded segment of the market. The company estimates that
compounding pharmacies currently hold approximately 37% of the
Makena-eligible market. Additionally, AMAG entered into an
agreement with a leading provider of home nursing services, which
will exclusively administer Makena to all indicated patients who
are eligible for their home health services.
“We are off to a strong start in 2016, achieving goals on our
next-generation program for Makena, including the commercial launch
of our new single-dose, preservative-free formulation, as well as
solidifying an important new strategic relationship to further
expand access to FDA-approved Makena,” said William Heiden, AMAG’s
chief executive officer. “First quarter 2016 sales of Makena
increased 17% over the prior year, and early data from the recent
launch of the new formulation of Makena, including April enrollment
data at the Makena Care Connection that is up approximately 50%
over March, suggests an acceleration in sales growth. We expect
these trends to continue through the remainder of the year and are
confirming our annual net product sales guidance for Makena.”
“CBR, our newborn stem cell preservation offering, as well as
our anemia management and cancer supportive care products,
performed in-line with our expectations and remain on track with
our 2016 sales guidance,” added Mr. Heiden.
1 See summaries of non-GAAP adjustments for the three
months ended March 31, 2016 and 2015 at the conclusion of this
press release.
First Quarter 2016 and Recent Business
Highlights:
- Increased net product sales of Makena to $65 million, compared
with $55.5 million in the first quarter of 2015. This growth in
sales was driven by a 16% increase in volume as more at-risk
pregnant women were treated with Makena. Net revenue per injection
was up 1% versus the first quarter of 2015.
- Received approval from the Food and Drug Administration (FDA)
in February 2016 for a single-dose, preservative-free formulation
of Makena and began commercial promotion in April 2016.
- Entered into a new agreement with a leading provider of home
nursing services, which had previously utilized compounded
hydroxyprogesterone caproate and now will exclusively provide
at-home administration of Makena.
- Continued development of the next-generation program to deliver
Makena subcutaneously via an auto-injector, with a range of
activities underway, such as CMC work and pilot pharmacokinetic
studies. The company currently anticipates filing the supplemental
New Drug Application (sNDA) in the second quarter of 2017 and
recently received confirmation from the FDA that the review time
will be six months from submission.
- Generated a record $24.2 million of Feraheme® (ferumoxytol)
sales in the first quarter of 2016, or 13% growth over the same
period in the prior year. Strong execution of the Feraheme business
strategies by the commercial team enabled the company to realize a
7% increase in volume.
- Began enrolling patients in 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.
- Increased cash, cash equivalents and investments by $13.9
million to $480 million, net of $12 million utilized to purchase
the company’s common stock and to repay debt.
- Strengthened the executive management team with the additions
of Nik Grund as chief commercial officer and Ted Myles as chief
financial officer.
First Quarter Ended March 31, 2016
(unaudited)Financial Results (GAAP Basis)Total
revenues for the first quarter of 2016 were $109.3 million,
compared with $89.5 million in the first quarter of 2015. Net
product sales of Makena were $65.0 million in the first quarter of
2016, compared with $55.5 million in the same period last year.
Sales of Feraheme and MuGard® totaled $24.5 million in the first
quarter of 2016, compared with $21.9 million in the first quarter
of 2015. Service revenue from Cord Blood Registry® (CBR), which
AMAG purchased in August 2015, totaled $19.5 million in the first
quarter of 2016.
Costs of product sales and services totaled $23.8 million in the
first quarter of 2016. In the first quarter of 2015, cost of
product sales totaled $21.0 million and did not include CBR cost of
services. Total operating expenses for the first quarter of 2016
were $78.0 million, compared with $39.7 million for the same period
in 2015. The increase in operating expenses was primarily due to
the acquisition of CBR in the third quarter of 2015, including the
non-cash amortization of intangible assets, and higher research and
development costs. These R&D costs included the initiation of
the company’s Phase 3 clinical trial to broaden the use of Feraheme
to include all adult IDA patients, costs to support our Makena
subcutaneous auto-injector and costs associated with preparing and
filing with the FDA for a second source manufacturer of the
single-dose, preservative-free formulation of Makena.
The company reported operating income of $7.4 million and a net
loss of $7.5 million, or ($0.22) per basic and diluted share, for
the first quarter of 2016, compared with operating income of $28.8
million and net income of $12.9 million, or $0.47 per basic share
and $0.39 per diluted share, for the same period in 2015.
Financial Results (Non-GAAP Basis)1,2Non-GAAP revenues totaled
$117.9 million in the first quarter of 2016, up from $83.1 million
in the first quarter of 2015. Non-GAAP CBR revenue totaled $28.1
million in the first quarter of 2016. The difference between GAAP
and non-GAAP revenue for CBR represents purchase accounting
adjustments related to deferred revenue. Non-GAAP revenue in 2015
excludes certain non-cash revenue related to the company’s ex-U.S.
marketing agreement with its former partner, Takeda Pharmaceutical
Company Limited.
Total costs and expenses on a non-GAAP basis totaled $70.4
million resulting in a gross margin of 92% and adjusted EBITDA
margin of 40% for the first quarter of 2016. This compares to costs
and expenses of $35.7 million in the same period of 2015, which
resulted in a gross margin of 96% and adjusted EBITDA margin of
57%. The decline in gross margin resulted from the acquisition of
CBR, which carries lower gross margins than the company’s
pharmaceutical products. Investments in research and development to
enhance the long-term revenue potential of Makena and Feraheme
contributed to the lower adjusted EBITDA margin in the first
quarter of 2016. Non-GAAP adjusted EBITDA for the first quarter of
2016 was $47.5 million, compared with $47.4 million for the same
period in 2015.
After deducting cash interest expense, the company generated
first quarter 2016 non-GAAP net income of $32.9 million, or $0.95
per non-GAAP basic share and $0.94 per non-GAAP diluted share. In
the first quarter of 2015, non-GAAP net income totaled $40.0
million, or $1.47 per non-GAAP basic share and $1.17 per non-GAAP
diluted share.
Balance Sheet HighlightsAs of March 31, 2016, the company’s cash
and investments totaled approximately $480 million and total debt
(principal amount outstanding) was approximately $1.04 billion.
"We are reiterating our full year 2016 guidance for revenue,
adjusted EBITDA and non-GAAP net income, including top-line revenue
growth of approximately 40%, which underscores the strong recent
trends for Makena and the overall underlying demand we are
generating across our portfolio of products,” said Frank Thomas,
president and chief operating officer. “During the quarter and
throughout 2016, we are investing in our products through R&D
to potentially expand our label for Feraheme and provide more
patient- and provider-friendly versions of Makena. We believe these
investments will enhance the long-term revenue potential of these
products.”
2 See share count reconciliation at the conclusion of this
press release.
2016 Financial Guidance3
|
|
|
|
|
$ in millions |
|
2016 Guidance |
|
|
Makena sales |
|
$310 -
$340 |
|
|
Feraheme and MuGard sales |
|
$95 -
$105 |
|
|
Non-GAAP CBR revenue |
|
$115
-$125 |
|
|
Non-GAAP total product
revenue |
|
$520 -
$570 |
|
|
Non-GAAP adjusted
EBITDA |
|
$255-
$285 |
|
|
Non-GAAP net
income |
|
$195-
$225 |
|
|
Conference Call and Webcast
Access AMAG Pharmaceuticals, Inc. will host a
conference call and webcast with slides today at 8:00 a.m. ET,
during which management will discuss the company’s financial and
operating results and recent developments. To access the conference
call via telephone, please dial (877) 412-6083 from the United
States or (702) 495-1202 for international access. A telephone
replay will be available from approximately 11:00 a.m. ET on May 3,
2016 through midnight on May 10, 2016. To access a replay of the
conference call, dial (855) 859-2056 from the United States or
(404) 537-3406 for international access. The pass code for the live
call and the replay is 90192659.
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 11:00 a.m.
ET on May 3, 2016 through midnight on June 3, 2016.
Use of Non-GAAP Financial
MeasuresAMAG 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, non-GAAP diluted net income 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.
3 See reconciliation of 2016 financial guidance of non-GAAP
CBR revenue, non-GAAP adjusted EBITDA and non-GAAP net income at
the conclusion of this press release.
About AMAGAMAG is a
biopharmaceutical company focused on bringing therapeutics to
market that provide clear benefits and help improve people’s lives.
Headquartered in Waltham, MA, AMAG possesses a diverse portfolio of
products to support the health of patients in the areas of maternal
health, anemia management and cancer supportive care. Through CBR®,
the company also helps 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 approximately 644,000 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.
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, AMAG’s belief that the single-dose, preservative-free
formulation of Makena will allow AMAG to capture significant market
share from the compounded segment of the market and the estimated
market share of the compounded segment; AMAG’s expectations
concerning the impact of strategic relationships on access to
Makena; expectations that the recent acceleration in Makena sales
growth will continue for the remainder of the year; AMAG’s belief
that product revenues, including CBR and Feraheme, remain on track
with 2016 sales guidance; expectations for AMAG’s next generation
development programs for Makena, including the FDA review period
for the auto-injector and the anticipated timing to file a sNDA for
the subcutaneous auto-injector; expectations for AMAG’s Phase 3
clinical trial for the broader indication for Feraheme; AMAG’s
expected 2016 first quarter financial results, including revenues
and year-end cash and investment balances and total debt; AMAG’s
2016 financial guidance, including revenues, adjusted EBITDA and
non-GAAP net income; and beliefs that AMAG’s investment in research
and development of our products will enhance their long-term
revenue potential, expand Feraheme’s label and provide more
patient- and provider-friendly versions of Makena 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, those 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, 2015 and subsequent filings with the SEC.
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
Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are
registered trademarks of CBR Systems, Inc.
AMAG
Pharmaceuticals, Inc. |
Condensed
Consolidated Statements of Operations |
(unaudited,
amounts in thousands, except for per share data) |
|
|
|
Three Months
Ended |
|
|
|
March 31, |
|
|
|
2016 |
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
Makena |
|
$ |
|
65,032 |
|
|
$ |
|
55,529 |
|
|
Feraheme/MuGard |
|
|
|
24,532 |
|
|
|
|
21,886 |
|
|
Cord Blood Registry |
|
|
|
19,520 |
|
|
|
|
— |
|
|
License fee, collaboration and
other revenues |
|
|
|
216 |
|
|
|
|
12,090 |
|
|
Total revenues |
|
|
|
109,300 |
|
|
|
|
89,505 |
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of product sales |
|
|
|
18,300 |
|
|
|
|
21,026 |
|
|
Cost of services |
|
|
|
5,526 |
|
|
|
|
— |
|
|
Research and development
expenses |
|
|
|
14,229 |
|
|
|
|
6,988 |
|
|
Selling, general and administrative
expenses |
|
|
|
63,175 |
|
|
|
|
32,112 |
|
|
Restructuring expenses |
|
|
|
622 |
|
|
|
|
571 |
|
|
Total costs and expenses |
|
|
|
101,852 |
|
|
|
|
60,697 |
|
|
Operating income |
|
|
|
7,448 |
|
|
|
|
28,808 |
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
Interest expense |
|
|
|
(18,443 |
) |
|
|
|
(10,367 |
) |
|
Interest and dividend income,
net |
|
|
|
708 |
|
|
|
|
71 |
|
|
Other income (expense) |
|
|
|
220 |
|
|
|
|
— |
|
|
Total other income
(expense) |
|
|
|
(17,515 |
) |
|
|
|
(10,296 |
) |
|
Net income (loss)
before income taxes |
|
|
|
(10,067 |
) |
|
|
|
18,512 |
|
|
Income tax expense
(benefit) |
|
|
|
(2,540 |
) |
|
|
|
5,608 |
|
|
Net income (loss) |
|
$ |
|
(7,527 |
) |
|
$ |
|
12,904 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share |
|
|
|
|
|
|
|
Basic |
|
$ |
|
(0.22 |
) |
|
$ |
|
0.47 |
|
|
Diluted |
|
$ |
|
(0.22 |
) |
|
$ |
|
0.39 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used to compute net income (loss) per share: |
|
|
|
|
|
|
|
Basic |
|
|
|
34,739 |
|
|
|
|
27,213 |
|
|
Diluted |
|
|
|
34,739 |
|
|
|
|
38,245 |
|
|
AMAG
Pharmaceuticals, Inc. |
Condensed
Consolidated Balance Sheets |
(unaudited,
amounts in thousands) |
|
|
|
March 31, 2016 |
|
December 31,
2015 |
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
203,389 |
|
$ |
228,705 |
|
Investments |
|
|
276,816 |
|
|
237,626 |
|
Accounts receivable, net |
|
|
82,754 |
|
|
85,678 |
|
Inventories |
|
|
42,002 |
|
|
40,645 |
|
Receivable from collaboration |
|
|
183 |
|
|
428 |
|
Prepaid and other current
assets |
|
|
17,089 |
|
|
13,592 |
|
Total current assets |
|
|
622,233 |
|
|
606,674 |
|
Property, plant and
equipment, net |
|
|
27,937 |
|
|
28,725 |
|
Goodwill |
|
|
639,484 |
|
|
639,188 |
|
Intangible assets,
net |
|
|
1,180,124 |
|
|
1,196,771 |
|
Restricted cash |
|
|
2,593 |
|
|
2,593 |
|
Other long-term
assets |
|
|
1,290 |
|
|
2,259 |
|
Total assets |
|
$ |
2,473,661 |
|
$ |
2,476,210 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,427 |
|
$ |
4,906 |
|
Accrued expenses |
|
|
101,895 |
|
|
106,363 |
|
Current portion of long-term
debt |
|
|
17,500 |
|
|
17,500 |
|
Current portion of
acquisition-related contingent consideration |
|
|
98,436 |
|
|
96,967 |
|
Deferred revenues |
|
|
27,336 |
|
|
20,185 |
|
Total current liabilities |
|
|
248,594 |
|
|
245,921 |
|
Long-term
liabilities: |
|
|
|
|
|
|
|
Long-term debt, net |
|
|
800,158 |
|
|
803,669 |
|
Convertible 2.5% notes, net |
|
|
172,822 |
|
|
170,749 |
|
Acquisition-related contingent
consideration |
|
|
129,114 |
|
|
125,592 |
|
Deferred tax liabilities |
|
|
188,634 |
|
|
189,145 |
|
Deferred revenues |
|
|
7,659 |
|
|
5,093 |
|
Other long-term liabilities |
|
|
3,708 |
|
|
3,777 |
|
Total liabilities |
|
|
1,550,689 |
|
|
1,543,946 |
|
Total stockholders’
equity |
|
|
922,972 |
|
|
932,264 |
|
Total liabilities and stockholders’
equity |
|
$ |
2,473,661 |
|
$ |
2,476,210 |
|
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 |
|
|
|
March 31, 2016 |
|
March 31, 2015 |
|
|
|
GAAP |
|
Adjustments |
|
Non-GAAP |
|
GAAP |
|
Adjustments |
|
Non-GAAP |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Makena |
|
$ |
|
65,032 |
|
|
$ |
|
— |
|
|
$ |
|
65,032 |
|
|
$ |
|
55,529 |
|
|
$ |
|
— |
|
|
$ |
|
55,529 |
|
|
Feraheme/MuGard |
|
|
|
24,532 |
|
|
|
|
— |
|
|
|
|
24,532 |
|
|
|
|
21,886 |
|
|
|
|
— |
|
|
|
|
21,886 |
|
|
Cord Blood Registry |
|
|
|
19,520 |
|
|
|
|
8,561 |
|
4 |
|
|
28,081 |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
License fee, collaboration and
other |
|
|
|
216 |
|
|
|
|
— |
|
|
|
|
216 |
|
|
|
|
12,090 |
|
|
|
|
(6,402 |
) |
5 |
|
|
5,688 |
|
|
Total revenues |
|
|
|
109,300 |
|
|
|
|
8,561 |
|
|
|
|
117,861 |
|
|
|
|
89,505 |
|
|
|
|
(6,402 |
) |
|
|
|
83,103 |
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
|
18,300 |
|
|
|
|
(14,609 |
) |
6 |
|
|
3,691 |
|
|
|
|
21,026 |
|
|
|
|
(17,740 |
) |
6 |
|
|
3,286 |
|
|
Cost of services |
|
|
|
5,526 |
|
|
|
|
(360 |
) |
7 |
|
|
5,166 |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
Research and development |
|
|
|
14,229 |
|
|
|
|
(774 |
) |
8 |
|
|
13,455 |
|
|
|
|
6,988 |
|
|
|
|
(493 |
) |
8 |
|
|
6,495 |
|
|
Selling, general and
administrative |
|
|
|
63,175 |
|
|
|
|
(15,120 |
) |
9 |
|
|
48,055 |
|
|
|
|
32,112 |
|
|
|
|
(6,186 |
) |
9 |
|
|
25,926 |
|
|
Restructuring |
|
|
|
622 |
|
|
|
|
(622 |
) |
10 |
|
|
— |
|
|
|
|
571 |
|
|
|
|
(571 |
) |
10 |
|
|
— |
|
|
Total costs and expenses |
|
|
|
101,852 |
|
|
|
|
(31,485 |
) |
|
|
|
70,367 |
|
|
|
|
60,697 |
|
|
|
|
(24,990 |
) |
|
|
|
35,707 |
|
|
Operating income (loss)
/ adjusted EBITDA |
|
|
|
7,448 |
|
|
|
|
40,046 |
|
|
|
|
47,494 |
|
|
|
|
28,808 |
|
|
|
|
18,588 |
|
|
|
|
47,396 |
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
(18,443 |
) |
|
|
|
2,945 |
|
11 |
|
|
(15,498 |
) |
|
|
|
(10,367 |
) |
|
|
|
2,885 |
|
11 |
|
|
(7,482 |
) |
|
Interest and dividend income,
net |
|
|
|
708 |
|
|
|
|
— |
|
|
|
|
708 |
|
|
|
|
71 |
|
|
|
|
— |
|
|
|
|
71 |
|
|
Other income, net |
|
|
|
220 |
|
|
|
|
— |
|
|
|
|
220 |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
Total other income (expense) |
|
|
|
(17,515 |
) |
|
|
|
2,945 |
|
|
|
|
(14,570 |
) |
|
|
|
(10,296 |
) |
|
|
|
2,885 |
|
|
|
|
(7,411 |
) |
|
Net income (loss)
before income taxes |
|
|
|
(10,067 |
) |
|
|
|
42,991 |
|
|
|
|
32,924 |
|
|
|
|
18,512 |
|
|
|
|
21,473 |
|
|
|
|
39,985 |
|
|
Income tax expense (benefit) |
|
|
|
(2,540 |
) |
|
|
|
2,540 |
|
12 |
|
|
— |
|
|
|
|
5,608 |
|
|
|
|
(5,608 |
) |
12 |
|
|
— |
|
|
Net income (loss) |
|
$ |
|
(7,527 |
) |
|
$ |
|
40,451 |
|
|
$ |
|
32,924 |
|
|
$ |
|
12,904 |
|
|
$ |
|
27,081 |
|
|
$ |
|
39,985 |
|
|
Net income (loss) per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
|
(0.22 |
) |
|
|
|
— |
|
|
$ |
|
0.95 |
|
|
$ |
|
0.47 |
|
|
|
|
— |
|
|
$ |
|
1.47 |
|
|
Diluted |
|
$ |
|
(0.22 |
) |
|
|
|
— |
|
|
$ |
|
0.94 |
|
|
$ |
|
0.39 |
|
|
|
|
— |
|
|
$ |
|
1.17 |
|
|
Weighted average shares
outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
34,739 |
|
|
|
|
— |
|
|
|
|
34,739 |
|
|
|
|
27,213 |
|
|
|
|
— |
|
|
|
|
27,213 |
|
|
Diluted |
|
|
|
34,739 |
|
|
|
|
— |
|
|
|
|
35,123 |
|
|
|
|
38,245 |
|
|
|
|
— |
|
|
|
|
34,058 |
|
|
4 Adding back period write-down of deferred revenue from
purchase accounting.5 Eliminate non-cash revenue related to
recognition of previously deferred revenue on Takeda agreement.6
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.7 Eliminate depreciation
expense.8 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.9 Eliminate the
following: (i) non-cash adjustments related to contingent
consideration; (ii) amortization expense related to intangible
assets; (iii) depreciation expense; and (iv) stock-based
compensation expense.10 Eliminate non-recurring restructuring
costs.11 Eliminate non-cash interest expense.12 Eliminate non-cash
income tax.
AMAG
Pharmaceuticals, Inc. |
Reconciliation of
2016 Financial Guidance of Non-GAAP Adjusted EBITDA |
and Non-GAAP Net
Income |
(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 net income |
|
$195 - 225 |
|
AMAG
Pharmaceuticals, Inc. |
Share Count
Reconciliation |
(unaudited,
amounts in millions) |
|
|
|
Three Months Ended |
|
Three Months
Ended |
|
|
|
March 31, 2016 |
|
March 31, 2015 |
|
|
Weighted average basic shares
outstanding |
|
34.7 |
|
27.2 |
|
|
Employee equity incentive
awards |
|
— |
13 |
1.5 |
|
|
Convertible notes |
|
— |
13 |
7.4 |
|
|
Warrants |
|
— |
13 |
2.1 |
|
|
GAAP
diluted shares outstanding |
|
34.7 |
|
38.2 |
|
|
Employee equity incentive
awards |
|
0.4 |
14 |
— |
|
|
Effect of bond hedge and
warrants |
|
— |
|
(4.1 |
) |
15 |
Non-GAAP diluted shares
outstanding |
|
35.1 |
|
34.1 |
|
|
13 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.14 Reflects
the Non-GAAP dilutive impact of the employee equity incentive
awards.15 Reflects the impact of the non-GAAP benefit of the bond
hedge and warrants.
CONTACT:
AMAG Pharmaceuticals, Inc.
Linda Lennox
Vice President, Investor Relations
617-498-2846
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