Achieved record Feraheme revenue growth and more
than 50% market share for Makena auto-injector
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited
consolidated financial results for the first quarter ended
March 31, 2019 and provided a business update.
Total revenue for the first quarter of 2019 was $75.8 million,
compared with $117.4 million in the same period last year. Makena®
(hydroxyprogesterone caproate injection) revenues were $31.3
million in the first quarter, compared with $90.0 million in the
same period last year. This decline was primarily due to the
mid-2018 entry of generic competition to the Makena intramuscular
(IM) product, as well as IM supply constraints in the quarter
(described below). Feraheme® (ferumoxytol injection) first quarter
2019 revenues increased to a record $40.0 million, or 59%, over the
same period last year. Intrarosa® (prasterone) realized significant
growth in net price as well as volume growth in the first quarter
of 2019, as compared to the prior year period.
The company reported an operating loss of $117.7 million in the
first quarter of 2019, compared with an operating loss of $50.8
million in the first quarter of 2018. Included in the loss in the
first quarter of 2019 was a $74.9 million accounting impact related
to the acquisition of Perosphere Pharmaceuticals Inc., which closed
in the quarter. Consistent with its strategic plan and 2019
financial guidance, the company reported negative adjusted EBITDA
of $26.6 million in the first quarter of 2019, compared with
positive adjusted EBITDA of $30.0 million in the first quarter of
2018.1
“While total Makena revenues in the first quarter were adversely
impacted by a number of non-recurring charges, we are encouraged by
the strong underlying demand for the subcutaneous auto-injector,
and the progress made to replace our previous primary supplier of
Makena IM with new inventory from two suppliers this second
quarter," said William Heiden, AMAG's president and chief executive
officer. "We're also proud of our Feraheme team and the continued
growth that product has realized. The significant cash flow from
these products helps fund the development of our novel pipeline
assets, which we believe are the future value drivers of the
company."
"In the first quarter, our development pipeline continued to
progress nicely. We are eagerly awaiting a decision on the upcoming
PDUFA date for VyleesiTM (bremelanotide) and the mid-year
initiation of the Phase 3a clinical studies for ciraparantag,"
continued Mr. Heiden. “We look forward to discussing more about
AMAG’s future at our Analyst Day that will be held on May 22 in New
York, which will include panels for AMAG-423, Vyleesi and
ciraparantag of key opinion leaders who will provide their expert
views on the opportunity for and value of these new product
candidates.”
First Quarter 2019 and Recent Business
Highlights:
- Promoted Tony Casciano to chief commercial officer; Mr.
Casciano led the successful launches of the Makena SC auto-injector
and the Feraheme broad label
- Achieved 59% growth in Feraheme net sales year-over-year
- Makena SC auto-injector achieved 40% volume growth and captured
54% market share of all FDA-approved hydroxyprogesterone caproate
prescription volume over the fourth quarter of 2018
- Improved first quarter 2019 Intrarosa gross-to-net price by
more than 30% over the fourth quarter of 2018; successfully
combined and cross trained the women's health and maternal health
sales forces into one team of approximately 125 sales
representatives
- Acquired Perosphere Pharmaceuticals, including ciraparantag, a
development-stage drug candidate to reverse the anticoagulant
effects of novel oral anticoagulants (NOACs) and low molecular
weight heparin (LMWH)
- Completed the study and submitted ambulatory blood pressure
data to the FDA and continued activities supporting the potential
launch of Vyleesi (PDUFA date: June 23, 2019)
- Data presentations:
- New and encore data related to Vyleesi for the treatment of
hypoactive sexual desire disorder (HSDD) at the International
Society for the Study of Women’s Sexual Health
(ISSWSH)/International Society for Sexual Medicine (ISSM) joint
meeting
- New data related to Vyleesi for the treatment of HSDD and
Feraheme related to iron deficiency anemia (IDA) resulting from
abnormal uterine bleeding at the American College of Obstetricians
and Gynecologists (ACOG) Annual Clinical and Scientific
Meeting
- Reaffirmed 2019 financial guidance
First Quarter Ended March 31, 2019
(unaudited)Total revenues for the first quarter of 2019
were $75.8 million, compared with $117.4 million in the first
quarter of 2018. First quarter 2019 net product sales of Makena
were $31.3 million, which were lower than the $90.0 million
reported in the first quarter of 2018, primarily due to the
mid-2018 entry of generic competition to the Makena IM product, as
well as IM supply constraints. Makena revenues in the first quarter
of 2019 were further impacted by a number of gross-to-net charges,
including: (i) $3.5 million of failure-to-supply penalties related
to a temporary authorized generic (AGx) IM out of stock situation
that occurred during the first quarter, (ii) approximately $5.0
million of increased Medicaid rebates related to the IM supply
constraints in the quarter and best price implications, and (iii)
$6.0 million change in estimate for Medicaid liability for prior
period sales of the Makena IM product. The company expects to
resolve its Makena IM supply constraints in the second quarter of
2019 and, therefore, believes charges (i) and (ii) described above
are non-recurring in nature. During the first quarter of 2019, the
company did not record any branded Makena IM revenues, and revenues
for the AGx were adversely impacted by IM supply constraints. Sales
of the Makena SC auto-injector totaled $37.8 million in the first
quarter of 2019, which is net of the $5.0 million additional
Medicaid rebates referenced above. Sales of Feraheme and MuGard®
increased 59% to $40.1 million in the first quarter of 2019,
compared with $25.2 million in the first quarter of 2018. Intrarosa
contributed $4.4 million in net sales during the first quarter of
2019, compared with $2.2 million in the same period last year.
Operating expenses, including cost of product sales, were
aligned with expectations, totaling $193.5 million in the first
quarter of 2019, compared with $168.2 million for the same period
in 2018. This increase was primarily due to: (i) the $74.9 million
acquired in-process research and development charge related to the
acquisition of Perosphere, (ii) a one-time restructuring charge of
$7.4 million related to combining the company's women's health and
maternal health sales forces, and (iii) higher research and
development costs of $7.3 million related to the company's ongoing
clinical development programs. These increases in operating
expenses were partially off-set by a $45.4 million reduction in
cost of product sales, driven primarily by lower intangible
amortization expense.
The company reported an operating loss from continuing
operations in the first quarter of 2019 of $117.7 million, compared
with an operating loss of $50.8 million for the same period last
year, largely due to the Perosphere acquisition described above.
The company reported a net loss from continuing operations of
$122.1 million, or $3.54 loss per basic and diluted share, for the
first quarter of 2019, compared with a net loss from continuing
operations of $58.1 million, or $1.70 loss per basic and diluted
share, for the same period in 2018. The net loss reported during
the first quarter on 2019 was favorably impacted by a reduction in
interest expense incurred, as compared to the prior year period.
This was the result of the company retiring $475 million in
high-yield bonds in the third quarter of 2018.
Non-GAAP adjusted EBITDA from continuing operations for the
first quarter of 2019 was ($26.6) million, compared with $30.0
million in the first quarter of 2018.
Balance Sheet HighlightsAs of March 31,
2019, the company’s cash and investments totaled $266.5 million,
and long-term total debt totaled $320.0 million (representing the
principal amounts outstanding of the 2022 convertible notes). Cash
used during the first quarter of 2019 included: (i) $70.8 million
related to the acquisition of Perosphere Pharmaceuticals, (ii)
$21.4 million for the repayment of the balance of the company's
2019 Convertible Note, and (iii) $13.7 million for the repurchase
of approximately 1.1 million shares of common stock.
Reaffirming 2019 Financial Guidance2The company
reaffirmed the following financial guidance for 2019.
($M) |
|
2019 Financial Guidance |
Total revenue |
|
$365 - $415 |
Operating loss3 |
|
($206) - ($176) |
Adjusted EBITDA |
|
($65) - ($35) |
"We're pleased with the market uptake of the Makena SC
auto-injector, which captured more than 50 percent share of
patients treated with FDA-approved hydroxyprogesterone caproate in
the first quarter, underscoring continued strong physician demand
of this differentiated product and the sustainability of the Makena
franchise," said Ted Myles, AMAG’s chief financial officer. "With
the expected return of Makena IM supply in the second quarter,
continued strong underlying demand for the SC auto-injector,
impressive performance from Feraheme, as well as encouraging
leading indicators from our Intrarosa direct-to-consumer campaign,
we are reiterating our full year guidance for 2019."
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 first quarter 2019
financial results, recent business highlights and 2019 outlook.
Dial-in NumberU.S./Canada dial-in number: (877)
412-6083International dial-in number: (702) 495-1202Conference ID:
6850648
Replay dial-in number: (855) 859-2056Replay International
dial-in number: (404) 537-3406Conference ID: 6850648
A telephone replay will be available from approximately 11:00
a.m. ET on May 7, 2019 through midnight on May 14, 2019. 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
costs and expenses and non-GAAP adjusted EBITDA (earnings before
income taxes, depreciation and amortization). These non-GAAP
financial measures exclude certain amounts, 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 pharmaceutical company
focused on bringing innovative products to patients with unmet
medical needs. The company does this by leveraging our development
and commercial expertise to invest in and grow its pharmaceutical
products across a range of therapeutic areas, including women’s
health. For additional company information, please visit
www.amagpharma.com.
APPROVED PRODUCTSAbout Feraheme®
(ferumoxytol injection)Feraheme received marketing
approval from the U.S. Food and Drug Administration (FDA) in June
2009 for the treatment of iron deficiency anemia (IDA) in adult
patients with chronic kidney disease (CKD). In February 2018, the
FDA approved the supplemental New Drug Application (NDA) to expand
the label beyond the CKD indication to include all eligible adult
IDA patients who have intolerance to oral iron or have had
unsatisfactory response to oral iron in addition to patients who
have CKD.
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.
Feraheme is protected in the U.S. by seven issued patents
covering the composition and dosage form of the product, the last
of which expires in June 2023. Certain of these patents are the
subject of a settlement agreement with Sandoz Inc.
For additional product information, including full prescribing
information and the Boxed Warning, please visit
www.feraheme.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. Makena was
approved by the FDA in February 2011 and was
granted orphan drug exclusivity through February 3, 2018. In
February of 2018, AMAG introduced the prefilled Makena
auto-injector containing a short, thin, non-visible needle for
subcutaneous use, offering patients and providers a new
administration option.
Makena has certain limitations 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.
A multicenter, randomized, double-blind, vehicle
(placebo)-controlled clinical trial (the Meis trial), which served
as the basis for the FDA’s approval of Makena, demonstrated a
statistically significant and clinically relevant reduction in the
rate of preterm birth at 37 weeks in the Makena arm (36.3%)
compared to the placebo arm (54.9 %). There are no controlled
trials demonstrating a direct clinical benefit, such as improvement
in neonatal mortality and morbidity.
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 effect
reported with the Makena auto-injector use (and higher than with
the Makena intramuscular injection) was injection site pain.
AMAG developed the Makena auto-injector with its device
partner Antares Pharma, Inc., which holds issued patents
on the auto-injector device and drug-device combination, the last
of which expires in 2034. AMAG also holds a U.S.
patent directed to subcutaneous administration and dosing of
the Makena auto-injector product, which expires in 2036.
For additional product information, including full prescribing
information, please visit www.makena.com.
About Intrarosa® (prasterone) vaginal
insertsIntrarosa is the only vaginal non-estrogen
treatment 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 sex
steroid. Prasterone is converted by enzymes in the body into
androgens and estrogens. Intrarosa’s mechanism of action is not
fully established.
In clinical studies, Intrarosa demonstrated efficacy by reducing
pain during intercourse (dyspareunia), as well as improvement in
the percentage of superficial cells and parabasal cells, and
vaginal pH. 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 clinical studies, vaginal discharge and abnormal Pap smears
were the most common adverse reactions (≥ 2%). Intrarosa is
contraindicated in women with undiagnosed abnormal genital
bleeding.
Intrarosa is protected by a number of U.S. patents and
applications that are owned by Endoceutics, Inc. One issued patent
includes drug product claims with a term that expires in 2031. Two
additional issued patents include method of use claims and
pharmaceutical dosage form claims with terms that expire in
2028.
For additional product information, including full prescribing
information, please visit www.intrarosa.com.
PRODUCTS IN DEVELOPMENTAbout VyleesiTM
(bremelanotide)Vyleesi, an investigational product
candidate, is being developed for the treatment of hypoactive
sexual desire disorder (HSDD) in pre-menopausal women.
Vyleesi is designed to be used in anticipation of a sexual
encounter, and is thought to possess a novel mechanism of action
that impacts the excitatory neural pathways in the brain to restore
sexual desire.
Vyleesi has been studied in more than 30 clinical trials with
over 2,500 women. AMAG’s NDA to the FDA was supported by
clinical data from two large double-blind placebo-controlled Phase
3 studies in which Vyleesi met the pre-specified co-primary
efficacy endpoints of improvement in desire and decrease in
distress associated with low sexual desire as measured by validated
patient-reported outcomes. Women in the trials had the option,
after completion of the trial, to continue in an 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 received Vyleesi.
The most common adverse events were nausea, flushing, injection
site reactions and headache. The majority of events were reported
to be transient and mild-to-moderate in intensity. Vyleesi has no
known alcohol interactions.
Vyleesi is protected by a number of U.S. and foreign patents and
applications that are owned by Palatin Technologies, Inc. Certain
of the patents include claims directed to the Vyleesi drug
composition and methods of use thereof with terms expiring in 2020,
and other patents include claims directed to methods of treating
female sexual dysfunction by subcutaneous administration of
compositions that include Vyleesi with terms expiring in 2033.
About AMAG-423 (Digoxin Immune Fab
(ovine))AMAG-423 is a polyclonal antibody in development
for the treatment of severe preeclampsia in pregnant women and has
been granted both orphan drug and fast-track review designations by
the FDA. There are currently no FDA-approved treatment options for
severe preeclampsia, a leading cause of maternal and neonatal
mortality.
Elevated levels of endogenous digitalis-like factors (EDLFs)
have been found in the placental and maternal circulation of the
majority of patients with preeclampsia, and the degree of elevation
has been correlated with severity of changes in creatinine
clearance (a measure of kidney function). AMAG-423 is thought
to bind to EDLFs, causing a decrease in EDLF activity and thereby
increasing their elimination.
The Digibind Efficacy Evaluation in Preeclampsia (DEEP) trial, a
placebo-controlled Phase 2 proof-of-concept study in 51 pregnant
women with severe preeclampsia, was suggestive of clinical benefit
in both mothers and their babies. In the DEEP Trial, the most
frequent adverse events were nausea, vomiting, gastroenteritis and
hypotension.
AMAG is currently conducting a Phase 2b/3a clinical study, which
is expected to enroll approximately 200 antepartum women with
severe preeclampsia between 23 and 32 weeks gestation in a
multi-center, randomized, double-blind, placebo-controlled,
parallel-group study.
AMAG-423 is protected in the U.S. by four patents covering
methods of using AMAG-423 to treat women exhibiting symptoms of
preeclampsia or eclampsia, each of which expires in November 2022.
AMAG-423 has been granted orphan drug designation by the FDA and,
if approved, would expect to receive seven years of marketing
exclusivity.
Another company is currently marketing Digoxin Immune Fab
(ovine), an FDA-approved treatment for patients with
life-threatening or potentially life-threatening digoxin toxicity
or overdose, which is being sold in a different dosage than our
currently expected dosage of AMAG-423.
About CiraparantagCiraparantag is
being investigated for patients treated with novel oral
anticoagulants (NOACs) or low molecular weight heparin (LMWH) when
reversal of the anticoagulant effect of these products is needed
for emergency surgery, urgent procedures or due to life-threatening
or uncontrolled bleeding. It is believed that ciraparantag
exerts its effects by binding to and blocking the effects
of NOACs such as Xarelto® (rivaroxaban), Eliquis® (apixaban)
and Savaysa® (edoxaban), as well as to the LMWH Lovenox®
(enoxaparin sodium injection), which in turn reestablishes
normal clot formation.
AMAG plans to work with the FDA to confirm the design of
the Phase 3 program, which is expected to include Phase 3 trials in
healthy volunteers followed by a Phase 3b/4 trial in patients.
Ciraparantag has been well tolerated in clinical trials. To
date, the most common adverse events related
to ciraparantag have been mild transient sensations of
coolness, warmth or tingling, skin flushing, and alterations in
taste.
Ciraparantag has been granted Fast Track review designation
by the FDA and has patent protection through 2034.
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, beliefs about the underlying demand for the
subcutaneous auto-injector, the status of the Makena IM supply
outage, the Company’s progress to replace its previous primary
Makena IM supplier and expectations that the Makena supply outage
will be remediated in the second quarter; beliefs about novel
pipeline assets being the future value drivers of the company;
expectations as to the timing of FDA approval for Vyleesi;
expectations as to the timing of the Phase 3a clinical studies for
ciraparantag; AMAG’s accomplishments and first quarter financial
results, including the market share captured by AMAG’s products and
such products’ performance; beliefs about physician support of the
SC auto-injector and sustainability of the Makena franchise;
expectations regarding Feraheme’s future performance; beliefs about
the Intrarosa direct-to-consumer campaign; plans to continue to
invest in AMAG’s products and product candidates; and expectations
regarding AMAG's financial guidance, including revenues, operating
loss, and non-GAAP adjusted EBITDA are based on management’s
current expectations and beliefs and 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 risk
that sales of branded and generic formulations of Makena will
continue to be negatively impacted by the supply disruption and
recent and future generic entries in the market, including if the
supply disruption is not remediated on the expected timeline, or at
all; the risk that the FDA will not approve new suppliers for the
Makena IM product in a timely manner, or at all, and, even if
approved, the risk that any such newly approved supplier will
encounter similar supply disruptions or that AMAG will otherwise be
unable to meet demand for its products; the risk that the Makena
brand will incur reputational harm as result of the supply outage
or recently disclosed study results, which could harm AMAG’s
ability to retain or regain market share and could further
negatively impact sales; as well as 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, 2018 and subsequent filings with the SEC, which
are available at the SEC’s website at www.sec.gov. 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®, the "A" logo, and "Feraheme® are
registered trademarks of AMAG Pharmaceuticals, Inc. VyleesiTM is a
trademark of AMAG Pharmaceuticals, Inc. Makena® is a registered
trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered
trademark of Endoceutics, Inc. Other trademarks referenced in this
report are the property of their respective owners
– Tables Follow –
AMAG Pharmaceuticals,
Inc.Condensed Consolidated Statements of
Operations(Unaudited, amounts in thousands, except
for per share data)
|
Three Months Ended March 31, |
|
2019 |
|
2018 |
Revenues: |
|
|
|
Makena |
$ |
31,257 |
|
|
$ |
89,983 |
|
Feraheme/MuGard |
40,058 |
|
|
25,200 |
|
Intrarosa |
4,414 |
|
|
2,165 |
|
Other
revenues |
75 |
|
|
39 |
|
Total
revenues |
75,804 |
|
|
117,387 |
|
Operating costs and
expenses: |
|
|
|
Cost of
product sales |
18,477 |
|
|
63,912 |
|
Research
and development expenses |
18,066 |
|
|
10,809 |
|
Acquired
in-process research and development |
74,856 |
|
|
20,000 |
|
Selling,
general and administrative expenses |
74,682 |
|
|
73,431 |
|
Restructuring expenses |
7,420 |
|
|
— |
|
Total
costs and expenses |
193,501 |
|
|
168,152 |
|
Operating loss |
(117,697 |
) |
|
(50,765 |
) |
|
|
|
|
Other income
(expense): |
|
|
|
Interest
expense |
(6,450 |
) |
|
(15,977 |
) |
Interest
and dividend income |
1,586 |
|
|
643 |
|
Other
income |
340 |
|
|
— |
|
Total
other expense, net |
(4,524 |
) |
|
(15,334 |
) |
Loss from continuing
operations before income taxes |
(122,221 |
) |
|
(66,099 |
) |
Income tax benefit |
(137 |
) |
|
(8,000 |
) |
Net loss from
continuing operations |
$ |
(122,084 |
) |
|
$ |
(58,099 |
) |
|
|
|
|
Discontinued
Operations: |
|
|
|
Income
from discontinued operations |
$ |
— |
|
|
$ |
5,878 |
|
|
|
|
|
|
|
Income
tax expense |
— |
|
|
2,021 |
|
|
|
|
|
|
|
Net income from
discontinued operations |
$ |
— |
|
|
$ |
3,857 |
|
|
|
|
|
Net loss |
$ |
(122,084 |
) |
|
$ |
(54,242 |
) |
|
|
|
|
Basic and diluted net
income (loss) per share: |
|
|
|
Loss from
continuing operations |
$ |
(3.54 |
) |
|
$ |
(1.70 |
) |
Income
from discontinued operations |
— |
|
|
0.11 |
|
Basic and diluted net
loss per share |
$ |
(3.54 |
) |
|
$ |
(1.59 |
) |
|
|
|
|
Weighted average shares
outstanding used to compute net income (loss) per share (basic and
diluted) |
34,469 |
|
|
34,162 |
|
AMAG
Pharmaceuticals, Inc.Condensed Consolidated
Balance Sheets(Unaudited, amounts in
thousands)
|
March 31, 2019 |
|
December 31, 2018 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
137,917 |
|
|
$ |
253,256 |
|
Marketable securities |
128,593 |
|
|
140,915 |
|
Accounts
receivable, net |
83,334 |
|
|
75,347 |
|
Inventories |
29,664 |
|
|
26,691 |
|
Prepaid
and other current assets |
40,567 |
|
|
18,961 |
|
Note
receivable |
— |
|
|
10,000 |
|
Total
current assets |
420,075 |
|
|
525,170 |
|
Property and equipment,
net |
8,995 |
|
|
7,521 |
|
Goodwill |
422,513 |
|
|
422,513 |
|
Intangible assets,
net |
213,090 |
|
|
217,033 |
|
Operating lease
right-of-use asset |
7,024 |
|
|
— |
|
Deferred tax
assets |
630 |
|
|
1,260 |
|
Restricted cash |
495 |
|
|
495 |
|
Other long-term
assets |
29 |
|
|
1,467 |
|
Total
assets |
$ |
1,072,851 |
|
|
$ |
1,175,459 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
21,535 |
|
|
$ |
14,487 |
|
Accrued
expenses |
155,687 |
|
|
129,537 |
|
Current
portion of convertible notes, net |
— |
|
|
21,276 |
|
Current
portion of operating lease liability |
3,529 |
|
|
— |
|
Current
portion of deferred revenue |
2,112 |
|
|
— |
|
Current
portion of acquisition-related contingent consideration |
118 |
|
|
144 |
|
Total
current liabilities |
182,981 |
|
|
165,444 |
|
Long-term
liabilities: |
|
|
|
Convertible notes, net |
265,576 |
|
|
261,933 |
|
Long-term
operating lease liability |
4,328 |
|
|
— |
|
Long-term
deferred revenue |
4,288 |
|
|
— |
|
Long-term
acquisition-related contingent consideration |
218 |
|
|
215 |
|
Other
long-term liabilities |
741 |
|
|
1,212 |
|
Total
liabilities |
458,132 |
|
|
428,804 |
|
Commitments and
contingencies |
|
|
|
Stockholders’
equity: |
|
|
|
Preferred
stock, par value $0.01 per share, 2,000,000 shares authorized; none
issued |
— |
|
|
— |
|
Common
stock, par value $0.01 per share, 117,500,000 shares authorized;
33,746,828 and 34,606,760 shares issued and outstanding at
March 31, 2019 and December 31, 2018, respectively |
337 |
|
|
346 |
|
Additional paid-in capital |
1,282,284 |
|
|
1,292,736 |
|
Accumulated other comprehensive loss |
(3,376 |
) |
|
(3,985 |
) |
Accumulated deficit |
(664,526 |
) |
|
(542,442 |
) |
Total
stockholders’ equity |
614,719 |
|
|
746,655 |
|
Total
liabilities and stockholders’ equity |
$ |
1,072,851 |
|
|
$ |
1,175,459 |
|
AMAG
Pharmaceuticals, Inc.Condensed Consolidated
Statements of Cash Flows(Unaudited, amounts in
thousands)
|
Three Months Ended March 31, |
|
2019 |
|
2018 |
Cash flows from
operating activities: |
|
|
|
Net loss |
$ |
(122,084 |
) |
|
$ |
(54,242 |
) |
Adjustments to
reconcile net loss to net cash provided by operating
activities: |
|
|
|
Depreciation and amortization |
4,375 |
|
|
59,485 |
|
Provision
for bad debt expense |
(16 |
) |
|
463 |
|
Amortization of premium/discount on purchased securities |
(27 |
) |
|
67 |
|
Non-cash
equity-based compensation expense |
4,873 |
|
|
5,533 |
|
Amortization of debt discount and debt issuance costs |
3,783 |
|
|
3,880 |
|
Change in
fair value of contingent consideration |
(6 |
) |
|
626 |
|
Deferred
income taxes |
458 |
|
|
(6,643 |
) |
Changes in operating
assets and liabilities: |
|
|
|
Accounts
receivable, net |
(7,971 |
) |
|
3,093 |
|
Inventories |
(2,973 |
) |
|
3,534 |
|
Prepaid
and other current assets |
(21,606 |
) |
|
(3,720 |
) |
Accounts
payable and accrued expenses |
33,087 |
|
|
30,374 |
|
Deferred
revenues |
6,400 |
|
|
3,027 |
|
Other
assets and liabilities |
1,799 |
|
|
215 |
|
Net cash
(used in) provided by operating activities |
(99,908 |
) |
|
45,692 |
|
Cash flows from
investing activities: |
|
|
|
Proceeds
from sales or maturities of marketable securities |
27,945 |
|
|
18,225 |
|
Purchase
of marketable securities |
(14,815 |
) |
|
(21,102 |
) |
Settlement of note receivable |
10,000 |
|
|
— |
|
Capital
expenditures |
(1,794 |
) |
|
(923 |
) |
Net cash
provided by (used in) investing activities |
21,336 |
|
|
(3,800 |
) |
Cash flows from
financing activities: |
|
|
|
Payments
to settle convertible notes |
(21,417 |
) |
|
— |
|
Payments
of contingent consideration |
(17 |
) |
|
(44 |
) |
Payments
for repurchases of common stock |
(13,730 |
) |
|
— |
|
Proceeds
from the exercise of common stock options |
33 |
|
|
123 |
|
Payments
of employee tax withholding related to equity-based
compensation |
(1,636 |
) |
|
(2,348 |
) |
Net cash
used in financing activities |
(36,767 |
) |
|
(2,269 |
) |
Net (decrease) increase
in cash, cash equivalents, and restricted cash |
(115,339 |
) |
|
39,623 |
|
Cash, cash equivalents,
and restricted cash at beginning of the period |
253,751 |
|
|
192,770 |
|
Cash, cash equivalents,
and restricted cash at end of the period |
$ |
138,412 |
|
|
$ |
232,393 |
|
Supplemental data for
cash flow information: |
|
|
|
Cash paid
for taxes |
$ |
78 |
|
|
$ |
136 |
|
Cash paid
for interest |
$ |
267 |
|
|
$ |
18,971 |
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended March
31, 2019(Unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Research & development |
|
Selling, general &
administrative |
|
Acquired IPR&D |
|
Restructuring |
|
Operating Income / Adjusted
EBITDA |
GAAP |
$ |
75,804 |
|
|
$ |
18,477 |
|
|
$ |
18,066 |
|
|
$ |
74,682 |
|
|
$ |
74,856 |
|
|
$ |
7,420 |
|
|
$ |
(117,697 |
) |
Depreciation and
intangible asset amortization |
— |
|
|
(3,943 |
) |
|
(8 |
) |
|
(424 |
) |
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(202 |
) |
|
(680 |
) |
|
(3,325 |
) |
|
— |
|
|
— |
|
|
|
Acquisition-related
costs |
— |
|
|
— |
|
|
— |
|
|
(270 |
) |
|
— |
|
|
— |
|
|
|
Restructuring |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(7,420 |
) |
|
|
Acquired IPR&D |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(74,856 |
) |
|
|
|
|
Non-GAAP
Adjusted |
$ |
75,804 |
|
|
$ |
14,332 |
|
|
$ |
17,378 |
|
|
$ |
70,663 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(26,569 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended March
31, 2018(Unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Research & development |
|
Selling, general &
administrative |
|
Acquired IPR&D |
|
Operating Income / Adjusted
EBITDA |
GAAP |
$ |
117,387 |
|
|
$ |
63,912 |
|
|
$ |
10,809 |
|
|
$ |
73,431 |
|
|
$ |
20,000 |
|
|
$ |
(50,765 |
) |
Depreciation and
intangible asset amortization |
— |
|
|
(52,364 |
) |
|
— |
|
|
(759 |
) |
|
— |
|
|
|
Non-cash inventory
step-up adjustments |
— |
|
|
(2,223 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based
compensation |
— |
|
|
(200 |
) |
|
(720 |
) |
|
(3,870 |
) |
|
— |
|
|
|
Adjustments to
contingent consideration |
— |
|
|
— |
|
|
— |
|
|
(626 |
) |
|
— |
|
|
|
Acquired IPR&D |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(20,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjusted |
$ |
117,387 |
|
|
$ |
9,125 |
|
|
$ |
10,089 |
|
|
$ |
68,176 |
|
|
$ |
— |
|
|
$ |
29,997 |
|
AMAG
Pharmaceuticals, Inc.Reconciliation of GAAP
to Non-GAAP 2019 Financial Guidance(Unaudited,
amounts in millions)
|
2019 Financial Guidance |
Operating
loss3 |
($206) - ($176) |
Depreciation &
intangible asset amortization |
36 |
Stock-based
compensation |
22 |
Non-cash inventory step up
and adjustments to contingent consideration |
1 |
Acquired IPR&D |
75 |
Restructuring |
7 |
|
|
|
|
Non-GAAP adjusted EBITDA |
($65) - ($35) |
AMAG
Pharmaceuticals, Inc.Share Count
Reconciliation(Unaudited, amounts in
millions)
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
2018 |
|
Weighted
average basic shares outstanding |
|
34.5 |
|
|
34.2 |
|
|
Employee
equity incentive awards |
|
— |
|
4 |
— |
|
4 |
GAAP diluted
shares outstanding |
|
34.5 |
|
|
34.2 |
|
|
Employee
equity incentive awards |
|
0.2 |
|
5 |
0.2 |
|
5 |
Non-GAAP
diluted shares outstanding |
|
34.7 |
|
|
34.4 |
|
|
CONTACT:AMAG Pharmaceuticals, Inc.Linda
LennoxVice President, Investor RelationsO: 617-498-2846M:
908-627-3424
1 See summaries of GAAP to non-GAAP adjustments at the
conclusion of this press release.
2 See reconciliations of 2019 GAAP to non-GAAP financial
guidance at conclusion of this press release.
3 As previously reported, the 2019 operating loss guidance range
issued in January 2019 excluded the potential accounting impact for
the acquisition of Perosphere, which had not closed at that time.
The operating loss guidance range has now been adjusted to
incorporate the $74.9 million accounting impact of the Perosphere
acquisition, which was recorded in the first quarter of 2019.
4 Employee equity incentive awards would be anti-dilutive in
this period.5 Reflects the non-GAAP dilutive impact of employee
equity incentive awards.
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