AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited
consolidated financial results for the third quarter ended
September 30, 2019 and provided a business update.
“We’re pleased with the strong performance of Feraheme which
posted a record quarter of more than $44 million in revenue, and
the Makena subcutaneous auto-injector which held market share and
generated revenue of more than $41 million despite continued
generic competition. As we look toward the remainder of 2019 and
beyond, AMAG continues to focus on strong commercial execution and
progressing our new drug candidates through clinical development,
and we remain on track for adjusted EBITDA neutrality in 2020,”
said William Heiden, AMAG president and chief executive officer.
“While we are disappointed with the mixed vote of the U.S. Food and
Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs
Advisory Committee (BRUDAC), we are committed to working with the
FDA on a path forward that could allow at-risk pregnant women to
continue to have access to Makena."
KEY UPDATES
- Vyleesi launched nationally in
September○ Through four weeks post launch, more than
3,000 Vyleesi prescriptions have been written across more than
1,300 prescribing healthcare providers.
- Continued strong revenue and market share performance
across promoted products○ Makena®
(hydroxyprogesterone caproate injection) subcutaneous (SC)
auto-injector maintained 63% market share of all FDA-approved
hydroxyprogesterone caproate prescription volume in the quarter.○
Feraheme® (ferumoxytol injection) grew market share to 17.5% in the
third quarter.○ Intrarosa® (prasterone) average market share of
total prescriptions grew to 4.8%.
($M) |
Three Months Ended September 30, |
|
|
2019 |
|
|
|
2018 |
|
|
% Change |
Total product revenues, net |
$ |
84.1 |
|
|
$ |
122.2 |
|
|
(31 |
)% |
Feraheme |
|
44.2 |
|
|
|
37.0 |
|
|
20 |
% |
Makena subcutaneous auto-injector |
|
41.3 |
|
|
|
39.2 |
|
|
5 |
% |
Makena intramuscular - branded and generic |
|
(7.0 |
) |
|
|
41.0 |
|
|
N/A |
|
Intrarosa |
|
5.6 |
|
|
|
4.9 |
|
|
14 |
% |
Other |
|
— |
|
|
|
0.1 |
|
|
— |
|
Operating
loss |
$ |
(18.0 |
) |
|
$ |
(19.3 |
) |
|
N/A |
|
Non-GAAP adjusted EBITDA1 |
$ |
(8.2 |
) |
|
$ |
30.0 |
|
|
N/A |
|
1 See reconciliations of GAAP to non-GAAP adjustments at the
conclusion of this press release.
MAKENA FDA ADVISORY COMMITTEE UPDATEOn October
29, 2019, the FDA held an advisory committee meeting to better
understand and interpret the PROLONG (Progestin's Role in
Optimizing Neonatal Gestation) confirmatory trial for Makena. While
the committee discussed multiple questions, on the key
question, seven committee members voted to leave the product
on the market under accelerated approval and require a new
confirmatory trial and nine advisory committee members voted to
recommend that the FDA pursue withdrawal of approval for Makena.
The approval of Makena was based on the Meis trial, conducted by
the National Institute of Child Health and Human Development and
the Maternal-Fetal Medicine Units Network and published in the New
England Journal of Medicine in 2003. The PROLONG trial was
conducted post approval under the FDA's Subpart H accelerated
approval process.
Makena’s active ingredient, 17α hydroxyprogesterone caproate
(often referred to as 17P), is the only FDA-approved treatment for
pregnant women who have had a prior spontaneous preterm birth
(which is a substantial risk factor for recurrent preterm birth).
17P has been recognized as the standard of care and used for more
than a decade by healthcare providers to treat patients with a
history of spontaneous preterm birth, which represents
approximately 130,000 births a year in the U.S. The American
College of Obstetricians and Gynecologists (ACOG) and Society for
Maternal-Fetal Medicine (SMFM) recently (October 25, 2019)
reiterated their continued support of the use of Makena for at-risk
pregnant women.
The withdrawal of all FDA-approved formulations of
hydroxyprogesterone caproate would take away an important, and
safe, treatment option for high-risk pregnant women. AMAG firmly
believes in the safety and efficacy of Makena and remains committed
to working collaboratively with the FDA on a path forward to ensure
eligible pregnant women continue to have access to 17P, the only
FDA-approved therapy for this orphan condition.
VYLEESI LAUNCH UPDATEAMAG launched Vyleesi
nationally in September with its established women’s health sales
force of approximately 125 sales representatives who also support
Makena and Intrarosa. In the four weeks since the national launch,
more than 1,300 healthcare providers have prescribed Vyleesi, which
has resulted in more than 3,000 prescriptions received by our
specialty pharmacy partners to date.
The company is working with payers and healthcare professionals
to help ensure that women with hypoactive sexual desire disorder
(HSDD) have access to Vyleesi. To help women access
treatment, AMAG offers a copay assistance program so that
eligible patients can obtain their first four-pack of Vyleesi
auto-injectors at no cost. Under the current copay program, women
who choose to refill their prescriptions can receive a four-pack
of Vyleesi for no more than $99.
CIRAPARANTAG UPDATEThe company is planning to
conduct a clinical study in healthy volunteers to confirm the
lowest effective dose of ciraparantag after reaching peak steady
state blood concentrations of certain novel oral anticoagulant
(NOAC) drugs. This proposed study will utilize an automated
coagulometer developed by Perosphere Technologies, an independent
company, to measure whole blood clotting time. The
coagulometer requires FDA clearance for use in clinical studies
through an investigational device exemption (IDE), which Perosphere
Technologies will submit once the healthy subject study design is
finalized. Over the past several months, Perosphere Technologies
has completed additional analytic studies and AMAG continues to
work with the FDA on the design of the next clinical study.
Following the completion of this study (estimated second half
2020), the company plans to schedule an End of Phase 2
meeting with the FDA to discuss the design of the Phase 3
program evaluating the safety and efficacy of ciraparantag in the
target patient population.
2019 FINANCIAL GUIDANCE UPDATE“We’re tightening
our guidance range for the full year of 2019. On a revenue basis,
we are lowering the mid-point from $340 million to $325 million;
however, we are lowering our expected adjusted EBITDA loss from a
mid-point of $80 million to $70 million by continuing to carefully
manage expenses and aggressively reprioritizing our spend to
optimize the value in our portfolio," said Ted Myles, AMAG’s chief
financial officer. "This is evident in our adjusted
EBITDA loss trend, which was approximately $50 million in the first
half of 2019 and we expect to be less than $20 million in
the second half of 2019.”
Mr. Myles continued, “We firmly believe in Makena and are
committed to working with the FDA. While these conversations
continue, we recognize that the advisory committee vote heightens
uncertainty around the durability of Makena revenue. We are
prepared for a variety of potential scenarios and continue to look
for ways to optimize the value of our portfolio to maximize
shareholder value. As we gain more clarity on the path forward with
the FDA regarding Makena, we’ll be in a better position to provide
formal revenue and earnings guidance for 2020.”
2019 Financial Guidance |
|
|
|
|
($M) |
|
Updated |
|
Previous |
Total revenue |
|
$320 - $330 |
|
$325 - $355 |
Operating loss |
|
($278) - ($268) |
|
($286) - ($276) |
Adjusted EBITDA2 |
|
($75) - ($65) |
|
($85) - ($75) |
2 See reconciliations of 2019 GAAP to non-GAAP financial
guidance at conclusion of this press release.
THIRD QUARTER ENDED SEPTEMBER
30RevenueThe company’s commercial
organization drove strong market share and revenue performance
across all key marketed products.
- Makena SC auto-injector revenue totaled $41.3 million, compared
with $39.2 million in the same period last year, which is in-line
with the company's quarterly expectation for this product.
- The company did not ship any Makena IM product during the third
quarter of 2019, therefore the full impact of the change in
estimated commercial rebate liabilities from prior period sales
appears as negative revenue during the quarter.
- Feraheme achieved record quarterly revenue of $44.2 million, an
increase of 20% over the same period last year. Feraheme’s average
quarterly market share increased to 17.5%, compared with 15.7% in
the third quarter last year, and 17.2% in the second quarter of
2019.
- Intrarosa revenue in the third quarter of 2019 totaled $5.6
million, compared with $4.9 million in the same period last year.
The average quarterly share of total prescriptions grew to 4.8%,
compared with 3.8% in the third quarter last year, and 4.3% in the
second quarter of 2019.
($M) |
Three Months Ended September 30, |
|
|
2019 |
|
|
2018 |
|
Total product
revenues, net |
$ |
84.1 |
|
$ |
122.2 |
|
Feraheme |
|
44.2 |
|
|
37.0 |
|
Makena subcutaneous auto-injector |
|
41.3 |
|
|
39.2 |
|
Makena intramuscular - branded and generic |
|
(7.0 |
) |
|
41.0 |
|
Intrarosa |
|
5.6 |
|
|
4.9 |
|
Other |
|
— |
|
|
0.1 |
|
Operating Expenses
- Cost of products sales (CoPS) in the third quarter of 2019
decreased by $25.4 million, driven by a $26.7 million decrease in
amortization expense associated with the Makena IM intangible
asset. Non-amortization CoPS as a percent of net revenue increased
due to a lower net price for Makena and a shift to products with
higher CoPS and royalty burdens.
- Research and development (R&D) expenses totaled $15.3
million, compared with $10.1 million in the third quarter of last
year. This increase included additional clinical site initiations
in Europe for the AMAG-423 development program.
- In the third quarter of 2018, the company recorded $12.5
million of acquired in-process R&D (IPR&D) expense in
connection with the acquisition of AMAG-423, with no comparable
expense in the third quarter of 2019.
- Selling, general and administrative (SG&A) expenses totaled
$65.7 million in the third quarter of 2019, compared with $72.5
million in the third quarter of 2018. This decrease was primarily
related to combining the company's maternal health and women's
health sales forces in February 2019, partially offset by increased
investment in the launch of Vyleesi.
($M) |
Three Months Ended September 30, |
|
|
2019 |
|
|
2018 |
|
Amortization of intangible assets |
$ |
4.2 |
|
$ |
30.9 |
|
Direct cost of product sales |
|
16.9 |
|
|
15.6 |
|
Total cost of product
sales |
|
21.1 |
|
|
46.5 |
|
Research and
development expenses |
|
15.3 |
|
|
10.1 |
|
Acquired in-process
research and development |
|
— |
|
|
12.5 |
|
Selling, general and
administrative expenses |
|
65.7 |
|
|
72.5 |
|
Total costs and expenses |
$ |
102.1 |
|
$ |
141.6 |
|
Balance Sheet
- As of September 30, 2019, the company’s cash and
investments totaled $191.5 million.
- Long-term debt totaled $320.0 million (representing the
principal amounts outstanding of the 2022 convertible notes).
Operating Loss and Adjusted EBITDA
- The company reported an operating loss of $18.0 million in the
third quarter of 2019, compared with an operating loss of $19.3
million in the same period last year.
- The company reported an adjusted EBITDA loss of $8.2 million in
the third quarter of 2019, compared with adjusted EBITDA of $30.0
million in the third quarter of last year.
- On a sequential basis, the adjusted EBITDA loss improved from
$24.4 million in the second quarter of 2019 to $8.2 million, due to
revenue growth across the commercial portfolio and lower SG&A
expenses in the third quarter.
($M) |
Three Months Ended September 30, |
|
|
2019 |
|
|
2018 |
|
Operating
loss |
$ |
(18.0 |
) |
$ |
(19.3 |
) |
Non-GAAP adjusted EBITDA1 |
$ |
(8.2 |
) |
$ |
30.0 |
|
3 See reconciliations of GAAP to non-GAAP adjustments at the
conclusion of this press release.
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 third 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:
6261528
Replay Dial-in Number: (855) 859-2056Replay International
Dial-in Number: (404) 537-3406Conference ID: 6261528
A telephone replay will be available from approximately 11:00
a.m. ET on November 1, 2019 through midnight on November 8,
2019.
The webcast with slides will be accessible through the Investors
section of the company’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, non-GAAP adjusted EBITDA (earnings before
income taxes, depreciation and amortization) and non-GAAP diluted
shares outstanding. 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 its 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.
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 performance of AMAG’s commercially
available products; expectations regarding the effect of
realignment of AMAG’s marketing spend in women’s health;
expectations for ciraparantag and AMAG-423 studies, including
development timelines; plans to work collaboratively with the FDA
and expectations that there may be a path forward to ensure
eligible patients continue to have access to 17P; plans to ensure
that women with HSDD have access to Vyleesi, including at a
reasonable cost; updated 2019 guidance, including expectations as
to adjusted EBITDA loss for 2019; expectations that AMAG remains on
track for adjusted EBITDA neutrality in 2020; and beliefs regarding
AMAG's ability to optimize the value of its portfolio to maximize
shareholder value 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 the FDA will withdraw approval of Makena in line with the
recommendation of BRUDAC that approval of 17P be withdrawn; the
risk that the FDA could take other adverse action related to Makena
given the findings and recommendation of BRUDAC; the risk that AMAG
may not be able to generate additional efficacy data that will be
satisfactory to the FDA (if the FDA permits AMAG to submit
additional data to support or as a condition to the continued
commercialization of Makena); the risk that healthcare providers
may be reluctant to continue to prescribe the Makena auto-injector
or the FDA may require that the Makena label include information on
the PROLONG study, restrictions to the current indication or the
insertion of new warnings or precautions, 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, its Quarterly Report on Form
10-Q for the quarters ended March 31, 2019 and June 30, 2019, and
subsequent filings with the SEC (including its upcoming Quarterly
Report on Form 10-Q for the quarter ended September 30, 2019),
which are available at the SEC’s website at www.sec.gov.
Further, investors are encouraged to read those risks identified on
slide 3 of AMAG’s presentation attached as Exhibit 99.2 to AMAG’s
Current Report on Form 8-K furnished with the SEC on or about the
date hereof for risks attendant to AMAG’s long-term outlook,
including that it will be adjusted EBITDA neutral in 2020, which
assumes that AMAG will be able to continue to commercialize Makena
and that approval of the product will not be withdrawn by the FDA,
which withdrawal was recommended by BRUDAC at their advisory
committee meeting held on October 29, 2019. 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.
- Tables Follow -
AMAG Pharmaceuticals,
Inc.Condensed Consolidated Statements of
Operations(Unaudited, amounts in thousands, except
for per share data)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenues: |
|
|
|
|
|
|
|
Feraheme |
$ |
44,205 |
|
|
$ |
36,963 |
|
|
$ |
126,294 |
|
|
$ |
99,796 |
|
Makena |
34,272 |
|
|
80,221 |
|
|
96,464 |
|
|
275,377 |
|
Intrarosa |
5,607 |
|
|
4,925 |
|
|
14,898 |
|
|
10,331 |
|
Other product sales |
23 |
|
|
129 |
|
|
156 |
|
|
302 |
|
Other revenues |
24 |
|
|
— |
|
|
231 |
|
|
75 |
|
Total revenues |
84,131 |
|
|
122,238 |
|
|
238,043 |
|
|
385,881 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of product sales |
21,105 |
|
|
46,489 |
|
|
63,871 |
|
|
187,176 |
|
Research and development expenses |
15,330 |
|
|
10,133 |
|
|
48,377 |
|
|
32,635 |
|
Acquired in-process research and development |
— |
|
|
12,500 |
|
|
74,856 |
|
|
32,500 |
|
Selling, general and administrative expenses |
65,720 |
|
|
72,451 |
|
|
217,727 |
|
|
161,780 |
|
Impairment of intangible assets |
— |
|
|
— |
|
|
77,358 |
|
|
— |
|
Restructuring expenses |
— |
|
|
— |
|
|
7,420 |
|
|
— |
|
Total costs and expenses |
102,155 |
|
|
141,573 |
|
|
489,609 |
|
|
414,091 |
|
Operating loss |
(18,024 |
) |
|
(19,335 |
) |
|
(251,566 |
) |
|
(28,210 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest expense |
(6,419 |
) |
|
(13,366 |
) |
|
(19,199 |
) |
|
(45,400 |
) |
Loss on debt extinguishment |
— |
|
|
(35,922 |
) |
|
— |
|
|
(35,922 |
) |
Interest and dividend income |
840 |
|
|
1,612 |
|
|
3,650 |
|
|
3,207 |
|
Gains on marketable securities, net |
263 |
|
|
— |
|
|
263 |
|
|
— |
|
Other income |
(45 |
) |
|
(19 |
) |
|
298 |
|
|
(63 |
) |
Total other expense, net |
(5,361 |
) |
|
(47,695 |
) |
|
(14,988 |
) |
|
(78,178 |
) |
Loss from continuing
operations before income taxes |
(23,385 |
) |
|
(67,030 |
) |
|
(266,554 |
) |
|
(106,388 |
) |
Income tax expense
(benefit) |
232 |
|
|
(2,352 |
) |
|
(26 |
) |
|
42,204 |
|
Net loss from continuing
operations |
$ |
(23,617 |
) |
|
$ |
(64,678 |
) |
|
$ |
(266,528 |
) |
|
$ |
(148,592 |
) |
|
|
|
|
|
|
|
|
Discontinued Operations: |
|
|
|
|
|
|
|
Income from discontinued operations |
$ |
— |
|
|
$ |
5,838 |
|
|
$ |
— |
|
|
$ |
18,873 |
|
Gain on sale of CBR business |
— |
|
|
89,581 |
|
|
— |
|
|
89,581 |
|
Income tax (benefit) expense |
— |
|
|
(98 |
) |
|
— |
|
|
3,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income from discontinued
operations |
$ |
— |
|
|
$ |
95,517 |
|
|
$ |
— |
|
|
$ |
105,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
$ |
(23,617 |
) |
|
$ |
30,839 |
|
|
$ |
(266,528 |
) |
|
$ |
(43,484 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net (loss)
income per share: |
|
|
|
|
|
|
|
Loss from continuing operations |
$ |
(0.70 |
) |
|
$ |
(1.88 |
) |
|
$ |
(7.83 |
) |
|
$ |
(4.33 |
) |
Income from discontinued operations |
— |
|
|
2.77 |
|
|
— |
|
|
3.06 |
|
Basic and diluted net (loss)
income per share |
$ |
(0.70 |
) |
|
$ |
0.89 |
|
|
$ |
(7.83 |
) |
|
$ |
(1.27 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used to compute net (loss) income per share (basic and
diluted) |
33,906 |
|
|
34,492 |
|
|
34,058 |
|
|
34,339 |
|
AMAG
Pharmaceuticals, Inc.Condensed Consolidated
Balance Sheets(Unaudited, amounts in
thousands)
|
September 30, 2019 |
|
December 31, 2018 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
119,800 |
|
|
$ |
253,256 |
|
Marketable securities |
71,744 |
|
|
140,915 |
|
Accounts receivable, net |
77,588 |
|
|
75,347 |
|
Inventories |
28,644 |
|
|
26,691 |
|
Prepaid and other current assets |
43,063 |
|
|
18,961 |
|
Note receivable |
— |
|
|
10,000 |
|
Total current assets |
340,839 |
|
|
525,170 |
|
Property and equipment,
net |
7,912 |
|
|
7,521 |
|
Goodwill |
422,513 |
|
|
422,513 |
|
Intangible assets, net |
187,577 |
|
|
217,033 |
|
Operating lease right-of-use
asset |
6,642 |
|
|
— |
|
Deferred tax assets |
630 |
|
|
1,260 |
|
Restricted cash |
495 |
|
|
495 |
|
Other long-term assets |
— |
|
|
1,467 |
|
Total assets |
$ |
966,608 |
|
|
$ |
1,175,459 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
26,554 |
|
|
$ |
14,487 |
|
Accrued expenses |
172,285 |
|
|
129,537 |
|
Current portion of convertible notes, net |
— |
|
|
21,276 |
|
Current portion of operating lease liability |
3,994 |
|
|
— |
|
Current portion of deferred revenue |
1,128 |
|
|
— |
|
Current portion of acquisition-related contingent
consideration |
113 |
|
|
144 |
|
Total current liabilities |
204,074 |
|
|
165,444 |
|
Long-term liabilities: |
|
|
|
Convertible notes, net |
273,124 |
|
|
261,933 |
|
Long-term operating lease liability |
3,344 |
|
|
— |
|
Long-term deferred revenue |
5,171 |
|
|
— |
|
Long-term acquisition-related contingent consideration |
180 |
|
|
215 |
|
Other long-term liabilities |
87 |
|
|
1,212 |
|
Total liabilities |
485,980 |
|
|
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; 33,915,509 and 34,606,760 shares issued and outstanding
at September 30, 2019 and December 31, 2018, respectively |
339 |
|
|
346 |
|
Additional paid-in capital |
1,292,458 |
|
|
1,292,736 |
|
Accumulated other comprehensive loss |
(3,199 |
) |
|
(3,985 |
) |
Accumulated deficit |
(808,970 |
) |
|
(542,442 |
) |
Total stockholders’ equity |
480,628 |
|
|
746,655 |
|
Total liabilities and stockholders’ equity |
$ |
966,608 |
|
|
$ |
1,175,459 |
|
AMAG
Pharmaceuticals, Inc.Condensed Consolidated
Statements of Cash Flows(Unaudited, amounts in
thousands)
|
Nine Months Ended September 30, |
|
2019 |
|
2018 |
Cash flows from operating
activities: |
|
|
|
Net loss |
$ |
(266,528 |
) |
|
$ |
(43,484 |
) |
Adjustments to reconcile net
loss to net cash (used in) provided by operating activities: |
|
|
|
Depreciation and amortization |
13,871 |
|
|
158,002 |
|
Impairment of intangible assets |
77,358 |
|
|
— |
|
Provision for bad debt expense |
(12 |
) |
|
754 |
|
Amortization of premium/discount on purchased securities |
(64 |
) |
|
96 |
|
Write-down of inventory |
4,872 |
|
|
— |
|
Gain on disposal of fixed assets |
— |
|
|
(99 |
) |
Non-cash equity-based compensation expense |
14,381 |
|
|
14,599 |
|
Non-cash IPR&D expense |
18,029 |
|
|
— |
|
Loss on debt extinguishment |
— |
|
|
35,922 |
|
Amortization of debt discount and debt issuance costs |
11,332 |
|
|
11,824 |
|
Gains on marketable securities, net |
(263 |
) |
|
(1 |
) |
Change in fair value of contingent consideration |
(16 |
) |
|
(49,175 |
) |
Deferred income taxes |
408 |
|
|
43,747 |
|
Gain on sale of the CBR business |
— |
|
|
(89,581 |
) |
Transaction costs |
— |
|
|
(14,111 |
) |
Changes in operating assets
and liabilities: |
|
|
|
Accounts receivable, net |
(2,229 |
) |
|
7,175 |
|
Inventories |
(6,824 |
) |
|
3,587 |
|
Prepaid and other current assets |
(24,075 |
) |
|
1,101 |
|
Accounts payable and accrued expenses |
53,092 |
|
|
(4,280 |
) |
Deferred revenues |
(101 |
) |
|
8,658 |
|
Other assets and liabilities |
1,038 |
|
|
159 |
|
Net cash (used in) provided by operating activities |
(105,731 |
) |
|
84,893 |
|
Cash flows from investing
activities: |
|
|
|
Proceeds from sales or maturities of marketable securities |
85,321 |
|
|
60,146 |
|
Purchase of marketable securities |
(14,815 |
) |
|
(64,400 |
) |
Milestone payment for Vyleesi developed technology |
(60,000 |
) |
|
— |
|
Proceeds from the sale of the CBR business |
— |
|
|
519,303 |
|
Capital expenditures |
(2,098 |
) |
|
(1,913 |
) |
Net cash provided by investing activities |
8,408 |
|
|
513,136 |
|
Cash flows from financing
activities: |
|
|
|
Long-term debt principal payments |
— |
|
|
(475,000 |
) |
Payments to settle convertible notes |
(21,417 |
) |
|
— |
|
Payment of premium on debt extinguishment |
— |
|
|
(28,054 |
) |
Payments of contingent consideration |
(50 |
) |
|
(87 |
) |
Payments for repurchases of common stock |
(13,730 |
) |
|
— |
|
Proceeds from the issuance of common stock under the ESPP |
851 |
|
|
— |
|
Proceeds from the exercise of common stock options |
30 |
|
|
2,635 |
|
Payments of employee tax withholding related to equity-based
compensation |
(1,817 |
) |
|
(2,632 |
) |
Net cash used in financing activities |
(36,133 |
) |
|
(503,138 |
) |
Net (decrease) increase in
cash, cash equivalents, and restricted cash |
(133,456 |
) |
|
94,891 |
|
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 |
$ |
120,295 |
|
|
$ |
287,661 |
|
Supplemental data for cash
flow information: |
|
|
|
Cash paid for taxes |
$ |
456 |
|
|
$ |
5,041 |
|
Cash paid for interest |
$ |
5,467 |
|
|
$ |
43,546 |
|
Non-cash investing and
financing activities: |
|
|
|
Settlement of note receivable in connection with Perosphere
acquisition |
$ |
10,000 |
|
|
$ |
— |
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended
September 30, 2019(Unaudited, amounts in
thousands)
|
Revenue |
|
Cost ofproduct sales |
|
Research &development |
|
Selling,general &administrative |
|
AcquiredIPR&D |
|
OperatingLoss /AdjustedEBITDA |
GAAP |
$ |
84,131 |
|
|
$ |
21,105 |
|
|
$ |
15,330 |
|
|
$ |
65,720 |
|
|
$ |
— |
|
|
$ |
(18,024 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(4,212 |
) |
|
(126 |
) |
|
(445 |
) |
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(225 |
) |
|
(691 |
) |
|
(4,058 |
) |
|
— |
|
|
|
Non-GAAP
Adjusted |
$ |
84,131 |
|
|
$ |
16,668 |
|
|
$ |
14,513 |
|
|
$ |
61,217 |
|
|
$ |
— |
|
|
$ |
(8,267 |
) |
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended
September 30, 2018(Unaudited, amounts in
thousands)
|
Revenue |
|
Cost ofproduct sales |
|
Research &development |
|
Selling,general &administrative |
|
AcquiredIPR&D |
|
OperatingLoss /AdjustedEBITDA |
GAAP |
$ |
122,238 |
|
|
$ |
46,489 |
|
|
$ |
10,133 |
|
|
$ |
72,451 |
|
|
$ |
12,500 |
|
|
$ |
(19,335 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(30,945 |
) |
|
(6 |
) |
|
(456 |
) |
|
— |
|
|
|
Non-cash inventory step-up
adjustments |
— |
|
|
(412 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(281 |
) |
|
(568 |
) |
|
(4,202 |
) |
|
— |
|
|
|
Adjustments to contingent
consideration |
— |
|
|
— |
|
|
— |
|
|
(9 |
) |
|
— |
|
|
|
Acquired IPR&D |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(12,500 |
) |
|
|
Non-GAAP
Adjusted |
$ |
122,238 |
|
|
$ |
14,851 |
|
|
$ |
9,559 |
|
|
$ |
67,784 |
|
|
$ |
— |
|
|
$ |
30,044 |
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsNine Months Ended
September 30, 2019(Unaudited, amounts in
thousands)
|
Revenue |
|
Cost ofproductsales |
|
Research &development |
|
Selling,general &administrative |
|
AcquiredIPR&D |
|
Restructuring |
|
Intangibleassetimpairmentcharge |
|
OperatingLoss /AdjustedEBITDA |
GAAP |
$ |
238,043 |
|
|
$ |
63,871 |
|
|
$ |
48,377 |
|
|
$ |
217,727 |
|
|
$ |
74,856 |
|
|
$ |
7,420 |
|
|
$ |
77,358 |
|
|
$ |
(251,566 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(12,097 |
) |
|
(471 |
) |
|
(1,304 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(626 |
) |
|
(2,051 |
) |
|
(11,039 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Acquisition-related costs |
— |
|
|
— |
|
|
— |
|
|
(270 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Acquired IPR&D |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(74,856 |
) |
|
— |
|
|
— |
|
|
|
Restructuring |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(7,420 |
) |
|
— |
|
|
|
Asset impairment charges |
— |
|
|
(4,836 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(77,358 |
) |
|
|
Non-GAAP
Adjusted |
$ |
238,043 |
|
|
$ |
46,312 |
|
|
$ |
45,855 |
|
|
$ |
205,114 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(59,238 |
) |
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsNine Months Ended
September 30, 2018(Unaudited, amounts in
thousands)
|
Revenue |
|
Cost ofproduct sales |
|
Research &development |
|
Selling, general& administrative |
|
AcquiredIPR&D |
|
OperatingLoss /AdjustedEBITDA |
GAAP |
$ |
385,881 |
|
|
$ |
187,176 |
|
|
$ |
32,635 |
|
|
$ |
161,780 |
|
|
$ |
32,500 |
|
|
$ |
(28,210 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(144,732 |
) |
|
(12 |
) |
|
(1,220 |
) |
|
— |
|
|
|
Non-cash inventory step-up
adjustments |
— |
|
|
(3,602 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(588 |
) |
|
(1,896 |
) |
|
(12,149 |
) |
|
— |
|
|
|
Adjustments to contingent
consideration |
— |
|
|
— |
|
|
— |
|
|
49,175 |
|
|
— |
|
|
|
Acquired IPR&D |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(32,500 |
) |
|
|
Non-GAAP
Adjusted |
$ |
385,881 |
|
|
$ |
38,254 |
|
|
$ |
30,727 |
|
|
$ |
197,586 |
|
|
$ |
— |
|
|
$ |
119,314 |
|
AMAG
Pharmaceuticals, Inc.Reconciliation of GAAP
to Non-GAAP 2019 Financial Guidance(Unaudited,
amounts in millions)
|
Updated 2019Financial Guidance |
Previous 2019Financial Guidance |
Operating
loss |
($278) - ($268) |
($286) - ($276) |
Depreciation & intangible
asset amortization |
20 |
18 |
Stock-based compensation |
19 |
19 |
Acquired IPR&D |
75 |
75 |
Restructuring |
7 |
7 |
Asset impairment charges |
82 |
82 |
Non-GAAP adjusted EBITDA |
($75) - ($65) |
($85) - ($75) |
AMAG
Pharmaceuticals, Inc.Share Count
Reconciliation(Unaudited, amounts in
millions)
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Weighted avg. basic and diluted shares
outstanding |
|
33.9 |
|
|
34.5 |
|
|
34.1 |
|
|
34.3 |
|
|
Employee equity incentive awards |
|
— |
|
4 |
0.5 |
|
5 |
— |
|
4 |
0.3 |
|
5 |
Non-GAAP diluted
shares outstanding |
|
33.9 |
|
|
35.0 |
|
|
34.1 |
|
|
34.6 |
|
|
4 Employee equity incentive awards would be anti-dilutive in
this period.5 Reflects the non-GAAP dilutive impact of employee
equity incentive awards.
CONTACT:AMAG PharmaceuticalsLinda
Lennox908-627-3424
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