AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited
consolidated financial results for the second quarter ended
June 30, 2020. The company reported total revenues for the
second quarter of 2020 of $52.8 million, including revenue of $29.6
million from Feraheme® (ferumoxytol injection) and revenue of $22.3
million from Makena® (hydroxyprogesterone caproate injection). The
company also reported an operating loss of $7.0 million and an
adjusted EBITDA loss of $1.7 million in the second quarter of
2020.1
"Amidst the unprecedented uncertainty that COVID-19 placed on
the healthcare system and our economy, AMAG's marketed therapeutics
performed well in the second quarter due in part to our teams'
ability to adapt in a rapidly-changing environment," said Scott
Myers, AMAG's Chief Executive Officer. "Over the past three
months, we have advanced the company's strategic evolution by
reaching important milestones that include a strategic, ex-US
partnership with Norgine to further progress ciraparantag and
strengthen our company's ability to invest in our pipeline.
We have also streamlined expenses by completing the divestment of
Intrarosa® and Vyleesi® and making changes to our portfolio
designed to further focus on programs with the highest potential to
deliver innovative treatments for patients and unlock shareholder
value."
2020 FINANCIAL GUIDANCE
($M) |
|
2020 Financial Guidance2 |
Total revenue |
|
$225 - $255 |
Operating loss |
|
$(40) - $(15) |
Non-GAAP Adjusted EBITDA3 |
|
$(5) - $20 |
"Strong execution across our portfolio throughout the COVID-19
pandemic allows us to reissue financial guidance that reflects the
relative stability of Makena over the quarter and the momentum that
Feraheme began to build in June, which saw record highs in monthly
share and ex-factory volume," said Brian Piekos, Chief Financial
Officer. "The guidance we are sharing today is designed to
prioritize investments that will drive long-term growth while also
putting us on track to return to positive adjusted EBITDA."
PORTFOLIO UPDATES Ciraparantag
(AMAG-977) – As previously announced, AMAG has completed
an exclusive licensing agreement with Norgine, a leading European
specialist pharmaceutical company, to develop and commercialize
ciraparantag in Europe, Australia and New Zealand. Through this
agreement, AMAG has received a total of $30 million in upfront
consideration and could receive up to $260 million in future
contingent development and commercial milestones4 together with
escalating double-digit royalties. Additionally, Norgine has
committed to contribute one-third of the costs of the Phase 3
clinical program, which would be conducted by AMAG to support
regulatory approval of ciraparantag by the U.S. Food and Drug
Administration, the European Medicines Agency, and the Medicines
and Healthcare Products Regulatory Agency. AMAG will continue to
oversee the Phase 3 clinical program, while working closely with
Norgine to develop and execute a global development strategy. The
company believes this partnership will unlock value in ciraparantag
and further strengthen AMAG’s ability to continue investing in
innovative therapies that address urgent unmet medical
needs.
On July 12, AMAG presented a poster of data titled “Efficacy and
Safety of Ciraparantag in Reversing Apixaban and Rivaroxaban in
Healthy Adults” at the 2020 International Society on Thrombosis and
Haemostatis (ISTH) virtual annual meeting. This presentation
shared data from two Phase 2 randomized, placebo-controlled, dose
ranging studies which showed safety and efficacy of ciraparantag
reversing the effects of apixaban and rivaroxaban in healthy adults
age 50-75 years. Results from both studies, which randomized a
total of 113 subjects, showed that steady-state anticoagulation
induced by apixaban or rivaroxaban was reversed by a single IV
infusion of ciraparantag in a dose-related manner as assessed by
whole blood clotting time (WBCT).
AMAG-423 – The AMAG-423 Phase 2b/3a study was
designed to explore a potential treatment for severe preeclampsia,
a serious medical condition that impacts about 50,000 women in the
US each year. As previously disclosed, the small population
of eligible patients made the study difficult to enroll. The
COVID-19 pandemic has led to a global pause for various clinical
research projects across therapeutic areas, including the AMAG-423
Phase 2b/3a study. In light of these extended and ongoing delays to
study completion, AMAG decided to conduct an interim analysis with
data from 55 subjects to validate original study assumptions that
were based on the 51-subject proof-of-concept DEEP study completed
in 2007. In order to continue keeping AMAG blinded to study
treatment assignments, the independent Data and Safety Monitoring
Board (DSMB) was tasked with conducting the interim analysis.
Following this interim analysis, the DSMB provided a unanimous
recommendation to stop the study, based upon the low likelihood
that future enrollment would demonstrate a benefit of AMAG-423 in
women with severe preeclampsia. Importantly, there were no
safety concerns raised during this study. AMAG has accepted
the DSMB’s recommendation to stop the study and is currently
focused on ensuring an appropriate closeout of the study in
partnership with investigators and other relevant stakeholders.
Divestiture of Intrarosa® and Vyleesi® – As
previously announced, AMAG has completed the divestment of
Intrarosa® and Vyleesi® which reduces operating expenses and allows
the company to focus on optimizing its marketed assets and
developing its innovative pipeline.
CORPORATE UPDATESLeadership
Appointments - The company has appointed Brian Piekos as
its Chief Financial Officer, effective as of August 13, 2020.
Mr. Piekos has served as interim CFO since June 2020 after holding
several senior management positions since joining AMAG in
2015.
SECOND QUARTER ENDED JUNE
30RevenueSecond quarter revenue totaled
$52.8 million, compared to $77.8 million for the same period in
2019. This decrease was due to the negative impact of
COVID-19 and the October 2019 unfavorable FDA Advisory Committee
recommendation on Makena.
- Feraheme achieved second quarter revenue of $29.6 million, a
decrease of 30 percent over the same period last year. Feraheme’s
average quarterly market share was 17.3 percent in the second
quarter of 2020, compared to 17.2 percent in the second quarter of
2019.
- Makena second quarter revenue totaled $22.3 million, a decrease
of 27 percent over the same period last year. Makena’s
average quarterly market share was 66 percent in the second quarter
of 2020, compared to 63 percent in the second quarter of 2019.
($M) |
Three Months Ended June 30, |
|
|
2020 |
|
|
2019 |
Total
revenues |
$52.8 |
|
|
$77.8 |
Feraheme |
|
29.6 |
|
|
42.1 |
Makena |
|
22.3 |
|
|
30.6 |
Intrarosa |
|
1.2 |
|
|
4.9 |
Other |
|
(0.4 |
) |
|
0.2 |
Operating ExpensesTotal costs and expenses
decreased by $134.2 million to $59.8 million in the second
quarter of 2020, as compared to the second quarter of 2019.
- Cost of products sales in the second quarter of 2020 decreased
by $6.1 million, as compared with the second quarter of last
year. Direct cost of product sales for the three months ended
June 30, 2019 included a $4.8 million one-time inventory
write-down related to the Makena IM product. Excluding this
one-time inventory write-down, direct cost of product sales
declined in the second quarter of 2020 due to reduced Feraheme and
Makena sales and the divestment of Intrarosa.
- Research and development (R&D) expenses totaled $8.3
million, compared to $15.0 million in the first quarter of last
year. This decrease was primarily related to lower costs for
Vyleesi following FDA approval in 2019 and COVID-19 related delays
in clinical trials.
- Selling, general and administrative (SG&A) expenses
decreased by approximately $37.8 million, or 49 percent, in the
second quarter of 2020, compared to the same period in 2019. This
decrease was primarily due to decreases in marketing spend related
to women’s health assets and reduced compensation-related costs as
a result of the May 2020 restructuring.
($M) |
Three Months Ended June 30, |
|
|
2020 |
|
|
2019 |
Amortization of intangible assets |
$9.0 |
|
$3.9 |
Direct cost of product sales |
|
9.2 |
|
|
20.3 |
Total cost of product
sales |
|
18.2 |
|
|
24.2 |
Research and
development expenses |
|
8.3 |
|
|
15.0 |
Selling, general and
administrative expenses |
|
39.6 |
|
|
77.3 |
Impairment of
intangible assets |
|
— |
|
|
77.4 |
Gain on sale of
assets |
|
(14.4 |
) |
|
— |
Restructuring
expenses |
|
8.2 |
|
|
— |
Total costs and expenses |
$59.8 |
|
$194.0 |
Operating Loss and Adjusted EBITDA
- The company reported an operating loss of $7.0 million in the
second quarter of 2020, compared to an operating loss of $116.2
million in the same period last year.
- The company reported a loss in adjusted EBITDA of $1.7
million in the second quarter of 2020, compared to a loss in
adjusted EBITDA of $24.7 million in the same period last year.
($M) |
Three Months Ended June 30, |
|
|
2020 |
|
|
2019 |
|
Operating
loss |
$(7.0 |
) |
$(116.2 |
) |
Non-GAAP adjusted EBITDA5 |
$(1.7 |
) |
$(24.7 |
) |
The financial figures and statements referenced herein have been
adjusted to correct immaterial errors in Makena revenue in the
historical periods 2016 through the first quarter of 2020; in
aggregate, Makena revenue is reduced by $6.3 million over the
four-year period. This error was identified by the company
during the second quarter of 2020 and relates to the timely accrual
of certain governmental rebates. The company and our
independent auditors are still reviewing the prior period financial
statements and the potential impact on our internal controls over
financial reporting for the periods. Therefore, the
financials set forth in this release are preliminary and may be
updated in the company’s quarterly report on Form 10Q for the
quarter ended June 30, 2020. As a result, investors are
cautioned not to place undue reliance on these financial
statements.
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 second quarter 2020
financial results and recent business updates.
DIAL-IN NUMBERSU.S./Canada Dial-in Number: (877)
412-6083International Dial-in Number: (702) 495-1202Conference ID:
4548238
Replay Dial-in Number: (855) 859-2056Replay International
Dial-in Number: (404) 537-3406Conference ID: 4548238
A telephone replay will be available from approximately 11:00
a.m. ET on August 6, 2020 through midnight on August 20, 2020
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.
_______________________________1 See reconciliations of GAAP to
non-GAAP adjustments at the conclusion of this press release2 2020
Operating Loss financial guidance excludes the accounting impact of
the following subsequent events announced in July: termination of
the Vyleesi license agreement with Palatin and costs associated
with discontinuing the AMAG-423 program.3 See reconciliations of
2020 GAAP to non-GAAP financial guidance at the conclusion of this
press release.4 40.0 million of such milestones would be paid to
the former equity holders of Perosphere Pharmaceuticals
Inc. pursuant to the Agreement and Plan of Merger
with Perosphere.5 See reconciliations of GAAP to non-GAAP
adjustments at the conclusion of this press release.
ABOUT AMAGAMAG is a commercial stage
biopharmaceutical 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. 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, statements regarding the performance of AMAG’s
marketed therapeutics, including about the stability of Makena and
the momentum of Feraheme through the COVID-19 pandemic; beliefs
about the team’s adaptability, the benefits of and expectations for
recent business milestones, AMAG’s current pipeline and AMAG’s
ability to invest in such pipeline; plans to deliver innovative
treatments and unlock shareholder value; beliefs regarding the
impact, including on a go-forward basis, of the COVID-19 pandemic
on AMAG’s revenues, results of operations and overall business and
industry; expectations for the Norgine arrangement, including the
ability to unlock value in ciraparantag and invest in innovative
therapies; beliefs about AMAG-423; plans to use streamlined
operations and to optimize its pipeline; statements regarding 2020
financial guidance, including the expectation of achieving EBITDA
positive and the impact of recent events on such guidance, such as
the termination of the Palatin license agreement and costs
associated with discontinuing the AMAG-423 trial, and statements
about AMAG’s ability to deliver long-term growth 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, risks and
uncertainties related to the scale and scope of the COVID-19
pandemic and its impact on AMAG’s revenues and operations,
including clinical trials, as well as COVID-19’s impact on AMAG’s
business partners, healthcare providers, patients, employees and
the health care industry and worldwide economies generally, risks
related to AMAG’s ability to manage the recently streamlined
business and achieve anticipated results in a timely manner or at
all, including any unintended consequences from such efforts; the
possibility that AMAG’s independent auditors will identify a
material weakness as part of their review stemming from the
immaterial accounting errors, or that they will identify other
errors or corrections, including errors or corrections that could
materially impact our financial statements and results provided in
this press release; the accounting impact of AMAG’s recent business
development activity could have an impact on 2020 guidance; revenue
expectations and estimates may be inaccurate, including as a result
of regulatory action with respect to Makena or due to COVID-19,
AMAG may not successfully develop and obtain approval for
ciraparantag or may face challenges in supporting its relationship
with Norgine, 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,
2019, its Current Reports on Form 8-K, its Quarterly Reports on
Form 10-Q, including for the quarter ended March 31, 2020, and in
any subsequent filings with the SEC, including AMAG’s upcoming Form
10-Q for the quarter ended June 30, 2020 , 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 logo and designs, and Feraheme® are
registered trademarks of AMAG Pharmaceuticals, Inc.
Makena® is a registered trademark of AMAG Pharma USA, Inc.
Any other trademarks referred to 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 June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues: |
|
|
|
|
|
|
|
Feraheme |
$ |
29,635 |
|
|
$ |
42,074 |
|
|
$ |
74,068 |
|
|
$ |
82,089 |
|
Makena |
22,325 |
|
|
30,593 |
|
|
45,888 |
|
|
61,534 |
|
Intrarosa |
1,216 |
|
|
4,877 |
|
|
4,385 |
|
|
9,291 |
|
Other |
(447 |
) |
|
90 |
|
|
(1,199 |
) |
|
133 |
|
Total product revenues |
52,729 |
|
|
77,634 |
|
|
123,142 |
|
|
153,047 |
|
Other revenues |
26 |
|
|
133 |
|
|
58 |
|
|
208 |
|
Total revenues |
52,755 |
|
|
77,767 |
|
|
123,200 |
|
|
153,255 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of product sales |
18,180 |
|
|
24,290 |
|
|
42,539 |
|
|
42,767 |
|
Research and development expenses |
8,263 |
|
|
14,980 |
|
|
19,443 |
|
|
33,046 |
|
Acquired in-process research and development |
— |
|
|
— |
|
|
— |
|
|
74,856 |
|
Selling, general and administrative expenses |
39,568 |
|
|
77,324 |
|
|
92,266 |
|
|
152,006 |
|
Impairment of intangible assets |
— |
|
|
77,358 |
|
|
— |
|
|
77,358 |
|
Gain on sale of assets |
(14,444 |
) |
|
— |
|
|
(14,444 |
) |
|
— |
|
Restructuring expenses |
8,197 |
|
|
— |
|
|
8,197 |
|
|
7,420 |
|
Total costs and expenses |
59,764 |
|
|
193,952 |
|
|
148,001 |
|
|
387,453 |
|
Operating loss |
(7,009 |
) |
|
(116,185 |
) |
|
(24,801 |
) |
|
(234,198 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest expense |
(6,700 |
) |
|
(6,330 |
) |
|
(13,303 |
) |
|
(12,780 |
) |
Interest and dividend income |
327 |
|
|
1,224 |
|
|
804 |
|
|
2,810 |
|
Other (expense) income |
(22 |
) |
|
2 |
|
|
1,288 |
|
|
342 |
|
Total other expense, net |
(6,395 |
) |
|
(5,104 |
) |
|
(11,211 |
) |
|
(9,628 |
) |
Loss before income taxes |
(13,404 |
) |
|
(121,289 |
) |
|
(36,012 |
) |
|
(243,826 |
) |
Income tax benefit |
(160 |
) |
|
(120 |
) |
|
(60 |
) |
|
(257 |
) |
Net loss |
$ |
(13,244 |
) |
|
$ |
(121,169 |
) |
|
$ |
(35,952 |
) |
|
$ |
(243,569 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
$ |
(0.39 |
) |
|
$ |
(3.58 |
) |
|
$ |
(1.05 |
) |
|
$ |
(7.14 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used to compute net loss per share (basic and
diluted) |
34,353 |
|
|
33,807 |
|
|
34,228 |
|
|
34,136 |
|
AMAG
Pharmaceuticals, Inc.Condensed Consolidated
Balance Sheets(Unaudited, amounts in
thousands)
|
June 30, 2020 |
|
December 31, 2019 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
98,521 |
|
|
$ |
113,009 |
|
Marketable securities |
48,594 |
|
|
58,742 |
|
Accounts receivable, net |
65,104 |
|
|
94,163 |
|
Inventories |
30,388 |
|
|
31,553 |
|
Prepaid and other current assets |
20,950 |
|
|
19,100 |
|
Total current assets |
263,557 |
|
|
316,567 |
|
Property and equipment,
net |
3,031 |
|
|
4,116 |
|
Goodwill |
422,513 |
|
|
422,513 |
|
Intangible assets, net |
3,946 |
|
|
23,620 |
|
Operating lease right-of-use
asset |
22,007 |
|
|
23,286 |
|
Deferred tax assets |
— |
|
|
630 |
|
Restricted cash |
495 |
|
|
495 |
|
Total assets |
$ |
715,549 |
|
|
$ |
791,227 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
12,944 |
|
|
$ |
27,021 |
|
Accrued expenses |
144,567 |
|
|
183,382 |
|
Current portion of operating lease liability |
3,488 |
|
|
4,077 |
|
Current portion of acquisition-related contingent
consideration |
— |
|
|
17 |
|
Total current liabilities |
160,999 |
|
|
214,497 |
|
Long-term liabilities: |
|
|
|
Convertible notes, net |
285,137 |
|
|
277,034 |
|
Long-term operating lease liability |
19,263 |
|
|
19,791 |
|
Other long-term liabilities |
828 |
|
|
89 |
|
Total liabilities |
466,227 |
|
|
511,411 |
|
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; 34,463,373 and 33,999,081 shares issued and outstanding
at June 30, 2020 and December 31, 2019, respectively |
344 |
|
|
339 |
|
Additional paid-in capital |
1,303,095 |
|
|
1,297,917 |
|
Accumulated other comprehensive loss |
(2,964 |
) |
|
(3,239 |
) |
Accumulated deficit |
(1,051,153 |
) |
|
(1,015,201 |
) |
Total stockholders’ equity |
249,322 |
|
|
279,816 |
|
Total liabilities and stockholders’ equity |
$ |
715,549 |
|
|
$ |
791,227 |
|
AMAG
Pharmaceuticals, Inc.Condensed Consolidated
Statements of Cash Flows(Unaudited, amounts in
thousands)
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
Cash flows from operating
activities: |
|
|
|
Net loss |
$ |
(35,952 |
) |
|
$ |
(243,569 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
Depreciation and amortization |
19,791 |
|
|
9,089 |
|
Impairment of intangible assets |
— |
|
|
77,358 |
|
Provision for bad debt expense |
230 |
|
|
(12 |
) |
Amortization of premium/discount on purchased securities |
42 |
|
|
(51 |
) |
Write-down of inventory |
616 |
|
|
4,836 |
|
(Gain)/loss on disposal of property & equipment |
230 |
|
|
— |
|
Non-cash equity-based compensation expense |
5,879 |
|
|
9,407 |
|
Non-cash IPR&D expense |
— |
|
|
18,029 |
|
Amortization of debt discount and debt issuance costs |
8,103 |
|
|
7,513 |
|
Gains on marketable securities, net |
(10 |
) |
|
(270 |
) |
Change in fair value of contingent consideration |
— |
|
|
(21 |
) |
Deferred income taxes |
630 |
|
|
630 |
|
Non-cash lease expense |
1,279 |
|
|
— |
|
Gain on sale of assets |
(15,853 |
) |
|
— |
|
Changes in operating assets
and liabilities: |
|
|
|
Accounts receivable, net |
28,828 |
|
|
(7,825 |
) |
Inventories |
(872 |
) |
|
(3,323 |
) |
Prepaid and other current assets |
(1,790 |
) |
|
(5,562 |
) |
Accounts payable and accrued expenses |
(53,494 |
) |
|
36,137 |
|
Deferred revenues |
— |
|
|
(101 |
) |
Other assets and liabilities |
(377 |
) |
|
1,283 |
|
Net cash used in operating activities |
(42,720 |
) |
|
(96,452 |
) |
Cash flows from investing
activities: |
|
|
|
Proceeds from sales or maturities of marketable securities |
33,735 |
|
|
46,420 |
|
Purchase of marketable securities |
(23,345 |
) |
|
(14,815 |
) |
Net proceeds from the sale of assets |
19,344 |
|
|
— |
|
Capital expenditures |
(790 |
) |
|
(1,907 |
) |
Net cash provided by investing activities |
28,944 |
|
|
29,698 |
|
Cash flows from financing
activities: |
|
|
|
Payments to settle convertible notes |
— |
|
|
(21,417 |
) |
Payments of contingent consideration |
(17 |
) |
|
(27 |
) |
Payments for repurchases of common stock |
— |
|
|
(13,730 |
) |
Proceeds from the issuance of common stock under the ESPP |
631 |
|
|
851 |
|
Proceeds from the exercise of common stock options |
— |
|
|
30 |
|
Payments of employee tax withholding related to equity-based
compensation |
(1,326 |
) |
|
(1,748 |
) |
Net cash used in financing activities |
(712 |
) |
|
(36,041 |
) |
Net decrease in cash, cash
equivalents, and restricted cash |
(14,488 |
) |
|
(102,795 |
) |
Cash, cash equivalents, and
restricted cash at beginning of the period |
113,504 |
|
|
253,751 |
|
Cash, cash equivalents, and
restricted cash at end of the period |
$ |
99,016 |
|
|
$ |
150,956 |
|
Supplemental data for cash
flow information: |
|
|
|
Cash (refunded) paid for taxes |
$ |
(256 |
) |
|
$ |
433 |
|
Cash paid for interest |
$ |
5,200 |
|
|
$ |
5,467 |
|
Non-cash investing and
financing activities: |
|
|
|
Milestone payment accrued for FDA approval of Vyleesi |
$ |
— |
|
|
$ |
60,000 |
|
Settlement of note receivable in connection with Perosphere
acquisition |
$ |
— |
|
|
$ |
10,000 |
|
Right-of-use assets obtained in exchange for lease liabilities |
$ |
— |
|
|
$ |
918 |
|
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended June
30, 2020 (Unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Research & development |
|
Selling, general & administrative |
|
Gain on sale of assets |
|
Restructuring |
|
Operating Loss / Adjusted EBITDA |
GAAP |
$ |
52,755 |
|
|
$ |
18,180 |
|
|
$ |
8,263 |
|
|
$ |
39,568 |
|
|
$ |
(14,444 |
) |
|
$ |
8,197 |
|
|
$ |
(7,009 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(8,961 |
) |
|
(74 |
) |
|
(438 |
) |
|
— |
|
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(104 |
) |
|
48 |
|
|
(2,037 |
) |
|
— |
|
|
— |
|
|
|
Gain on sale of assets |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
14,444 |
|
|
— |
|
|
|
Restructuring |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(8,197 |
) |
|
|
Non-GAAP
Adjusted |
$ |
52,755 |
|
|
$ |
9,115 |
|
|
$ |
8,237 |
|
|
$ |
37,093 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(1,690 |
) |
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsThree Months Ended June
30, 2019(Unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Research & development |
|
Selling, general & administrative |
|
Intangible asset impairment charge |
|
Operating Loss / Adjusted EBITDA |
GAAP |
$ |
77,767 |
|
|
$ |
24,290 |
|
|
$ |
14,980 |
|
|
$ |
77,324 |
|
|
$ |
77,358 |
|
|
$ |
(116,185 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(3,943 |
) |
|
(336 |
) |
|
(434 |
) |
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(199 |
) |
|
(680 |
) |
|
(3,656 |
) |
|
— |
|
|
|
Asset impairment |
— |
|
|
(4,836 |
) |
|
— |
|
|
— |
|
|
(77,358 |
) |
|
|
Non-GAAP
Adjusted |
$ |
77,767 |
|
|
$ |
15,312 |
|
|
$ |
13,964 |
|
|
$ |
73,234 |
|
|
$ |
— |
|
|
$ |
(24,743 |
) |
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsSix Months Ended June 30,
2020 (Unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Research & development |
|
Selling, general & administrative |
|
Gain on sale of assets |
|
Restructuring |
|
Operating Loss / Adjusted EBITDA |
GAAP |
$ |
123,200 |
|
|
$ |
42,539 |
|
|
$ |
19,443 |
|
|
$ |
92,266 |
|
|
$ |
(14,444 |
) |
|
$ |
8,197 |
|
|
$ |
(24,801 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(18,798 |
) |
|
(150 |
) |
|
(843 |
) |
|
— |
|
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(307 |
) |
|
(23 |
) |
|
(5,549 |
) |
|
— |
|
|
— |
|
|
|
Gain on sale of assets |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
14,444 |
|
|
— |
|
|
|
Restructuring |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(8,197 |
) |
|
|
Non-GAAP
Adjusted |
$ |
123,200 |
|
|
$ |
23,434 |
|
|
$ |
19,270 |
|
|
$ |
85,874 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(5,378 |
) |
AMAG
Pharmaceuticals, Inc.Reconciliation of
Condensed Consolidated Statements of Operations to Non-GAAP
Statements of OperationsSix Months Ended June 30,
2019 (Unaudited, amounts in
thousands)
|
Revenue |
|
Cost of product sales |
|
Research & development |
|
Selling, general & administrative |
|
Acquired IPR&D |
|
Intangible asset impairment charge |
|
Restructuring |
|
Operating Loss / Adjusted EBITDA |
GAAP |
$ |
153,255 |
|
|
$ |
42,767 |
|
|
$ |
33,046 |
|
|
$ |
152,006 |
|
|
$ |
74,856 |
|
|
$ |
77,358 |
|
|
$ |
7,420 |
|
|
$ |
(234,198 |
) |
Depreciation and intangible
asset amortization |
— |
|
|
(7,886 |
) |
|
(345 |
) |
|
(858 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Stock-based compensation |
— |
|
|
(401 |
) |
|
(1,360 |
) |
|
(6,981 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Acquisition-related costs |
— |
|
|
— |
|
|
— |
|
|
(270 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
Asset impairment |
— |
|
|
(4,836 |
) |
|
— |
|
|
— |
|
|
— |
|
|
(77,358 |
) |
|
— |
|
|
|
Restructuring |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(7,420 |
) |
|
|
Acquired IPR&D |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(74,856 |
) |
|
— |
|
|
— |
|
|
|
Non-GAAP
Adjusted |
$ |
153,255 |
|
|
$ |
29,644 |
|
|
$ |
31,341 |
|
|
$ |
143,897 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(51,627 |
) |
AMAG
Pharmaceuticals, Inc.Reconciliation of GAAP
to Non-GAAP 2020 Financial Guidance(Unaudited,
amounts in thousands)
|
|
2020 Financial Guidance |
Operating
loss |
|
$(40) - $(15) |
Depreciation |
|
30.0 |
Stock-based compensation |
|
11.0 |
Gain on sale of assets |
|
(14.4) |
Restructuring |
|
8.2 |
Non-GAAP adjusted
EBITDA |
|
$(5) - $20 |
CONTACT:Rushmie Nofsinger781-530-6838
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