‒ Q1 2019 Net Revenue of $446 Million; GAAP
Loss per share of $0.37; Combined Adjusted Diluted EPS(1) of $0.14
‒
‒ Continued Progress in Diversifying Portfolio
and Optimizing Business ‒
‒ Reaffirming Full Year 2019 Financial Guidance
‒
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (the “Company”)
announced its results today for the first quarter ended
March 31, 2019.
Summary of GAAP and Non-GAAP Combined
and Adjusted Results
(Unaudited; In thousands, except per
share amounts)
Three
Months Ended
March 31,2019
March 31,2018
Year/ YearVariance
GAAP Results(2) Net revenue $ 446,120 $ 275,189 62.1
% Net (loss) income $ (124,752 ) $ 51,652
(341.5)
%
Diluted loss per share attributable to Amneal Pharmaceuticals, Inc.
$ (0.37 ) N/A N/A
Non-GAAP Results(1)(3)
Combined net revenue $ 446,120 $ 425,130 4.9 % Combined adjusted
net income $ 42,165 $ 41,846 0.8 % Combined adjusted EBITDA $
111,967 $ 95,880 16.8 % Combined adjusted diluted EPS
$ 0.14 $ 0.14 — %
(1) See “Non-GAAP Financial Measures” below.(2) GAAP results
prior to May 4, 2018 reflect the results of Amneal Pharmaceuticals
LLC only.(3) For March 31, 2018, assumes the combination between
Amneal Pharmaceuticals LLC and Impax Laboratories, LLC, and the
acquisition of Gemini Laboratories, LLC, excluding the impact of
financing and acquisition accounting adjustments, occurred on
January 1, 2018.
Executive Commentary
"Amneal is off to a good start in 2019 as we continue to
optimize our business and diversify our portfolio," said Rob
Stewart, President and CEO of Amneal. "We increased generics first
quarter combined net revenue(1) by 7% year over year driven by the
addition of Levothyroxine, the benefit of more than 40 product
launches last year and the launch of six new products this year. We
also took steps forward in our efforts to expand our portfolio into
complex dosage forms, highlighted by the approval and launch of our
first generic transdermal product, generic Exelon® Patch."
"We further sharpened our focus on our core business by
divesting our UK commercial business in late March and our German
business earlier this month. These portfolio moves enable us to
concentrate time and resources on growing our position in the U.S.
market. In addition, we strengthened our experienced management
team with the appointment of several key senior leaders who will
play important roles in optimizing our business to position Amneal
for sustainable, long-term growth."
"Looking ahead, we are continuing our focused efforts to
streamline our operations and accelerate savings as we drive
organic growth and pursue external growth opportunities. For the
remainder of the year, we expect to see improved profitability
through decreased spending within COGS, SG&A and R&D,
combined with an increase in revenues as new product launches
accelerate in the back half of the year."
Basis of Presentation
The Company's financial results are presented in accordance with
U.S. GAAP. As used in this press release, the term "actual" or
"reported"refers to measures under the accounting principles
generally accepted in the United States. The Company has two
reportable segments, Generics and Specialty, and does not allocate
general corporate services to either segment.
First Quarter 2019 Performance
Net revenue in the first quarter of 2019 was $446 million, an
increase of 62.1% compared to the prior year period, primarily due
to the combination with Impax and the acquisition of Gemini in May
2018, as well as the benefit of new generic product launches
throughout 2018 and into 2019. Net loss was $125 million in the
first quarter of 2019 compared to net income of $52 million in the
first quarter of 2018, primarily attributable to $76 million of
intangible asset impairment charges, incremental expenses related
to the combination with Impax and acquisition of Gemini, site
closure costs of $10 million and royalties of $21 million.
Additionally, the Company incurred $22 million of incremental
interest expense, $14 million of unfavorable foreign exchange
impact and $6 million of restructuring and other charges. Diluted
EPS in the first quarter of 2019 was a loss of $0.37. Diluted EPS
in the first quarter of 2018 is not available as Amneal
Pharmaceuticals LLC was a privately-held company for the period
presented.
Combined net revenue(1) in the first quarter of 2019 was $446
million, an increase of 4.9% compared to the prior year period, due
to an increase in net revenue from the Generics segment. Combined
adjusted net income(1) in the first quarter of 2019 was $42
million, an increase of 0.8% compared to the prior year period.
Combined adjusted EBITDA(1) in the first quarter of 2019 was $112
million, an increase of 16.8% compared to the prior year period.
The increase in combined adjusted EBITDA(1) was primarily due to
higher revenues and cost synergies from the combination with Impax.
Combined adjusted diluted EPS in the first quarter of 2019 was
$0.14, compared to $0.14 in the first quarter of 2018, primarily
due to higher revenues offset by incremental interest expense of
$12 million, net of tax, or approximately $0.04 per diluted share
in the current year period related to the combination with
Impax.
(1) See “Non-GAAP Financial Measures” below.
Amneal Pharmaceuticals, Inc.
Reconciliation of Generics Operating
(Loss) Income to Generics Combined Operating Loss
(Unaudited; In thousands)
Generics Three months ended March 31, 2019
Three months ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Net revenue - Generics $
382,477 $ — $ 382,477 $ 275,189 $ 81,242 $ 356,431 Cost of goods
sold 278,878 — 278,878 130,594 93,137 223,731 Cost of goods sold
impairment charges 53,297 —
53,297 — —
—
Gross profit 50,302 —
50,302 144,595 (11,895 )
132,700 Selling, general, and administrative
24,148 — 24,148 11,203 2,994 14,197 Research and development 50,151
— 50,151 44,209 9,639 53,848
In-process research and
developmentimpairment charges
22,787 — 22,787 — — — Restructuring and other charges 2,081 — 2,081
— — — Litigation, settlements and related charges — — — — 89,159
89,159 Intellectual property legal development expenses 3,121 —
3,121 4,576 23 4,599
Acquisition, integration and
transactionrelated expenses
2,597 — 2,597 —
— —
Operating
(loss) income $ (54,583 ) $ —
$ (54,583 ) $ 84,607 $ (113,710 )
$ (29,103 ) Gross margin 13.2 % 13.2 % 52.5 %
(14.6 %) 37.2 % Adjusted gross profit (Non-GAAP)(4) $ 162,276 $ — $
162,276 $ 146,355 $ 4,936 $ 151,291 Adjusted gross margin
(Non-GAAP)(5) 42.4 % — % 42.4 % 53.2 % 6.1 % 42.4 % Adjusted
operating income (Non-GAAP) $ 96,819 $ — $ 96,819 $ 87,463 $ (5,413
) $ 82,050
(4) Adjusted gross profit and combined adjusted gross profit are
calculated as net revenue less adjusted cost of goods sold. See
Non-GAAP reconciliations below for calculation of adjusted cost of
goods sold.(5) Adjusted gross margin is calculated as adjusted
gross profit divided by combined net revenue.
Generics net revenue of $382 million increased 39.0% for the
first quarter of 2019 compared to the prior year period. The
increase is primarily attributable to the combination with Impax,
the contribution from more than 40 new product launches throughout
2018 and six in 2019, and favorable volume growth driven by sales
of Levothyroxine, Guanfacine and Hydroproxyprogesterone Caproate
Injection, partially offset by declines in sales of Oseltamivir and
Aspirin Dipyridamole ER Capsules due to lower volumes and pricing
pressure. Generics combined net revenue(1) in the first quarter of
2019 was $382 million, an increase of 7.3% compared to the prior
year period, primarily due to favorable volume growth as noted
above.
Generics gross margin for the first quarter of 2019 was 13.2%
compared to 52.5% for the first quarter of 2018. The decrease was
primarily related to a $53 million impairment charge associated
with two marketed products as a result of significant price erosion
during the first quarter of 2019, due to new competition entering
the market, resulting in significantly lower expected future cash
flows from those products, $36 million of expenses related to the
Levothyroxine transition agreement with Lannett and incremental
expenses related to the combination with Impax, including royalties
of $21 million, site closure costs of $10 million, and amortization
of intangible assets of $9 million. Generics combined adjusted
gross margin(1) for the first quarter of 2019 was 42.4% compared to
42.4% for the first quarter of 2018.
Generics operating income for the first quarter of 2019 was a
loss of $55 million compared to operating income of $85 million for
the first quarter of 2018, primarily due to the charges and
expenses as noted above, as well as an additional $23 million of
in-process research and development impairment charges and $3
million of integration related expenses. Generics combined adjusted
operating income(1) for the first quarter of 2019 was $97 million,
an increase of 18.0% compared to $82 million in the prior year
period, primarily due to increased revenue as noted above.
(1) See “Non-GAAP Financial Measures” below.
Amneal Pharmaceuticals, Inc.
Reconciliation of Specialty Operating
Income to Specialty Combined Operating Income
(Unaudited; In thousands)
Specialty Three months ended March 31, 2019
Three months ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Net revenue - Specialty:
Rytary® $ 29,436 $ — $ 29,436 $ — $ 26,508 $ 26,508 Unithroid®
9,721 — 9,721 — 6,509 6,509 Zomig® 8,992 — 8,992 — 10,478 10,478
All other specialty products 15,494 —
15,494 — 25,204
25,204 Total net revenue - Specialty 63,643 —
63,643 — 68,699 68,699 Cost of goods sold 30,865
— 30,865 —
20,020 20,020
Gross profit
32,778 — 32,778 —
48,679 48,679
Selling, general, and administrative 21,327 — 21,327 — 20,235
20,235 Research and development 3,707 — 3,707 — 2,657 2,657
Intellectual property legal development expenses 1,045 — 1,045 — —
— Restructuring and other charges 178 — 178 — — — Litigation,
settlements and related charges — — — — 940 940
Acquisition, transaction-related
andintegration expenses
1,884 — 1,884 —
— —
Operating
income $ 4,637 $ — $
4,637 $ — $ 24,847
$ 24,847 Gross margin 51.5 % — 51.5 % — 70.9 % 70.9 %
Adjusted gross profit (Non-GAAP)(4) $ 52,989 $ — $ 52,989 $ — $
53,263 $ 53,263 Adjusted gross margin (Non-GAAP)(5) 83.3 % — % 83.3
% — % 77.5 % 77.5 % Adjusted operating income (Non-GAAP) $ 28,726 $
— $ 28,726 $ — $ 31,495 $ 31,495
(4) Adjusted gross profit and combined adjusted gross profit are
calculated as net revenue less adjusted cost of goods sold. See
Non-GAAP reconciliations below for calculation of adjusted cost of
goods sold.(5) Adjusted gross margin is calculated as adjusted
gross profit divided by combined net revenue.
The Specialty segment is comprised of the Impax Specialty
business acquired on May 4, 2018 and the Gemini Laboratories, LLC
business acquired on May 7, 2018. Prior to these two transactions,
Amneal did not have a Specialty segment.
Specialty combined net revenue(1) in the first quarter of 2019
was $64 million, a decrease of 7.4% compared to the prior year
period, driven primarily by lower revenue from Albenza® as a result
of the loss of exclusivity in September of 2018, partially offset
by higher revenue from Rytary® and Unithroid®.
Specialty combined gross margin(1) for the first quarter of 2019
was 51.5% compared to 70.9% for the prior year period, driven
primarily by higher amortization expense. Specialty combined
adjusted gross margin(5) was 83.3% for the first quarter of 2019
compared to 77.5% in the prior year period, primarily due to
product sales mix.
Specialty combined operating income(1) for the first quarter of
2019 was $5 million, a decrease of $20 million compared to the
prior year period, primarily due to higher amortization expenses
and lower revenue as noted above. Specialty combined adjusted
operating income(1) for the first quarter of 2019 was $29 million,
a decrease of $2 million compared to the prior year period,
primarily due to lower revenue.
(1) See “Non-GAAP Financial Measures” below
Corporate and Other Information
(Unaudited; In thousands)
Three months ended March 31, 2019 Three months
ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined General and administrative $ 38,961 $
— $ 38,961 $ 13,918 $ 20,737 $ 34,655
Acquisition, transaction-related
andintegration expenses
1,551 — 1,551 7,135 6,544 13,679 Restructuring and other charges
3,902 — 3,902 —
4,900 4,900
Total general, administrative andother
operating expenses
$ 44,414 $ — $ 44,414
$ 21,053 $ 32,181
$ 53,234
General and administrative and other operating expenses in the
first quarter of 2019 increased to $44 million compared to $21
million in the prior year period, primarily due to the combinations
with Impax and Gemini in 2018. General and administrative and other
operating expenses on a combined basis in the first quarter of 2019
decreased to $44 million compared to $53 million in the prior year
period, primarily due to lower acquisition, transaction-related and
integration expenses.
2019 Financial Outlook
Amneal’s full year 2019 estimates are based on management's
current expectations, including with respect to prescription
trends, pricing levels, inventory levels, and the anticipated
timing of future product launches and events. The Company cannot
provide a reconciliation between non-GAAP projections and the most
directly comparable GAAP measures without unreasonable efforts
because it is unable to predict with reasonable certainty the
ultimate outcome of certain significant items required for the
reconciliation. The items include, but are not limited to,
acquisition-related expenses, restructuring expenses, asset
impairments and other gains and losses. These items are uncertain,
depend on various factors, and could have a material impact on U.S.
GAAP reported results for 2019.
Amneal is reaffrming its previously provided 2019 Outlook as
follows:
Full
Year 2019 Financial Guidance Adjusted gross margin 47% - 50%
Adjusted R&D as a % of net revenue 9% - 10% Adjusted SG&A
as a % of net revenue 11% - 12% Adjusted EBITDA $600 million - $650
million Adjusted diluted EPS $0.94 - $1.04 Adjusted effective tax
rate 19% - 21% Capital expenditures Approximately $100 million
Weighted diluted shares outstanding
Approximately 300 million
Conference Call Information
Amneal will hold a conference call on May 9, 2019 at 8:30 a.m.
Eastern Time to discuss its results. The call and presentation can
also be accessed via a live Webcast through the Investor Relations
section of Amneal’s Web site at https://investors.amneal.com/investor-relations,
or directly at https://event.on24.com/wcc/r/1898588/19E7D09970ECDA91F9B21D94F3CEC0AB.
The number to call from within the United States is (866) 652-5200
and (412) 317-6060 internationally. A replay of the conference call
will be available shortly after the call for a period of seven
days. To access the replay, dial (877) 344-7529 (in the U.S.) and
(412) 317-0088 (international callers). The access code for the
replay is 10128077.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is an integrated pharmaceutical company focused on
developing, manufacturing and distributing generic, brand and
biosimilar products. The Company has approximately 6,000 employees
in its operations in North America, Asia, and Europe, working
together to bring high-quality medicines to patients primarily
within the United States.
Amneal is one of the largest and fastest growing generic
pharmaceutical manufacturers in the United States, with an
expanding portfolio of generic products to include complex dosage
forms in a broad range of therapeutic areas. The Company also
markets a portfolio of branded pharmaceutical products through its
Specialty segment focused principally on central nervous system
disorders and parasitic infections. For more information, visit
www.amneal.com.
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures,
including adjusted EBITDA, adjusted net income, adjusted net income
per diluted share, adjusted gross profit, adjusted gross margin and
adjusted operating income, which are intended as supplemental
measures of the Company’s performance that are not required by or
presented in accordance with GAAP. In addition, this release
includes these non-GAAP measures and our reported results on a
non-GAAP combined basis to include the historical results of Impax
and Gemini, not adjusted for financing and acquisition accounting
impacts of the combination, as if the transaction closing dates had
occurred on the first day of all periods presented herein. All
combined business results presented in this release are not
prepared in accordance with Article 11 of Regulation S-X. The
calculation of Non-GAAP adjusted diluted earnings per share assumes
the conversion of all outstanding shares of Class B Common Stock to
shares of Class A Common stock.
Management uses these non-GAAP historical and combined measures
internally to evaluate and manage the Company’s operations and to
better understand its business because they facilitate a
comparative assessment of the Company's operating performance
relative to its performance based on results calculated under GAAP.
These non-GAAP measures also isolate the effects of some items that
vary from period to period without any correlation to core
operating performance and eliminate certain charges that management
believes do not reflect the Company's operations and underlying
operational performance. The compensation committee of the
Company’s board of directors also uses certain of these measures to
evaluate management's performance and set its compensation. The
Company believes that these non-GAAP measures also provide useful
information to investors regarding certain financial and business
trends relating to the Company’s financial condition and operating
results, and doing so on a combined basis facilitates an evaluation
of the financial performance of the Company and its operations on a
consistent basis. Providing this information therefore allows
investors to make independent assessments of the Company’s
financial performance, results of operation and trends while
viewing the information through the eyes of management.
These non-GAAP measures are subject to limitations. The non-GAAP
measures presented in this release may not be comparable to
similarly titled measures used by other companies because other
companies may not calculate one or more in the same manner.
Additionally, the non-GAAP performance measures exclude significant
expenses and income that are required by GAAP to be recorded in the
Company’s financial statements; do not reflect changes in, or cash
requirements for, working capital needs; and do not reflect
interest expense, or the requirements necessary to service interest
or principal payments on debt. Further, the combined results may
not represent what our combined results of operations and financial
position would have been had the transactions occurred on the dates
indicated, nor are they intended to project our combined results of
operations or financial position for any future period. To
compensate for these limitations, management presents and considers
these non-GAAP measures in conjunction with the Company’s GAAP
results; no non-GAAP measure should be considered in isolation from
or as alternatives to net income, diluted earnings per share or any
other measure determined in accordance with GAAP. Readers should
review the reconciliations included below, and should not rely on
any single financial measure to evaluate the Company’s
business.
A reconciliation of each non-GAAP measure to the most directly
comparable GAAP measure is set forth below.
Safe Harbor Statement
Certain statements contained herein, regarding matters that are
not historical facts, may be forward-looking statements (as defined
in the Private Securities Litigation Reform Act of 1995). Such
forward-looking statements include statements regarding
management’s intentions, plans, beliefs, expectations or forecasts
for the future, including, among other things, future operating
results and financial performance, product development and
launches, integration strategies and resulting cost reduction,
market position and business strategy. Words such as “may,” “will,”
“could,” “expect,” “plan,” “anticipate,” “intend,” “believe,”
“estimate,” “assume,” “continue,” and similar words are intended to
identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. These forward-looking statements are based on current
expectations of future events. If the underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Amneal Pharmaceuticals, Inc. (the “Company”). Such
risks and uncertainties include, but are not limited to: the impact
of global economic conditions; our ability to integrate the
operations of Amneal Pharmaceuticals LLC and Impax Laboratories,
LLC pursuant to the business combination completed on May 4, 2018,
and our ability to realize the anticipated synergies and other
benefits of the combination; our ability to successfully develop
and commercialize new products; our ability to obtain exclusive
marketing rights for our products and to introduce products on a
timely basis; the competition we face in the pharmaceutical
industry from brand and generic drug product companies, and the
impact of that competition on our ability to set prices; our
ability to manage our growth; our dependence on the sales of a
limited number of products for a substantial portion of our total
revenues; the risk of product liability and other claims against us
by consumers and other third parties; risks related to changes in
the regulatory environment, including United States federal and
state laws related to healthcare fraud abuse and health information
privacy and security and changes in such laws; changes to FDA
product approval requirements; risks related to federal regulation
of arrangements between manufacturers of branded and generic
products; the impact of healthcare reform and changes in coverage
and reimbursement levels by governmental authorities and other
third-party payers; the continuing trend of consolidation of
certain customer groups; our reliance on certain licenses to
proprietary technologies from time to time; our dependence on third
party suppliers and distributors for raw materials for our products
and certain finished goods; our dependence on third party
agreements for a portion of our product offerings; our ability to
make acquisitions of or investments in complementary businesses and
products on advantageous terms; legal, regulatory and legislative
efforts by our brand competitors to deter competition from our
generic alternatives; the significant amount of resources we expend
on research and development; our substantial amount of indebtedness
and our ability to generate sufficient cash to service our
indebtedness in the future, and the impact of interest rate
fluctuations on such indebtedness; the high concentration of
ownership of our Class A Common Stock and the fact that we are
controlled by a group of stockholders. A further list and
descriptions of these risks, uncertainties and other factors can be
found in the Company’s most recently filed Annual Report on Form
10-K for the fiscal year ended December 31, 2018, as supplemented
by any subsequently filed Quarterly Reports on Form 10-Q. Copies of
these filings are available online at www.sec.gov, www.amneal.com
or on request from the Company.
Forward-looking statements included herein speak only as of the
date hereof and we undertake no obligation to revise or update such
statements to reflect the occurrence of events or circumstances
after the date hereof.
Trademarks referenced herein are the property of their
respective owner.
Amneal Pharmaceuticals, Inc.
Consolidated Statements of
Operations
(Unaudited; In thousands, except per
share amounts)
Three Months EndedMarch
31,
2019 2018 Net revenue $ 446,120
$ 275,189 Cost of goods sold 309,743 130,594 Cost of goods sold
impairment charges 53,297 —
Gross profit
83,080 144,595 Selling, general and administrative
84,436 25,121 Research and development 53,858 44,209 In-process
research and development impairment charges 22,787 — Acquisition,
transaction-related and integration expenses 6,032 7,135
Restructuring and other charges 6,161 — Intellectual property legal
development expenses 4,166 4,576
Operating (loss)
income (94,360 ) 63,554 Other (expense) income: Interest
expense, net (43,281 ) (21,051 ) Foreign exchange (loss) gain, net
(5,464 ) 8,565 Gain on sale of international business 8,818 — Other
income, net 1,107 948
Total other expense, net
(38,820 ) (11,538 ) (Loss) income before income taxes (133,180 )
52,016 (Benefit from) provision for income taxes (8,428 ) 364
Net (loss) income (124,752 ) 51,652 Less: Net income
attributable to Amneal Pharmaceuticals LLC pre-Combination —
(51,535 ) Less: Net loss (income) attributable to non-controlling
interests 76,871 (117 )
Net loss attributable to Amneal
Pharmaceuticals, Inc. $ (47,881 ) $ —
Net loss
per share attributable to Amneal Pharmaceuticals, Inc.'s common
stockholders: Class A and Class B-1 basic and diluted $ (0.37 )
Weighted-average common shares outstanding: Class A and
Class B-1 basic and diluted 127,687
Amneal Pharmaceuticals, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited; In thousands)
March 31, 2019 December 31, 2018 Assets
Current assets: Cash and cash equivalents $ 63,946 $ 213,394
Restricted cash 2,797 5,385 Trade accounts receivable, net 640,212
481,495 Inventories 448,294 457,219 Prepaid expenses and other
current assets 111,563 128,321 Related party receivables 1,156
830 Total current assets 1,267,968 1,286,644 Property, plant
and equipment, net 514,414 544,146 Goodwill 421,640 426,226
Intangible assets, net 1,591,158 1,654,969 Deferred tax asset, net
382,941 373,159 Operating lease right-of-use assets 63,238 —
Operating lease right-of-use assets - related party 17,565 —
Financing lease right-of-use assets - related party 63,240 — Other
assets 62,422 67,592 Total assets $ 4,384,586 $
4,352,736
Liabilities and Stockholders' Equity
Current liabilities: Accounts payable and accrued expenses $
558,750 $ 514,440 Current portion of long-term debt, net 21,445
21,449 Current portion of operating lease liabilities 13,173 —
Current portion of operating and financing lease liabilities -
related party 3,234 — Related party payables 2,928 17,695 Current
portion of financing obligation - related party — 266 Total
current liabilities 599,530 553,850 Long-term debt, net 2,625,152
2,630,598 Deferred income taxes — 1,178 Liabilities under tax
receivable agreement 193,499 192,884 Operating lease liabilities
51,200 — Operating lease liabilities - related party 15,445 —
Financing lease liabilities - related party 62,256 — Financing
obligation - related party — 39,083 Other long-term liabilities
37,723 38,780 Total long-term liabilities 2,985,275
2,902,523 Total stockholders' equity 799,781 896,363 Total
liabilities and stockholders' equity $ 4,384,586 $ 4,352,736
Amneal Pharmaceuticals, Inc.
Consolidated Statements of Cash
Flows
(Unaudited; In thousands)
Three Months Ended March 31, 2019
2018 Cash flows from operating activities: Net
(loss) income $ (124,752 ) $ 51,652 Adjustments to reconcile net
(loss) income to net cash (used in) provided by operating
activities: Depreciation and amortization 48,868 14,751
Amortization of Levothyroxine Transition Agreement 36,393 —
Unrealized foreign currency loss (gain) 6,490 (8,327 ) Amortization
of debt issuance costs 1,601 1,170 Gain on sale of international
business (8,818 ) — Intangible asset impairment charges 76,084 —
Deferred tax benefit (9,884 ) (512 ) Stock-based compensation
expense 4,347 — Inventory provision 15,650 2,845 Other operating
charges and credits, net 1,109 (3,431 ) Changes in assets and
liabilities: Trade accounts receivable, net (165,012 ) 4,981
Inventories (14,180 ) (47,589 ) Prepaid expenses, other current
assets and other assets 22,657 1,491 Related party receivables (314
) 5,215 Accounts payable, accrued expenses and other liabilities
695 15,325 Related party payables 656 (10,542 ) Net cash
(used in) provided by operating activities (108,410) 27,029
Cash
flows from investing activities: Purchases of property, plant
and equipment (17,988 ) (19,499 ) Cash sold with international
business (3,478 ) — Net cash used in investing activities
(21,466) (19,499)
Cash flows from financing activities:
Payments of principal on debt and capital leases (6,750 ) (3,543 )
Payments of principal on financing lease - related party (619 ) —
Payments of financing obligation - related party — (63 ) Proceeds
from exercise of stock options 1,010 — Capital contribution from
non-controlling interest — 360 Acquisition of non-controlling
interest (2,011 ) — Tax distribution to non-controlling interest
(13,494 ) — Distributions to members — (30,000 ) Net cash
used in financing activities (21,864 ) (33,246 ) Effect of foreign
exchange rate on cash (296 ) 411 Net decrease in cash, cash
equivalents, and restricted cash (152,036 ) (25,305 ) Cash, cash
equivalents, and restricted cash - beginning of period 218,779
77,922 Cash, cash equivalents, and restricted cash -
end of period $ 66,743 $ 52,617 Cash and cash
equivalents - end of period $ 63,946 $ 48,224 Restricted cash - end
of period 2,797 4,393 Cash, cash equivalents, and
restricted cash - end of period $ 66,743 $ 52,617
Amneal Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Combined
Results of Operations
(Unaudited; In thousands)
Three months ended March 31, 2019 Three months
ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Net revenue: Generics $
382,477 $ — $ 382,477 $ 275,189 $ 81,242 $ 356,431 Specialty 63,643
— 63,643 —
68,699
68,699 Total net revenue
446,120
— 446,120 275,189 149,941 425,130 Cost of goods sold 309,743 —
309,743 130,594 113,157 243,751 Cost of goods sold impairment
charges 53,297 — 53,297
— — —
Gross
profit 83,080 —
83,080 144,595 36,784
181,379 Selling, general and administrative 84,436 — 84,436
25,121 43,966 69,087 Research and development 53,858 — 53,858
44,209 12,296 56,505
In-process research and
developmentimpairment charges
22,787 — 22,787 — — —
Acquisition, transaction-related
andintegration expenses
6,032 — 6,032 7,135 6,544 13,679 Restructuring and other charges
6,161 — 6,161 — 4,900 4,900 Intellectual property legal development
expenses 4,166 — 4,166 4,576 23 4,599 Litigation, settlements and
related charges — — —
— 90,099 90,099
Operating (loss) income (94,360 ) —
(94,360 ) 63,554 (121,044 )
(57,490) Other (expense) income: Interest expense,
net (43,281 ) — (43,281 ) (21,051 ) (13,692 ) (34,743) Foreign
exchange (loss) gain, net (5,464 ) — (5,464 ) 8,565 921 9,486 Gain
on sale of international business 8,818 — 8,818 — — — Other income
(expense), net 1,107 —
1,107 948 (624 ) 324
Total other expense, net (38,820 ) —
(38,820 ) (11,538 ) (13,395 )
(24,933) (Loss) income before income taxes (133,180 ) —
(133,180 ) 52,016 (134,439 ) (82,423) (Benefit from) provision for
income taxes (8,428 ) — (8,428)
364 (7,290 ) (6,926)
Net (loss) income (124,752 ) — (124,752) 51,652 (127,149 )
(75,497)
Less: Net income attributable toAmneal
Pharmaceuticals LLC pre-Combination
— — — (51,535)
Less: Net loss (income) attributable
tonon-controlling interests
76,871 — 76,871
(117)
Net loss attributable to
AmnealPharmaceuticals, Inc.
$ (47,881 ) $ — $ (47,881 ) $ —
Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited; In thousands)
Reconciliations of Cost of Goods Sold
to Combined Adjusted Cost of Goods Sold
Generics Three months ended March 31, 2019
Three months ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Cost of goods sold $ 278,878 $
— $ 278,878 $ 130,594 $ 93,137 $ 223,731
Cost of goods sold
impairment charges 53,297 — 53,297 — — — Adjusted to deduct:
Amortization 10,751 — 10,751 1,760 9,889 11,649 Inventory related
charges(6) 334 — 334 — 6,889 6,889 Acquisition and site closure
expenses(7) 9,511 — 9,511 — — — Asset impairment charges(8) 53,297
— 53,297 — 53 53 Stock-based compensation expense 596 — 596 — — —
Amortization of upfront payment(10) 36,393 — 36,393 — — — Other
1,092 — 1,092 —
— —
Adjusted cost of
goods sold (Non-GAAP) $ 220,201 $ —
$ 220,201 $ 128,834 $
76,306 $ 205,140
Specialty
Three months ended March 31, 2019
Three months ended March 31, 2018
Add: (Non-GAAP)
Add: (Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Cost of goods sold $ 30,865 $
— $ 30,865 $ — $ 20,020 $ 20,020 Adjusted to deduct: Amortization
20,211 — 20,211 —
4,584 4,584
Adjusted
cost of goods sold (Non-GAAP) $ 10,654 $ —
$ 10,654 $ — $
15,436 $ 15,436
Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited; In thousands)
Reconciliations of Operating (Loss)
Income to Combined Adjusted Operating Income
Generics Three months ended March 31, 2019
Three months ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Operating (loss) income $
(54,583 ) $ — $ (54,583 ) $ 84,607 $ (113,710 ) $ (29,103 )
Adjusted to add (deduct): Acquisition and site closure expenses(7)
18,785 — 18,785 — — — Amortization 10,752 — 10,752 1,760 9,889
11,649 Inventory related charges(6) 334 — 334 — 6,889 6,889
Stock-based compensation expense 1,498 — 1,498 — 982 982 Asset
impairment charges(8) 76,152 — 76,152 — 53 53 Restructuring and
other charges(9) 2,081 — 2,081 — — — Litigation, settlements and
related charges(11) — — — — 89,159 89,159 Amortization of upfront
payment (10) 36,393 — 36,393 — — — R&D milestone payment 4,315
— 4,315 1,276 — 1,276 Other 1,092 —
1,092 (180 ) 1,325
1,145
Adjusted operating income (Non-GAAP) $
96,819 $ — $ 96,819
$ 87,463 $ (5,413 ) $
82,050
Specialty Three
months ended March 31, 2019 Three months ended
March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Operating income $ 4,637 $ — $
4,637 $ — $ 24,847 $ 24,847 Adjusted to add: Amortization 20,212 —
20,212 — 4,584 4,584 Acquisition and site closure expenses(7) 3,555
— 3,555 — — — Stock-based compensation expense 144 — 144 — 1,124
1,124 Restructuring and other charges(9) 178 —
178 — —
—
Adjusted operating income (Non-GAAP) $
28,726 $ — $ 28,726
$ — $ 31,495 $
31,495
Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited; In thousands, except per
share amounts)
Reconciliation of Net (Loss) Income to
Combined Adjusted Net Income and Calculation of Adjusted Diluted
EPS
Three months ended March 31, 2019 Three months
ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Net (loss) income $ (124,752 )
$ — $ (124,752 ) $ 51,652 $ (127,149 ) $ (75,497 ) Adjusted to add
(deduct): Non-cash interest 1,601 — 1,601 1,170 6,864 8,034 GAAP
Income tax (benefit) expense (8,428 ) — (8,428 ) 364 (7,290 )
(6,926 ) Amortization 30,963 — 30,963 1,760 14,473 16,233
Stock-based compensation expense 4,347 — 4,347 — 4,816 4,816
Acquisition and site closure expenses(7) 28,202 — 28,202 7,135
6,544 13,679 Restructuring and other charges(9) 6,161 — 6,161 —
4,900 4,900 Inventory related charges(6) 334 — 334 — 6,889 6,889
Litigation, settlements and related charges(11) — — — — 90,099
90,099 Asset impairment charges(8) 76,600 — 76,600 — 53 53
Amortization of upfront payment(10) 36,393 — 36,393 — — — Foreign
exchange loss (gain) 5,464 — 5,464 (8,565 ) (921 ) (9,486 ) Gain on
sale of international business(12) (8,818 ) — (8,818 ) — — —
R&D milestone payments 4,315 — 4,315 1,276 — 1,276 Other 1,092
— 1,092 (2,045 ) 653 (1,392 ) Income tax (11,230 ) — (11,230 )
(11,077 ) 245 (10,832 )
Net income attributable to NCI
notassociated with our Class B shares
(79 ) — (79 ) —
— —
Adjusted net income
(Non-GAAP) $ 42,165 $ —
$ 42,165 $ 41,670 $ 176
$ 41,846
Adjusted diluted EPS
(Non-GAAP)(13)
$ 0.14
(13) Under the if-converted method, utilizes weighted average
diluted shares outstanding of 298,957, which consists of Class A,
Class B & Class B-1 shares.
Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited, In thousands)
Reconciliation of Net (Loss) Income to
EBITDA and Combined Adjusted EBITDA
Three months ended March 31, 2019 Three months
ended March 31, 2018 Add:
(Non-GAAP) Add:
(Non-GAAP) Actual
Impax/Gemini
Combined Actual
Impax/Gemini
Combined Net (loss) income $ (124,752 )
$ — $ (124,752 ) $ 51,652 $ (127,149 ) $ (75,497 ) Adjusted to add
(deduct): Interest expense, net 43,281 — 43,281 21,051 13,692
34,743 Income tax (benefit) expense (8,428 ) — (8,428 ) 364 (7,290
) (6,926 ) Depreciation and amortization 48,868
— 48,868 14,751
17,975 32,726
EBITDA
(Non-GAAP) $ (41,031 ) $ — $
(41,031 ) $ 87,818 $ (102,772 )
$ (14,954 ) Adjusted to add (deduct): Stock-based
compensation expense $ 4,347 $ — $ 4,347 $ — $ 4,816 $ 4,816
Acquisition and site closure expenses(7) 28,202 — 28,202 7,135
6,544 13,679 Restructuring and other charges(9) 6,161 — 6,161 —
4,900 4,900 Inventory related charges(6) 334 — 334 — 6,889 6,889
Litigation, settlements and related charges(11) — — — — 90,099
90,099 Asset impairment charges(8) 76,600 — 76,600 — 53 53
Amortization of upfront payment(10) 36,393 — 36,393 — — — Foreign
exchange loss (gain) 5,464 — 5,464 (8,565 ) (921 ) (9,486 ) Gain on
sale of international business(12) (8,818 ) — (8,818 ) — — —
R&D milestone payments 4,315 — 4,315 1,276 — 1,276 Other —
— — (2,045 )
653 (1,392 )
Adjusted EBITDA
(Non-GAAP) $ 111,967 $ —
$ 111,967 $ 85,619 $ 10,261
$ 95,880
(6) For the three months ended March 31, 2019, inventory related
charges primarily represents the amortization of the Impax
inventory step-up to fair value in purchase accounting. For the
three months ended March 31, 2018, inventory related charges
primarily represents a reserve for an unfavorable supply
arrangement.
(7) Acquisition and site closure expenses for the three months
ended March 31, 2019 includes costs related to (i) plant closure
and redundant employee costs and (ii) third party costs associated
with the combination of Impax and related integration including
legal, investment banking, accounting and information technology.
For the three months ended March 31, 2018, acquisition and site
closure expenses also includes costs associated with the Impax sale
of its Middlesex, NJ and Taiwan facilities.
(8) Asset impairment charges for the three months ended March
31, 2019 are primarily associated with the write-off of in process
research and development product rights and intangible asset
impairment charges primarily related to four products acquired in
the Impax combination.
(9) Restructuring and other charges includes employee separation
costs associated with the consolidation of sites, as well as the
write-off of property, plant, and equipment at those sites.
(10) Amortization of upfront payment represents the amortization
of the upfront payment made to Lannett in connection with our
Transition Agreement with Levothyroxine.
(11) Litigation, settlements and related charges represents an
Impax litigation settlement charge for the three months ended March
31, 2018 related to a settlement of claims with the plaintiffs in
the class action antitrust suits related to Solodyn®.
(12) Gain on the sale of international business represents the
gain from the sale of our Creo Pharma Holding Limited subsidiary,
which comprised the Company's entire operations in the United
Kingdom.
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005248/en/
Mark Donohue(908) 409-6718
Amneal Pharmaceuticals (NYSE:AMRX)
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