BAUDETTE, Minn., May 4, 2017 /PRNewswire/ --
For the first quarter 2017:
- Net revenues of $36.6 million,
an increase of 78% as compared to the same period in 2016
- GAAP net income of $1.2
million and diluted GAAP earnings per share of $0.10
- Adjusted non-GAAP EBITDA of $14.7
million
- Adjusted non-GAAP diluted earnings per share of $0.74
ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today
reported its financial results for the three months ended
March 31, 2017, and reaffirmed its
2017 financial guidance. The Company will host its earnings
conference call this morning, May 4,
2017, at 10:30 AM ET.
Investors and other interested parties can join the call by dialing
(866) 776-8875. The conference ID is 93296077.
Financial
Summary
|
|
(in thousands,
except per share data)
|
|
Q1
2017
|
|
Q1
2016
|
|
Net
revenues
|
|
$ 36,628
|
|
$20,555
|
|
Net
income
|
|
$
1,152
|
|
$
1,346
|
|
GAAP earnings per
diluted share
|
|
$
0.10
|
|
$
0.12
|
|
Adjusted non-GAAP
EBITDA(a)
|
|
$ 14,729
|
|
$11,380
|
|
Adjusted
non-GAAP diluted earnings per
share(b)
|
|
$
0.74
|
|
$
0.53
|
|
|
|
(a)
|
See Table 2 for US
GAAP reconciliation.
|
(b)
|
See Table 3 for US
GAAP reconciliation.
|
Arthur S. Przybyl, President and
CEO, stated,
"ANI had a strong quarter, with
revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted
earnings per share increasing 78%, 29%, and 40%, respectively, as
compared to the prior year. In the first quarter, we achieved our
internal projections and, as a result, we are reaffirming our
guidance for 2017. Results for 2017 will include the impact of
recent contract wins that have increased our market share of EEMT
to approximately 65%, the full effect of which will begin in the
second quarter. Results for 2017 will also include the impacts of
the launch of the InnoPran XL® and Inderal® XL products, the launch
of Inderal® LA in the ANI label, and additional targeted product
launches. These factors will have a positive effect on our revenues
and adjusted non-GAAP EBITDA for the remainder of the year."
ANI Reaffirms Guidance for the Full Year 2017
ANI's estimates are based on projected results for the twelve
months ending December 31, 2017 and
reflect management's current beliefs about product pricing,
prescription trends, inventory levels, cost of sales, operating
costs, taxes, and the anticipated timing of future product launches
and events.
- Net revenues for 2017 to be between $181 million and
$190 million.
- Cost of sales as a percent of revenues, excluding impact of
inventory step-up, to be between 42% and 44%.
- Sales, general, and administrative costs to be between
$30.2 million and $30.9 million.
- Research and development costs to be between $6.5 million and $6.8 million.
- Adjusted non-GAAP EBITDA to be between $73.1 million and $77.2 million.
- Adjusted non-GAAP diluted earnings per share to be between
$3.58 and $3.94.
Corticotropin Re-commercialization Update
In the first quarter 2017, ANI's active pharmaceutical
ingredient ("API") manufacturer successfully manufactured a
development lot of Corticotropin API, replicating the yield and
process from when the API was last manufactured. In the second
quarter, ANI has initiated the scale-up of the API manufacturing
process and process characterization, which is the next step prior
to commercial scale API manufacturing. ANI has identified potential
finished dosage form contract manufacturers and plans to select one
and initiate Corticotropin finished dosage form manufacturing in
the second half of 2017. ANI has continued to make progress
developing analytical methods to analyze the components of the
purified Corticotropin API powder. These analytical methods
are being used to generate results that are, in turn, compared to
results from historical batches of API. ANI has developed a
comprehensive regulatory filing plan for the Corticotropin Gel
product and intends to meet and present the plan to the FDA in
the second half of 2017.
First Quarter
Results
|
|
Net
Revenues
(in
thousands)
|
|
Three Months
Ended
March 31,
|
|
|
|
|
|
|
2017
|
|
2016
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
26,572
|
|
$
|
13,252
|
|
$
|
13,320
|
|
101%
|
Branded
pharmaceutical products
|
|
|
8,039
|
|
|
5,596
|
|
|
2,443
|
|
44%
|
Contract
manufacturing
|
|
|
1,793
|
|
|
1,384
|
|
|
409
|
|
30%
|
Contract services and
other income
|
|
|
224
|
|
|
323
|
|
|
(99)
|
|
(31)%
|
Total net
revenues
|
|
$
|
36,628
|
|
$
|
20,555
|
|
$
|
16,073
|
|
78%
|
For the three months ended March 31,
2017, ANI reported net revenues of $36.6 million, an increase of 78% from
$20.6 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 101%,
to $26.6 million from $13.3 million in the prior period, primarily due
to sales of the generic products launched during 2016.
- Revenues from sales of branded pharmaceuticals increased 44%,
to $8.0 million from $5.6 million in the prior period, primarily due
to sales of Inderal® LA, which was launched in Q2 2016, and sales
of Inderal® XL and InnoPran XL®, which were launched in late
February 2017.
- Contract manufacturing revenue increased by 30% to $1.8 million from $1.4
million in the prior year period, primarily as a result of
the timing and volume of customer orders.
- Contract services and other income decreased by 31%, to
$0.2 million from $0.3 million, primarily because sales of
Fenofibrate in the ANI label have replaced the royalties previously
received on the product.
Operating expenses increased to $32.0
million for the three months ended March 31, 2017, from $14.9
million in the prior year period. The increase was primarily
due to a $13.0 million increase in
cost of sales as compared with the prior period, as a result of a
higher sales of products sold with profit-sharing arrangements,
increased volume, and $1.5 million of
cost of sales related to the net inventory step-up on Inderal® LA,
Inderal® XL, and InnoPran XL® inventory. In addition, depreciation
and amortization increased by $2.1
million as compared with the prior period, driven by
amortization of a higher intangible asset base.
Excluding the $1.5 million of net
inventory step-up costs related to sales of Inderal® LA, Inderal®
XL, and InnoPran XL®, cost of sales increased as a percentage of
net revenues to 41% from 17%, primarily as a result of increased
sales of products with profit-sharing arrangements.
Net income was $1.2 million for
the three months ended March 31,
2017, as compared to net income of $1.3 million in the prior year period. The
effective tax rate for the three months ended March 31, 2017 was 31%.
Diluted earnings per share for the three months ended
March 31, 2017 was $0.10, based on 11,653 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.12 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $0.74, as compared to adjusted non-GAAP diluted
earnings per share of $0.53 in the
prior year period. For a reconciliation of adjusted non-GAAP
diluted earnings per share to the most directly comparable GAAP
financial measure, please see Table 3.
Selected Balance
Sheet Data
|
|
(in
thousands)
|
|
|
March 31,
2017
|
December 31,
2016
|
Cash
|
$
10,826
|
$
27,365
|
Accounts receivable,
net
|
$
46,697
|
$
45,895
|
Inventory,
net
|
$
45,893
|
$
26,183
|
Current
assets
|
$
106,981
|
$
103,007
|
Current
liabilities
|
$
32,425
|
$
31,948
|
ANI generated $6.5 million of
positive cash flows from operations in the three months ended
March 31, 2017. In February 2017, ANI purchased from Cranford
Pharmaceuticals, LLC a distribution license, trademark and certain
finished goods inventory for Inderal® XL for $20.2 million in cash, using cash on hand. In
February 2017, ANI purchased from
Holmdel Pharmaceuticals, LP the NDA, trademark, and certain
finished goods inventory for InnoPran XL®, including a license to
an Orange Book listed patent, for $30.6
million in cash. ANI made the $30.6
million cash payment using $30.0
million of funds from its Line of Credit and $0.6 million of cash on hand.
ANI Product Development Pipeline
ANI's pipeline consists of 76 products, addressing a total
annual market size of $3.7 billion,
based on data from IMS Health. Of these 76 products, 53 were
acquired and of these acquired products, ANI expects that 46 can be
commercialized based on either CBE-30s or prior approval
supplements filed with the FDA.
Non-GAAP Financial Measures
The Company's fiscal 2017 guidance for adjusted non-GAAP EBITDA
and adjusted non-GAAP diluted earnings per share is not reconciled
to the most comparable GAAP measure. This is due to the inherent
difficulty of forecasting the timing or amount of items that would
be included in a reconciliation to the most directly comparable
forward-looking GAAP financial measures. Because a reconciliation
is not available without unreasonable effort, it is not included in
this release.
Adjusted non-GAAP EBITDA
ANI's management considers adjusted non-GAAP EBITDA to be an
important financial indicator of ANI's operating performance,
providing investors and analysts with a useful measure of operating
results unaffected by non-cash stock-based compensation and
differences in capital structures, tax structures, capital
investment cycles, ages of related assets, and compensation
structures among otherwise comparable companies. Management uses
adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net income/(loss),
excluding tax expense, interest expense, depreciation,
amortization, the excess of fair value over cost of acquired
inventory, stock-based compensation expense, costs related to major
transactions not consummated, and other income / expense. Adjusted
non-GAAP EBITDA should be considered in addition to, but not in
lieu of, net income or loss reported under GAAP. A reconciliation
of adjusted non-GAAP EBITDA to the most directly comparable GAAP
financial measure is provided in Table 2.
Adjusted non-GAAP Net Income
ANI's management considers adjusted non-GAAP net income to be an
important financial indicator of ANI's operating performance,
providing investors and analysts with a useful measure of operating
results unaffected by purchase accounting adjustments, non-cash
stock-based compensation, non-cash interest expense, depreciation
and amortization, and non-cash impairment charges. Management uses
adjusted non-GAAP net income when analyzing Company
performance.
Adjusted non-GAAP net income is defined as net income/(loss),
plus the excess of fair value over cost of acquired inventory,
stock-based compensation expense, costs related to major
transactions not consummated, non-cash interest expense,
depreciation and amortization expense, and non-cash impairment
charges, less the tax impact of these adjustments calculated using
an estimated statutory tax rate. Management will continually
analyze this metric and may include additional adjustments in the
calculation in order to provide further understanding of ANI's
results. Adjusted non-GAAP net income should be considered in
addition to, but not in lieu of, net income reported under GAAP. A
reconciliation of adjusted non-GAAP net income to the most directly
comparable GAAP financial measure is provided in Table 3.
Adjusted non-GAAP Diluted Earnings per Share
ANI's management considers adjusted non-GAAP diluted earnings
per share to be an important financial indicator of ANI's operating
performance, providing investors and analysts with a useful measure
of operating results unaffected by purchase accounting adjustments,
non-cash stock-based compensation, non-cash interest expense,
depreciation and amortization, and non-cash impairment charges.
Management uses adjusted non-GAAP diluted earnings per share when
analyzing Company performance.
Adjusted non-GAAP diluted earnings per share is defined as
adjusted non-GAAP net income, as defined above, divided by the
diluted weighted average shares outstanding during the period.
Management will continually analyze this metric and may include
additional adjustments in the calculation in order to provide
further understanding of ANI's results. Adjusted non-GAAP diluted
earnings per share should be considered in addition to, but not in
lieu of, diluted earnings or loss per share reported under GAAP. A
reconciliation of adjusted non-GAAP diluted earnings per share to
the most directly comparable GAAP financial measure is provided in
Table 3.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing high quality branded and generic
prescription pharmaceuticals. The Company's targeted areas of
product development currently include controlled substances,
oncolytics (anti-cancers), hormones and steroids, and complex
formulations involving extended release and combination products.
For more information, please visit the Company's website
www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with
information that is not historical, these are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements about price increases, the Company's future
operations, products financial position, operating results and
prospects, the Company's pipeline or potential markets therefor,
and other statements that are not historical in nature,
particularly those that utilize terminology such as "anticipates,"
"will," "expects," "plans," "potential," "future," "believes,"
"intends," "continue," other words of similar meaning, derivations
of such words and the use of future dates.
Uncertainties and risks may cause the Company's actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risk that the Company may face with
respect to importing raw materials; increased competition;
acquisitions; contract manufacturing arrangements; delays or
failure in obtaining product approvals from the U.S. Food and Drug
Administration; general business and economic conditions; market
trends; products development; regulatory and other approvals; and
marketing.
More detailed information on these and additional factors that
could affect the Company's actual results are described in the
Company's filings with the Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K and quarterly
reports on Form 10-Q, as well as its proxy statement. All
forward-looking statements in this news release speak only as of
the date of this news release and are based on the Company's
current beliefs, assumptions, and expectations. The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 1: US GAAP
Income Statement
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$36,628
|
|
$20,555
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
Cost of
sales (excl. depreciation and amortization)
|
|
16,386
|
|
3,410
|
|
Research and
development
|
|
1,618
|
|
966
|
|
Selling,
general, and administrative
|
|
7,293
|
|
5,904
|
|
Depreciation
and amortization
|
|
6,706
|
|
4,609
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
|
32,003
|
|
14,889
|
|
|
|
|
|
|
|
Operating Income
|
|
4,625
|
|
5,666
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
Interest
expense, net
|
|
(2,932)
|
|
(2,782)
|
|
Other
(expense)/income, net
|
|
(18)
|
|
2
|
|
|
|
|
|
|
|
Income Before
Provision for Income Taxes
|
|
1,675
|
|
2,886
|
|
|
|
|
|
|
|
Provision for Income
Taxes
|
|
(523)
|
|
(1,540)
|
|
|
|
|
|
|
|
Net Income
|
|
$
1,152
|
|
$
1,346
|
|
|
|
|
|
|
|
Earnings Per
Share
|
|
|
|
|
|
Basic Earnings Per
Share
|
|
$
0.10
|
|
$
0.12
|
|
Diluted Earnings Per
Share
|
|
$
0.10
|
|
$
0.12
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
11,527
|
|
11,395
|
|
Diluted
Weighted-Average Shares Outstanding
|
|
11,653
|
|
11,489
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 2: Adjusted
non-GAAP EBITDA Calculation and US GAAP to Non-GAAP
Reconciliation
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
Net
Income
|
|
$
1,152
|
|
$
1,346
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
Interest
expense, net
|
|
2,932
|
|
2,782
|
|
Other
income/(expense), net
|
|
18
|
|
(2)
|
|
Provision for income taxes
|
|
523
|
|
1,540
|
|
Depreciation and amortization
|
|
6,706
|
|
4,609
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
Stock-based compensation
|
|
1,386
|
|
1,105
|
|
Excess
of fair value over cost of acquired inventory
|
|
1,535
|
|
-
|
|
Expenses
related to transaction not consummated
|
|
477
|
|
-
|
|
Adjusted non-GAAP EBITDA
|
|
$14,729
|
|
$11,380
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 3: Adjusted
non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per
Share Reconciliation
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
Net
Income
|
|
$1,152
|
|
$1,346
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
Non-cash interest expense
|
|
1,792
|
|
1,725
|
|
Depreciation and amortization expense
|
|
6,706
|
|
4,609
|
|
Stock-based compensation
|
|
1,386
|
|
1,105
|
|
Excess of fair value over cost of acquired inventory
|
|
1,535
|
|
-
|
|
Expenses related to transaction not consummated
|
|
477
|
|
-
|
|
Less
|
|
|
|
|
|
Tax
impact of adjustments
|
|
(4,402)
|
|
(2,752)
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
|
$8,646
|
|
$6,033
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
|
Shares
Outstanding
|
|
11,653
|
|
11,489
|
|
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
|
Diluted Earnings per Share
|
|
$
0.74
|
|
$
0.53
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-first-quarter-results-and-year-to-date-2017-highlights-and-reaffirms-guidance-300450776.html
SOURCE ANI Pharmaceuticals, Inc.