BAUDETTE, Minn., Aug. 4, 2016 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported
financial results for the three and six months ended June 30, 2016, and increased its financial
guidance for 2016. The Company will host its earnings conference
call this morning, August 4, 2016, at
10:30 AM ET. Investors and other
interested parties can join the call by dialing (866) 776-8875. The
conference ID is 47510730.
Financial
Summary
|
|
(in thousands,
except per share data)
|
|
Q2
2016
|
|
Q2
2015
|
|
YTD
2016
|
|
YTD
2015
|
Net
revenues
|
|
$31,337
|
|
$19,516
|
|
$51,892
|
|
$38,315
|
Net
income
|
|
$
1,125
|
|
$
3,571
|
|
$
2,471
|
|
$
7,940
|
GAAP earnings per
diluted share
|
|
$
0.10
|
|
$
0.31
|
|
$
0.21
|
|
$
0.68
|
Adjusted non-GAAP
EBITDA(a)
|
|
$15,445
|
|
$10,858
|
|
$26,825
|
|
$22,320
|
Adjusted non-GAAP
net income per diluted share(b)
|
|
$
1.11
|
|
$
0.68
|
|
$
1.87
|
|
$
1.40
|
|
|
|
|
|
|
|
|
|
(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 record second quarter, with revenues, adjusted
non-GAAP EBITDA, and adjusted non-GAAP net income per diluted share
increasing 61%, 42%, and 63%, respectively, as a result of seven
product launches.
In July, we received FDA approval for and immediately launched
our generic anti-cancer product, Nilutamide. We look forward to
launching our anti-infective product in the third quarter and
continue to guide to approximately $20
million of combined annualized EBITDA from these two
important products."
ANI Increases Full Year 2016 Guidance
ANI's estimates are based on projected results for the twelve
months ending December 31, 2016 and
reflect management's current beliefs about product pricing,
prescription trends, inventory levels, cost of sales, operating
costs, and the anticipated timing of future product launches and
events.
- Net revenues for 2016 to be between $119 million and
$134 million.
- Reported (US GAAP) diluted EPS to be between $0.60 and $0.85, assuming 11,514 thousand
weighted average shares outstanding.
- Adjusted non-GAAP EBITDA to be between $58 million and $66 million.
- Adjusted non-GAAP net income per diluted share to be between
$4.00 and $4.25.
Second Quarter
Results
|
|
Net
Revenues
(in
thousands)
|
|
Three Months
Ended
June 30,
|
|
|
|
|
2016
|
|
2015
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
22,463
|
|
$
|
13,764
|
|
$
|
8,669
|
|
63%
|
Branded
pharmaceutical products
|
|
|
7,488
|
|
|
2,136
|
|
|
5,352
|
|
251%
|
Contract
manufacturing
|
|
|
1,166
|
|
|
1,091
|
|
|
75
|
|
7%
|
Contract services and
other income
|
|
|
220
|
|
|
2,525
|
|
|
(2,305)
|
|
(91)%
|
Total net
revenues
|
|
$
|
31,337
|
|
$
|
19,516
|
|
$
|
11,821
|
|
61%
|
For the three months ended June 30,
2016, ANI reported net revenues of $31.3 million, an increase of 61%
from $19.5 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 63%,
to $22.5 million from $13.8 million in the prior period, primarily due
to sales of Propranolol ER and other products launched in Q2 2016,
as well as sales of Vancomycin, which was launched in the ANI label
in Q4 2015.
- Revenues from sales of branded pharmaceuticals increased 251%,
to $7.5 million from $2.1 million in the prior period, primarily due
to sales of InderalĀ® LA, which was launched in Q2 2016.
- Contract manufacturing revenue increased by 7% to $1.2 million from $1.1
million in the prior year period, primarily as a result of
the timing of customer orders.
- Contract services and other income decreased by 91%, to
$0.2 million from $2.5 million, primarily because sales of
Vancomycin in the ANI label have replaced the royalties received on
the product previously.
Operating expenses increased to $26.1
million for the three months ended June 30, 2016, from $11.1
million in the prior year period. The increase was primarily
due to an $8.7 million increase in
cost of sales as compared with the prior period, as a result of
increased volume, higher mix of sales of products with
profit-sharing arrangements, as well as $2.1
million of cost of sales related to the inventory step-up on
InderalĀ® LA and Propranolol ER inventory. In addition, depreciation
and amortization increased by $4.5
million as compared with the prior period driven by
amortization of a higher intangible asset base. Selling, general,
and administrative expenses for the period includes $1.3 million of principally non-cash expense,
representing the entire cost of ANI's CFO transition.
Excluding the $2.1 million of
costs related to the InderalĀ® LA inventory step-up, cost of sales
increased as a percentage of net revenues to 31% from 16%,
primarily as a result of increased sales of products with
profit-sharing arrangements.
Net income was $1.1 million for the three months
ended June 30, 2016, as compared to
net income of $3.6 million in the
prior year period. The effective tax rate for the three months
ended June 30, 2016 was 52%,
including a 66% rate for current taxes partially offset by a 14%
rate benefit for deferred taxes.
Diluted earnings per share for the three months ended
June 30, 2016 was $0.10, based on 11,541 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.31 in the prior year period.
Adjusted non-GAAP net income per diluted share was $1.11, as compared to adjusted non-GAAP net
income per diluted share of $0.68 in
the prior year period. For a reconciliation of adjusted non-GAAP
net income per diluted share to the most directly comparable GAAP
financial measure, please see Table 3.
Results for Six
Months Ended June 30, 2016
|
|
Net
Revenues
(in
thousands)
|
|
Six Months
Ended June
30,
|
|
|
|
|
2016
|
|
2015
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
35,715
|
|
$
|
26,021
|
|
$
|
9,694
|
|
37%
|
Branded
pharmaceutical products
|
|
|
13,084
|
|
|
6,408
|
|
|
6,676
|
|
104%
|
Contract
manufacturing
|
|
|
2,550
|
|
|
2,295
|
|
|
255
|
|
11%
|
Contract services and
other income
|
|
|
543
|
|
|
3,591
|
|
|
(3,048)
|
|
(85)%
|
Total net
revenues
|
|
$
|
51,892
|
|
$
|
38,315
|
|
$
|
13,577
|
|
35%
|
For the six months ended June 30,
2016, ANI reported net revenues of $51.9 million, an increase of 35%
from $38.3 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 37%,
to $35.7 million from $26.0 million in the prior period, primarily due
to sales of Propranolol ER and other products launched in Q2 2016,
as well as sales of Vancomycin, which was launched in the ANI label
in Q4 2015.
- Revenues from sales of branded pharmaceuticals more than
doubled to $13.1 million as compared
to $6.4 million in the prior period,
primarily due to sales of InderalĀ® LA, which was launched in Q2
2016.
- Contract manufacturing revenue increased by 11% to $2.6 million from $2.3
million in the prior year period, primarily as a result of
the timing of customer orders.
- Contract services and other income decreased by 85%, to
$0.5 million from $3.6 million, primarily because sales of
Vancomycin in the ANI label have replaced the royalties received on
the product previously, partially offset by royalty income on sales
of Fenofibrate, the authorized generic of LipofenĀ®. ANI received
royalties on sales of Fenofibrate during a brief transition period
prior to launching under the ANI label.
Operating expenses increased to $41.0
million for the six months ended June
30, 2016, from $20.3 million
in the prior year period. The increase was primarily due to a
$9.3 million increase in cost of
sales as compared with the prior period, as a result of increased
volumes, higher mix of sales of products with profit-sharing
arrangements, as well as $2.1 million
of cost of sales related to the inventory step-up on InderalĀ® LA
and Propranolol ER inventory. In addition, depreciation and
amortization increased by $7.8
million as compared with the prior period driven by
amortization of a higher intangible asset base. Selling, general,
and administrative expenses for the period includes $1.3 million of principally non-cash expense,
representing the entire cost of ANI's CFO transition.
Excluding the $2.1 million of
costs related to the InderalĀ® LA inventory step-up, cost of sales
increased as a percentage of net revenues to 25% from 15%,
primarily as a result of increased sales of products with
profit-sharing arrangements.
Net income was $2.5 million for the six months ended
June 30, 2016, as compared to net
income of $7.9 million in the prior
year period. The effective tax rate for the six months ended
June 30, 2016 was 53%, including a
61% rate for current taxes partially offset by an 8% rate benefit
for deferred taxes.
Diluted earnings per share for the six months ended June 30, 2016 was $0.21, based on 11,514 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.68 in the prior year period.
Adjusted non-GAAP net income per diluted share was $1.87, as compared to adjusted non-GAAP net
income per diluted share of $1.40 in
the prior year period. For a reconciliation of adjusted non-GAAP
net income per diluted share to the most directly comparable GAAP
financial measure, please see Table 3.
Year-to-Date Highlights Include:
- Record year-to-date net revenues of $51.9 million, an increase of 35% as compared to
the same period in 2015.
- Year-to-date net income of $2.5
million and year-to-date diluted earnings per share of
$0.21, each a decrease of 69% as
compared to the same period in 2015.
- Year-to-date adjusted non-GAAP EBITDA of $26.8 million, an increase of 20% as compared to
the same period in 2015.
- Year-to-date adjusted non-GAAP diluted earnings per share of
$1.87, an increase of 34% as compared
to the same period in 2015.
- Acquired NDAs for Corticotropin and Corticotropin-Zinc.
- Acquired exclusive rights to distribute an authorized generic
of LipofenĀ® and 1% and 2.5% hydrocortisone rectal cream.
- Acquired the NDA for InderalĀ® LA.
- Received ANDA approval for Oxycodone capsules and PAS approval
for Oxcarbazepine tablets.
- Received ANDA approval for and immediately launched Nilutamide
tablets.
- Entered into a distribution and supply agreement with Aspen
Global Incorporated to market and distribute Hydroxyprogesterone
Caproate Injection in the U.S.
Selected Balance
Sheet Data
|
|
(in
thousands)
|
|
|
June 30,
2016
|
December 31,
2015
|
Cash
|
$
15,014
|
$
154,684
|
Accounts receivable,
net
|
$
35,562
|
$
21,932
|
Inventory,
net
|
$
25,052
|
$
13,387
|
Current
assets
|
$
79,824
|
$
192,583
|
Current
liabilities
|
$
24,730
|
$
11,756
|
ANI generated $14.3 million of
positive cash flows from operations in the six months ended
June 30, 2016. In January 2016, ANI purchased from Merck the NDAs
for Corticotropin and Corticotropin-Zinc for $75.0 million and a percentage of future net
sales on products sold under the NDAs. Also in January 2016, ANI purchased from H2-Pharma, LLC
the exclusive U.S. distribution rights for two products, as well as
an early stage development project for a generic injectable drug
product, for $8.8 million in cash and
the assumption of an accrued royalty of $1.2
million. In April 2016, ANI
purchased from Cranford Pharmaceuticals, LLC the rights, title, and
interest in the NDA for InderalĀ® LA, as well as certain
documentation, trademark rights, and finished goods for
$60 million in cash and milestone
payments based on future gross profits from sales of products under
the NDA. ANI also transferred $5.0
million to an escrow account to secure the future milestone
payments. As a result of the net effect of these sources and uses
of cash, ANI had $15.0 million of
cash at June 30, 2016.
New Product
Introductions
|
|
Product
|
|
Total Annual
Market Size(c)
|
|
Estimated
Launch
|
|
FDA Approvals
Required
|
Nilutamide
|
|
$23M
|
|
Launched July
2016
|
|
Approved
|
Anti-Infective
|
|
$77M
|
|
Q3 2016
|
|
CBE-30
|
IDT
product
|
|
$11M
|
|
Q1 2017
|
|
CBE-30
|
Three additional C-II
products (TADs(d) 1/2/2017 and
2/15/2017)
|
|
$39M
|
|
Q1 2017
|
|
ANDAs
|
|
|
|
|
|
|
|
(c)
|
Per IMS
Health
|
(d)
|
FDA's Target Action
Date, per FDA communications
|
ANI Product Development Pipeline
ANI's pipeline consists of 79 products, addressing a total
annual market size of $3.9 billion,
based on data from IMS Health. Of these 79 products, 54 were
acquired and of these acquired products, ANI expects that 47 can be
commercialized based on either CBE-30s or prior approval
supplements filed with the FDA.
Non-GAAP Financial Measures
The Company's fiscal 2016 guidance for adjusted non-GAAP EBITDA
and adjusted non-GAAP net income per diluted 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 depreciation, amortization, the excess of fair value over
cost of acquired inventory, and stock-based compensation 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 non-cash stock-based compensation, non-cash
interest expense, depreciation amortization, and deferred tax
expenses and benefits. Management uses adjusted non-GAAP net income
when analyzing Company performance.
Adjusted non-GAAP net income is defined as net income/(loss),
plus tax expense, the excess of fair value over cost of acquired
inventory, stock-based compensation expense, non-cash interest
expense, depreciation and amortization expense, less the current
portion of the tax provision. 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 Net Income per Diluted Share
ANI's management considers adjusted non-GAAP net income per
diluted 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 non-cash
stock-based compensation, non-cash interest expense, depreciation,
amortization, and deferred tax expenses and benefits. Management
uses adjusted non-GAAP net income per diluted share when analyzing
Company performance.
Adjusted non-GAAP net income per diluted share is defined as
adjusted non-GAAP net income, as defined above, divided by the
diluted weighted average shares outstanding during the period.
Adjusted non-GAAP net income per diluted share should be considered
in addition to, but not in lieu of, earnings or loss per share
reported under GAAP. A reconciliation of adjusted non-GAAP net
income per diluted 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 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
June 30,
|
|
Six Months Ended
June 30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Net
Revenues
|
$31,337
|
|
$19,516
|
|
$51,892
|
|
$38,315
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
Cost of sales
(excl. depreciation and amortization)
|
11,795
|
|
3,141
|
|
15,205
|
|
5,892
|
Research and
development
|
764
|
|
995
|
|
1,730
|
|
1,398
|
Selling, general, and
administrative
|
7,628
|
|
5,551
|
|
13,532
|
|
10,302
|
Depreciation and
amortization
|
5,956
|
|
1,415
|
|
10,565
|
|
2,742
|
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
26,143
|
|
11,102
|
|
41,032
|
|
20,334
|
|
|
|
|
|
|
|
|
Operating Income
|
5,194
|
|
8,414
|
|
10,860
|
|
17,981
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
Interest
expense, net
|
(2,830)
|
|
(2,749)
|
|
(5,612)
|
|
(5,474)
|
Other
expense/income, net
|
(12)
|
|
-
|
|
(10)
|
|
68
|
|
|
|
|
|
|
|
|
Income Before
Provision for Income Taxes
|
2,352
|
|
5,665
|
|
5,238
|
|
12,575
|
|
|
|
|
|
|
|
|
Provision for Income
Taxes
|
(1,227)
|
|
(2,094)
|
|
(2,767)
|
|
(4,635)
|
|
|
|
|
|
|
|
|
Net Income
|
$
1,125
|
|
$
3,571
|
|
$
2,471
|
|
$
7,940
|
|
|
|
|
|
|
|
|
Basic Earnings Per
Share
|
|
|
|
|
|
|
|
Basic Earnings Per
Share
|
$
0.10
|
|
$
0.31
|
|
$
0.22
|
|
$
0.70
|
Diluted Earnings Per
Share
|
$
0.10
|
|
$
0.31
|
|
$
0.21
|
|
$
0.68
|
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
11,402
|
|
11,344
|
|
11,398
|
|
11,335
|
Diluted
Weighted-Average Shares Outstanding
|
11,541
|
|
11,549
|
|
11,514
|
|
11,556
|
|
|
|
|
|
|
|
|
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
June 30,
|
|
Six Months Ended
June 30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Net
Income
|
$
1,125
|
|
$
3,571
|
|
$
2,471
|
|
$
7,940
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
Interest
expense, net
|
2,830
|
|
2,749
|
|
5,612
|
|
5,474
|
Other
expense/income, net
|
12
|
|
-
|
|
10
|
|
(68)
|
Provision for income taxes
|
1,227
|
|
2,094
|
|
2,767
|
|
4,635
|
Depreciation and amortization
|
5,956
|
|
1,415
|
|
10,565
|
|
2,742
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
Stock-based compensation
|
2,217
|
|
1,029
|
|
3,322
|
|
1,597
|
Excess
of fair value over cost of acquired inventory
|
2,078
|
|
-
|
|
2,078
|
|
-
|
Adjusted non-GAAP EBITDA
|
$15,445
|
|
$10,858
|
|
$26,825
|
|
$22,320
|
|
|
|
|
|
|
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 3: Adjusted
non-GAAP Net Income and Adjusted non-GAAP Net Income per Diluted
Share Reconciliation
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income
|
$
1,125
|
|
$3,571
|
|
$
2,471
|
|
$
7,940
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
Tax provision
|
1,227
|
|
2,094
|
|
2,767
|
|
4,635
|
Depreciation and amortization expense
|
5,956
|
|
1,415
|
|
10,565
|
|
2,742
|
Non-cash interest expense
|
1,757
|
|
1,705
|
|
3,482
|
|
3,388
|
Stock-based compensation
|
2,217
|
|
1,029
|
|
3,322
|
|
1,597
|
Excess of fair value over cost of acquired inventory
|
2,078
|
|
-
|
|
2,078
|
|
-
|
Less
|
|
|
|
|
|
|
|
Current portion of tax provision
|
(1,563)
|
|
(1,937)
|
|
(3,183)
|
|
(4,175)
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
$12,797
|
|
$7,877
|
|
$21,502
|
|
$16,127
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
|
|
|
Shares
Outstanding
|
11,541
|
|
11,549
|
|
11,514
|
|
11,556
|
|
|
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
|
|
|
Net Income Per Diluted Share
|
$
1.11
|
|
$
0.68
|
|
$
1.87
|
|
$
1.40
|
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-record-second-quarter-results-and-increases-full-year-2016-guidance-300308832.html
SOURCE ANI Pharmaceuticals, Inc.